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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id1467
      • user_id693
      • trial_status_id(null)
      • abstract_of_study<div>\n <strong>BACKGROUND</strong></div>\n<div>\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div>\n  </div>\n<div>\n <strong>STUDY RATIONALE</strong></div>\n<div>\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div>\n  </div>\n<div>\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div>\n Primary Objective:</div>\n<div>\n To evaluate the long-term safety of astegolimab</div>\n<div>\n Corresponding Endpoint:</div>\n<div>\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div>\n  </div>\n<div>\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div>\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the sites targeting approximately five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div>\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p>\n A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</p>\n
      • laymans_summary<div>\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div>\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div>\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div>\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div>\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/09/02
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPhoebe Mercy Otieno
      • declaration_date123-09-2024
      • declaration_principal_investigatorProf. Videlis Nduba
      • declaration_date223-09-2024
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary Objective</strong></div>\n<ul>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<div>\n <strong>Exploratory Objectives</strong></div>\n<ul>\n <li>\n To evaluate the efficacy of astegolimab</li>\n <li>\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n <li>\n To characterize the PK profile of astegolimab</li>\n <li>\n To evaluate the immune response to astegolimab</li>\n <li>\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul>\n <li>\n Signed Informed Consent Form.</li>\n <li>\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li>\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li>\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li>\n Any permanent discontinuation of study drug in parent study</li>\n <li>\n <div>\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment.</div>\n </li>\n <li>\n <div>\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.\\</div>\n </li>\n <li>\n <div>\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</div>\n </li>\n</ul>\n<div>\n <ul>\n <li>\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study.</li>\n </ul>\n <div>\n <ul>\n <li>\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry.</li>\n <li>\n <div>\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study.</div>\n </li>\n <li>\n <div>\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab.</div>\n </li>\n <li>\n <div>\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study.</div>\n </li>\n <li>\n <div>\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</div>\n </li>\n <li>\n <div>\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</div>\n </li>\n <li>\n <div>\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</div>\n </li>\n </ul>\n </div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<div>\n <strong>Primary Objective Endpoints</strong></div>\n<div>\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n The study site is the University of Nairobi Clinical Research Centre (UNCRC) located in the Department of Human Anatomy and Medical Physiology at the Chiromo Campus of the University of Nairobi Faculty of Health Sciences. In this location administrative and archiving facilities are domiciled. The clinic facilities will be physical located in the KNH RIDU and laboratory facilities will be at the KAVI ICR. Recruitment, consenting, randomization and administration of IMP will be at the RIDU unit the chest clinic number 17.</div>\n<div>\n  </div>\n<div>\n <div>\n The research medical records unit, administrative offices, storage of the IP, laboratory testing and specimen packaging for shipping will be done at the KAVI ICR . which is well-staffed by trained personnel with expertise in the following research related tasks: Clinical officers: Participate in screening of potential patients based on the inclusion and exclusion criteria. Clinical Research Nurses: Obtain Informed consents, Make CRF entries/resolve queries; Collect medical information; Vital</div>\n <div>\n signs; Collect adverse events; Administer IP; Collect lab samples; Participant recruitment and retention. Pharmacist and Pharmacy Technologist: Investigational Drug Services: Manage IP receipt/return; Prepare and dispense IP; Unbinding procedures.</div>\n <div>\n  </div>\n <div>\n <div>\n Regulatory Affairs: Manage submissions to ethics and regulatory authorities. Maintain essential documents and ensure compliance Contracts and Budgets: Maintain legal and financial documents; Ensure appropriate invoicing to the sponsor; Ensure appropriate processes for research covered procedures versus patients’ standard of care Data Management: Make CRF entries/resolve queries; Maintain the patients’ research documents Clinical Research operations: Oversight of UNCRC studies</div>\n <div>\n and staff; support all research staff with their tasks Investigators: Obtain Informed Consent; Assess eligibility; Make CRF entries/resolve Queries; Medical decisions/review; Collect medical information; Vital signs; Assess 8 Ordinal Scale; Collect/Assess Adverse Events; Administer IP; Conduct Physical Exam; Collect Lab Samples; Maintain Essential Documents; IP processes The KNH Chest Clinic is part of the Respiratory Infectious Disease Unit (RIDU).</div>\n <div>\n  </div>\n <div>\n <div>\n The facility is designed to provide an integrated, patient-centered service across the care cycle from diagnosis, treatment, surveillance and palliative care.</div>\n <div>\n  </div>\n <div>\n <div>\n The ambulatory chest clinic also offers streamlined, efficient care by a multidisciplinary team of respiratory specialists. This coordinated approach provides comprehensive care and support for patients with lung disease and their caregivers. All patients treated at the KNH Respiratory Infectious Disease Unit (RIDU) will have access to smoking cessation, psychosocial and support counseling as well as palliative care support as part of best practice. This is not limited to non-study patients and thus is available to study patients as well. The UNCRC provides an approach to care which is guided by international standards including accreditation by the Kenya Medical Laboratory Technician and Technologist Board (KMLLTB) and IATA Shipping and Transport of Regulated Biologic Material certification.</div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Switzerland is the host country and Sponsor intends to submit study for approval in the host country.</p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 21px;\">\n <p>\n <strong>I</strong><strong>NDIA                                                                                DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 30-Apr-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width: 589px; height: 18px;\">\n <p>\n <strong>P</strong><strong>HILIPPINES</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 18-Apr-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n To be submitted</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 16-May-2024</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>K</strong><strong>ENYA</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 13-Jun-2024 (first site)</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width: 141px; height: 18px;\">\n <p>\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"width: 161px; height: 18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 287px; height: 18px;\">\n AUSTRIA</td>\n <td style=\"width: 141px; height: 18px;\">\n 25Jun2024</td>\n <td style=\"width: 161px; height: 18px;\">\n Pending expected by 24-Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:37px;\">\n <p>\n <strong>List of Competent Authorities inside the EU/EEA to which the Application Approved </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Member State </strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n GREECE, HUNGARY, ITALY, LATVIA</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 25-Jun-2024</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n  </p>\n <p>\n GREECE – Approved, 18-Sep2024</p>\n <p>\n HUNGARY - Approved, 03-Sep2024</p>\n <p>\n ITALY - Approved, 16-Sep2024</p>\n <p>\n LATVIA - Approved, 17-Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 25-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 22-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 02-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 18-Oct-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 24-Aug-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:21px;\">\n <p>\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:21px;\">\n  </td>\n <td style=\"width:161px;height:21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 28-Jul-2023 </p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 24-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 14-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 7-Jul2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 9-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 13-Feb-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 20-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Jul-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 21-May-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 25-Jun2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationStudy participation for each individual is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states39
      • number_of_sites5
      • multi_country_listAUSTRALIA, CHINA,HONG KONG,INDIA,JAPAN, NEW ZEALAND, PHILIPPINES, SOUTH KOREA, TAIWAN, THAILAND, BRAZIL, ARGENTINA, CANADA, CHILE, MEXICO, PERU, AUSTRIA, BELGIUM, BULGARIA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, HUNGARY, ITALY, LATVIA, NETHERLANDS, POLAND, ROMANIA, SPAIN, SWEDEN, ISRAEL, KENYA, SOUTH AFRICA, SWITZERLAND, TURKEY, UNITED KINGDOM, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteApproximately 4 participants for this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date13-11-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-09-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted23-09-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-07 15:34:17
      • created2024-09-06 06:58:08
      • total_sites
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1153
        • application_id1467
        • given_nameTeresa
        • middle_name
        • family_nameKinyari
        • qualificationMedical Doctor
        • professional_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • telephone+254 707028067
        • emailtmwendwa@uonbi.ac.ke
        • created2024-09-06 07:06:21
        • modified2024-11-06 10:00:24
    • SiteDetail(array)
      • 0(array)
        • id1779
        • application_id1467
        • county_id47
        • site_nameUniversity of Nairobi Clinical Research Centre
        • physical_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • contact_details+254 707028067
        • contact_personDr Teresa Kinyari
        • site_capacity(null)
        • misc(null)
        • created2024-09-06 07:06:21
        • modified2024-11-06 10:00:24
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1780
        • application_id1467
        • county_id3
        • site_nameKEMRI-Mtwapa Clinical Annex
        • physical_addressP.O. Box 428-80108, Mtwapa
        • contact_details+254722523370
        • contact_personDr Mary Matilu
        • site_capacity(null)
        • misc(null)
        • created2024-09-06 07:17:55
        • modified2024-11-06 10:00:24
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 2(array)
        • id1781
        • application_id1467
        • county_id47
        • site_nameCenter for Research In Tropical Medicine and Community Development
        • physical_addressP.O. Box 6387, Thika, Kenya
        • contact_details+254722425613
        • contact_personDr Jesse Gitaka
        • site_capacity(null)
        • misc(null)
        • created2024-09-06 07:17:55
        • modified2024-11-06 10:00:24
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1782
        • application_id1467
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-09-06 07:17:55
        • modified2024-11-06 10:00:24
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 4(array)
        • id1783
        • application_id1467
        • county_id47
        • site_nameKEMRI-CRDR Clinical Research Annex
        • physical_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • contact_details+254790484654
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-09-06 07:17:55
        • modified2024-11-06 10:00:24
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id779
        • application_id1467
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+ 41 6168 81111
        • fax_numberNot Available
        • cell_number+41 61 688 1111
        • email_addressglobal.eudract@roche.com
        • created2024-09-06 07:06:21
        • modified2024-11-06 10:00:24
  • 1(array)
    • Application(array)
      • id1458
      • user_id32
      • trial_status_id1
      • abstract_of_study<div>\n TITLE: Single-use antimalarial monoclonal antibodies for post-discharge malaria prevention in</div>\n<div>\n children with severe anaemia or severe malaria in Kenya: A multi-centre, parallel-group, two-arm</div>\n<div>\n randomised placebo-controlled non-inferiority trial (L9LS-pd).</div>\n<div>\n BACKGROUND AND RATIONALE: Hospitalised children with severe anaemia remain at high risk of</div>\n<div>\n dying or requiring hospital readmission for at least 6 months after discharge. In highly malariaendemic</div>\n<div>\n settings, malaria is a major contributor to these post-discharge readmissions and deaths. In</div>\n<div>\n 2022, the World Health Organisation (WHO) recommended post-discharge malaria</div>\n<div>\n chemoprevention (PDMC) for children hospitalised with severe anaemia living in malarious areas.</div>\n<div>\n Kenya, together with several other countries in sub-Saharan Africa, aims to expand WHO’s</div>\n<div>\n recommendation and introduce PDMC in children hospitalised with severe anaemia or severe</div>\n<div>\n malaria, including children with severe malaria who do not have severe anaemia (e.g. cerebral</div>\n<div>\n malaria). PDMC consists of full 3-day treatment courses with long-acting antimalarials given monthly</div>\n<div>\n three times after discharge. PDMC is very effective in clinical trials. However, adherence to these</div>\n<div>\n monthly 3-day drug treatments is limited under real-life conditions. Furthermore, PDMC provides</div>\n<div>\n chemoprevention for about 3.5 months only, while the risk of dying or needing to be readmitted</div>\n<div>\n remains high for several more months.</div>\n<div>\n The US National Institutes of Health (NIH) has developed two monoclonal antibodies targeting</div>\n<div>\n Plasmodium falciparum malaria (mMAb). These proteins specifically target a highly conserved</div>\n<div>\n epitope found on the circumsporozoite protein-1 (CSP-1) of P. falciparum to neutralize it and</div>\n<div>\n prevent malaria infection. A key feature of mMAbs is that they can provide protection for up to 6</div>\n<div>\n months with a single dose and thus serve as a “long-acting” drug. Recent placebo-controlled studies</div>\n<div>\n in healthy adults in Mali suggest that the first mMAb, CIS43LS, when administered at a dose of 40</div>\n<div>\n mg/kg intravenously (IV), can block 88% of malaria infections for at least 6 months. More recently,</div>\n<div>\n studies with a newer mMAb called L9LS, which is anticipated to be more potent than CIS43LS,</div>\n<div>\n showed a 74% reduction in uncomplicated clinical malaria by 6 months when administered</div>\n<div>\n subcutaneously to healthy Malian children aged 6-10 years by a single subcutaneous (SC) dose of 10-</div>\n<div>\n 20 mg/kg (NCT05304611). Similar studies with L9LS are ongoing in healthy children under 5 years of</div>\n<div>\n age in Siaya, western Kenya (NCT05400655).</div>\n<div>\n Young children admitted to hospitals in highly malaria-endemic areas with severe anaemia or severe</div>\n<div>\n malaria are an ideal target group for passive immunoprevention with mMAbs as a single infusion</div>\n<div>\n with mMAb while in the hospital could protect this high-risk group during the entire vulnerable postdischarge</div>\n<div>\n period.</div>\n<div>\n OVERVIEW DESIGN: We will conduct a 2-arm, multi-centre, individually randomised, placebocontrolled</div>\n<div>\n non-inferiority trial in 398 children with severe malaria or severe anaemia. Children will</div>\n<div>\n be randomly assigned (1:1) using an adaptive minimisation algorithm to receive either mMAb before</div>\n<div>\n discharge or 3 courses of monthly PDMC after discharge, according to WHO guidelines. The study</div>\n<div>\n will be placebo-controlled. Children in the PDMC arm will receive a placebo infusion with normal</div>\n<div>\n saline before discharge; children in the mMAb arm will receive placebo-PDMC. All children will</div>\n<div>\n receive standard in-hospital care, including a blood transfusion and treatment for severe malaria</div>\n<div>\n where indicated. They will also receive a full 3-day treatment course with the antimalarial</div>\n<div>\n artemether-lumefantrine (AL) to clear any existing malaria infections as soon as they have recovered</div>\n<div>\n and can take oral medication.</div>\n<div>\n The primary endpoint is the incidence of clinical malaria detected by passive case detection by 6</div>\n<div>\n months post-discharge (the intervention period). Key secondary endpoints include the rates of readmissions and deaths (all children). Children will be followed for another 6 months (postintervention</div>\n<div>\n period) to determine the duration of protection, any long-term impact (e.g., growth)</div>\n<div>\n and if mMAbs result in a delayed acquisition of natural protective immunity against clinical malaria.</div>\n<div>\n PRIMARY EFFICACY OBJECTIVE: To assess the efficacy of a single dose of L9LS versus PDMC against</div>\n<div>\n microscopy or RDT-confirmed clinical malaria in hospitalised children with severe anaemia or severe</div>\n<div>\n malaria by 6 months after investigational product (IP) administration.</div>\n<div>\n SITES: Two hospitals in western Kenya in areas with moderate to intense malaria transmission. The</div>\n<div>\n number of hospitals will be expanded if recruitment rates require this.</div>\n<div>\n STUDY POPULATION: Inclusion criteria: convalescent children aged less than 10 years and weighing</div>\n<div>\n ≥5 kg hospitalised with severe anaemia (haemoglobin<5g/dL / Ht<15%) or severe malaria who have</div>\n<div>\n become clinically stable and can take or switch to oral medication; post-transfusion Hb >5g/dL,</div>\n<div>\n resident in the study area, provision of informed consent by parents or guardian. Exclusion criteria:</div>\n<div>\n Children eligible for any of the four doses of the RTS,S or R21 malaria vaccines, HIV-infected or HIVexposed</div>\n<div>\n children on daily cotrimoxazole prophylaxis, blood loss due to trauma, malignancy, known</div>\n<div>\n bleeding disorders, known hypersensitivity to study drug, known heart conditions or family history</div>\n<div>\n of congenital QT prolongation, or taking medicinal products that are known to prolong the QTc</div>\n<div>\n interval, non-resident in the study area, previous participation in the study, known need at</div>\n<div>\n enrolment for prohibited medication and scheduled surgery during the 12-month course of the</div>\n<div>\n study.</div>\n<div>\n STUDY INTERVENTIONS: All children will receive standard in-hospital care, including a blood</div>\n<div>\n transfusion, antibiotics, and treatment for severe malaria where indicated. All children in both arms</div>\n<div>\n will be empirically treated for malaria infection around discharge with a 3-day regimen with</div>\n<div>\n artemether-lumefantrine to ensure parasite clearance of any existing parasites. Participants in the</div>\n<div>\n mMAb arm will receive the study agent L9LS IV with a target dose of 30 mg/kg. The IV dose will use 1</div>\n<div>\n kg step increases. During the 6-month intervention period, children in the placebo-mMAbs arm will</div>\n<div>\n receive three courses of monthly PDMC as per WHO guidelines with dihydroartemisinin-piperaquine</div>\n<div>\n (DP) at 2, 6 and 10 weeks post-discharge. Those in the mMAbs arm will receive an identical placebo</div>\n<div>\n PDMC. (Table 1, below).</div>\n<div>\n Table 1: Study arms</div>\n<div>\n Study arm</div>\n<div>\n mMAb (L9LS) + placebo-PDMC Placebo-mMAb + PDMC</div>\n<div>\n ï‚· Infusion with the mMAb L9LS before</div>\n<div>\n discharge</div>\n<div>\n ï‚· Placebo-PDMC at the end of weeks 2, 6,</div>\n<div>\n 10 post-discharge</div>\n<div>\n ï‚· Placebo-infusion with normal saline before</div>\n<div>\n discharge</div>\n<div>\n ï‚· PDMC with DP at the end of weeks 2, 6, 10</div>\n<div>\n post-discharge</div>\n<div>\n mMAb=Antimalarial monoclonal Antibody (L9LS). PDMC=post-discharge malaria chemoprevention</div>\n<div>\n DP=dihydroartemisinin-piperaquine.</div>\n<div>\n FOLLOW-UP PROCEDURES: Children will be followed for 12 months by passive surveillance</div>\n<div>\n (unscheduled sick visits) in 2 phases: a 6-month intervention period to the end of month 6 postdischarge</div>\n<div>\n (day 183 inclusive); a 6-month post-intervention period from month 7 to 12 inclusive (day</div>\n<div>\n 184 to +1 year minus 1 day following discharge).</div>\n<div>\n OUTCOME MEASURES: Primary: Incidence rate of clinical malaria from 3 to 26 weeks post-discharge,</div>\n<div>\n defined as an illness accompanied by measured fever ≥37.5°C or a history of fever (subjective or</div>\n<div>\n objective) in the previous 24 hours, accompanied by any level of asexual parasitaemia detected by</div>\n<div>\n microscopy or RDT (pLDH or HRP2-band). The HRP2-band results will only be considered when</div>\n<div>\n microscopy or the RDT pLDH band results are unavailable. Key secondary outcomes include the</div>\n<div>\n following outcomes measured during the follow-up periods (intervention and post-intervention): Allcause</div>\n<div>\n and cause-specific readmissions, all-cause non-severe sick-child clinic visits and those</div>\n<div>\n unrelated to malaria, and the pharmacokinetic parameters of L9LS. Other secondary efficacy</div>\n<div>\n outcomes include those measured during cross-sectional surveys conducted at the end of the</div>\n<div>\n intervention and post-intervention periods, including the prevalence of malaria infection, clinical</div>\n<div>\n malaria, anaemia, and standard anthropometric measures of malnutrition. Exploratory endpoints</div>\n<div>\n include immunological endpoints. Safety endpoints include solicited and unsolicited AEs (local and</div>\n<div>\n systemic) following mMAb administration and anti-drug antibodies (ADA) at 6 and 12 months.</div>\n<div>\n SAMPLE SIZE: This will be a parallel, 2-arm, placebo-controlled, non-inferiority trial using a 1:1</div>\n<div>\n allocation ratio. In this non-inferiority trial, we compare mMAbs against monthly PDMC, assuming</div>\n<div>\n higher incidence rates are worse. The primary endpoint is clinical malaria during 24 weeks between</div>\n<div>\n 3 and 26 weeks post-discharge. The non-inferiority ratio is 1.1. To demonstrate non-inferiority with</div>\n<div>\n 90% power and a one-sided significance level of 0.025 and assuming a potential reduction by</div>\n<div>\n mMAbs relative to PDMC of 54% (IRR=0.456) from 72 to 33 per 100 person-years, the study requires</div>\n<div>\n approximately 398 participants (199 per arm), considering a 15% dropout rate and an overdispersion</div>\n<div>\n parameter of 1.18. The trial includes two interim analyses for efficacy and sample size re-estimation</div>\n<div>\n when 50% and 75% of participants have completed their 6-month follow-up.</div>\n<div>\n DATA ANALYSIS: The primary analysis will use the modified intention-to-treat population, including</div>\n<div>\n all randomised participants contributing to the outcome. Incidence rates will be calculated, and</div>\n<div>\n incidence rate ratios will be estimated using negative binomial regression by treatment as</div>\n<div>\n randomised. The analysis time will be divided into a) the intervention period (first 6 months, primary</div>\n<div>\n analysis), b) the post-intervention period (6-12 months), c) and the cumulative effect by 12 months.</div>\n<div>\n If non-inferiority is demonstrated, an analysis for superiority will be conducted.</div>\n<div>\n IMPACT: The potential application of mMAb would be routine administration to hospitalised</div>\n<div>\n children with severe anaemia or severe malaria in highly malarious areas. The potential benefits</div>\n<div>\n include the prevention of post-discharge deaths, readmissions, and malaria episodes in these</div>\n<div>\n vulnerable groups of children.</div>\n<div>\n PARTNERS INSTITUTIONS: KEMRI, NIAID-NIH, LSTM, US-CDC</div>\n<div>\n FUNDING: NIH and CDC</div>\n<div>\n SPONSOR: LSTM</div>\n
      • study_title<div>\n Single-use antimalarial monoclonal antibodies for post-discharge malaria prevention in children with severe anaemia or severe malaria in Kenya: A multi-centre, parallel-group, two-arm randomised placebo-controlled non-inferiority trial (L9LS-pd)</div>\n
      • laymans_summary<div>\n Hospitalised children with severe anaemia or severe malaria remain at high risk of dying or requiring</div>\n<div>\n readmission after discharge for at least 6 months. In highly malaria-endemic settings, malaria is a</div>\n<div>\n major contributor. In 2022, the World Health Organisation (WHO) recommended post-discharge</div>\n<div>\n malaria prevention (PDMC) for children hospitalised with severe anaemia living in malarious areas.</div>\n<div>\n Kenya and several other countries in sub-Saharan Africa aim to expand WHO’s PDMC</div>\n<div>\n recommendation to children hospitalised with severe anaemia or severe malaria. PDMC consists of</div>\n<div>\n full 3-day treatment courses with long-acting antimalarials given monthly, three times after hospital</div>\n<div>\n discharge, providing about 14 weeks of protection. PDMC is very effective in clinical trials. However,</div>\n<div>\n previous studies showed that adherence to the monthly 3-day treatment course is limited under</div>\n<div>\n real-life conditions. Furthermore, PDMC only provides protection for 3.5 months, while the excess</div>\n<div>\n risk of dying or needing to be readmitted remains high for the first 6 months after discharge.</div>\n<div>\n The US National Institutes of Health (NIH) has developed a new intervention against malaria called</div>\n<div>\n an antimalarial monoclonal antibody (mMAb). These are laboratory-made versions of a naturally</div>\n<div>\n produced antibody specifically targeting the malaria parasite to neutralize and prevent infection. A</div>\n<div>\n key feature of mMAbs is that they can provide protection for up to 6 months with a single dose and</div>\n<div>\n thus serve as a “long-acting” drug. The first mMAb, CIS43LS, provided 88% protection against</div>\n<div>\n malaria infection for at least 6 months when given intravenously (IV) by infusion in healthy adults in</div>\n<div>\n Mali, West Africa. More recently, studies with a newer mMAb called L9LS showed a 74% reduction in</div>\n<div>\n malaria disease by 6 months when given by injection under the skin (subcutaneously [SC]) to healthy</div>\n<div>\n Malian children aged 6-10 years. Similar studies with L9LS are ongoing in healthy children under 5</div>\n<div>\n years of age in Siaya, western Kenya. All studies so far have demonstrated that mMAbs are safe and</div>\n<div>\n well tolerated. Hospitalised children with severe anaemia or severe malaria are an ideal target group</div>\n<div>\n for protection against malaria by mMAb in highly malaria-endemic areas because a single infusion</div>\n<div>\n with a mMAb, while still admitted in the hospital, could potentially protect them during the entire</div>\n<div>\n vulnerable 6-month post-discharge period. Furthermore, unlike malaria vaccines, which require</div>\n<div>\n three doses to provide protection, mMAbs provide immediate protection and don’t require the</div>\n<div>\n children to mount their own immune response, which can be variable.</div>\n<div>\n We propose a trial in 398 children hospitalised with severe anaemia or severe malaria in high</div>\n<div>\n malaria transmission areas in western Kenya. We will compare the efficacy and safety of an infusion</div>\n<div>\n with the mMAb L9LS provided before discharge to the standard-of-care with PDMC recommended</div>\n<div>\n by WHO. PDMC will comprise three 3-day treatment courses provided at 2, 6 and 10 weeks postdischarge</div>\n<div>\n with the long-acting antimalarial dihydroartemisinin-piperaquine (DP), the most effective</div>\n<div>\n antimalarial used in all previous PDMC trials. The study will be placebo-controlled. Children in the</div>\n<div>\n PDMC arm will receive a placebo infusion with normal saline before discharge; children in the</div>\n<div>\n mMAbs arm will receive placebo-PDMC with placebo tablets that look identical to the real DP. All</div>\n<div>\n children will receive standard in-hospital care, including a blood transfusion and treatment for</div>\n<div>\n severe malaria where indicated. They will also receive a full 3-day treatment course with the</div>\n<div>\n antimalarial artemether-lumefantrine (AL) to clear any existing malaria infections as soon as they</div>\n<div>\n have recovered and can take oral medication.</div>\n<div>\n Children will be followed for 1 year. We will compare the rates of clinical malaria between the</div>\n<div>\n mMAb and the PDMC arms by 6 months post-discharge (the end of the ‘intervention period’)</div>\n<div>\n (primary endpoint). We will also compare the rates of hospital readmissions and deaths. We will</div>\n<div>\n then follow them for another 6 months (post-intervention period) to determine the longevity of the</div>\n<div>\n protective effect and any longer-term benefits (e.g., on growth) or whether protection in the first 6</div>\n<div>\n months results in delayed malaria, e.g. due to delayed acquisition of natural protective immunity</div>\n<div>\n against malaria.</div>\n<div>\n Written informed consent will be obtained from caregivers. The potential application of mMAb</div>\n<div>\n would be routine administration to hospitalised children with severe anaemia or severe malaria in</div>\n<div>\n highly malarious areas.</div>\n
      • short_titleL9LS-PD
      • protocol_noECCT/24/09/01
      • version_no1.2
      • date_of_protocol31-07-2024
      • study_drugL9LS
      • disease_conditionMalaria
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_name0.9% Normal Saline
      • comparator_registeredYes
      • comparator_countriesGlobal
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRNjoroge@kemri.go.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantRuth Njoroge
      • declaration_date116-09-2024
      • declaration_principal_investigatorSimon Kariuki
      • declaration_date216-09-2024
      • placebo_presentYes
      • study_objectives<div>\n To assess the efficacy of a single dose of</div>\n<div>\n <div>\n L9LS versus PDMC against microscopy or</div>\n <div>\n RDT-confirmed clinical malaria in</div>\n <div>\n hospitalised children with severe</div>\n <div>\n anaemia or severe malaria by 6 months</div>\n <div>\n after investigational product (IP)</div>\n <div>\n administration</div>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n ï‚· Aged <10 years of both sexes</div>\n<div>\n ï‚· Severe anaemia or severe malaria: Initially hospitalised with haemoglobin <5.0 g/dl</div>\n<div>\n or PCV <15%, or requirement for blood transfusion for other clinical reasons on or</div>\n<div>\n during admission to the hospital, or severe malaria, defined as a requirement for</div>\n<div>\n parenteral artesunate in the opinion of the treating clinician and the presence of</div>\n<div>\n microscopy or RDT confirmed Plasmodium infection</div>\n<div>\n ï‚· Resident in catchment area</div>\n<div>\n ï‚· Post-transfusion haemoglobin >=5.0 g/dl or PCV >=15%</div>\n<div>\n ï‚· Clinically stable, able to take oral medication, able to feed (for breastfeeding</div>\n<div>\n children) or eat (for older children) and able to sit unaided (for older children who</div>\n<div>\n were already able to do so before hospitalisation)</div>\n<div>\n ï‚· Provision of informed consent by parent or guardian</div>\n
      • principal_exclusion_criteria<div>\n ï‚· Recognised specific other causes of severe anaemia (i.e., trauma, haematological</div>\n<div>\n malignancy, known bleeding disorders, such as haemophilia)</div>\n<div>\n ï‚· Sickle cell anaemia/sickle cell disease</div>\n<div>\n ï‚· Body weight <5 kg</div>\n<div>\n ï‚· Fever (≥37.5oC) on the day of enrolment is not an exclusion criterion as long as the</div>\n<div>\n child is considered clinically stable.</div>\n<div>\n ï‚· HIV infection or on daily cotrimoxazole prophylaxis.</div>\n<div>\n ï‚· Previous enrolment in the present study</div>\n<div>\n ï‚· Children who are scheduled to receive any of the four doses of the malaria vaccine</div>\n<div>\n within 6 months after enrolment.</div>\n<div>\n ï‚· Received any RTS,S or R21 malaria vaccine primary series or booster dose within</div>\n<div>\n the last 14 days inclusive</div>\n<div>\n ï‚· On or eligible for cotrimoxazole prophylaxis for HIV infection or HIV exposure</div>\n<div>\n ï‚· Children with sickle cell disease because they are eligible for daily proguanil</div>\n<div>\n ï‚· Known hypersensitivity to artemether-lumefantrine or dihydroartemisininpiperaquine</div>\n<div>\n ï‚· Anticipated to reside for more than 1 month of the 6-month (26 weeks)</div>\n<div>\n intervention period outside of the catchment area (e.g. boarding school)</div>\n<div>\n ï‚· Use or known need at enrolment for concomitant prohibited medication during the</div>\n<div>\n first 6 months post-discharge</div>\n<div>\n ï‚· Ongoing or planned participation in another clinical trial involving ongoing or</div>\n<div>\n scheduled treatment with prohibited medicinal products or active follow-up during</div>\n<div>\n the first 26 weeks post-discharge</div>\n<div>\n ï‚· A known need at the time of enrolment for scheduled surgery during the first 6</div>\n<div>\n months post-discharge</div>\n<div>\n ï‚· Suspected non-compliance with the follow-up schedule and protocol in the opinion</div>\n<div>\n of the investigator</div>\n<div>\n ï‚· Known heart conditions or family history of congenital prolongation of the QTc</div>\n<div>\n interval, or taking medicinal products that are known to prolong the QTc interval</div>\n
      • primary_end_points<div>\n Incidence rate of clinical malaria from 3 to 26</div>\n<div>\n weeks post-discharge, defined as an illness</div>\n<div>\n accompanied by measured fever ≥37.5°C or a</div>\n<div>\n history of fever (subjective or objective) in the</div>\n<div>\n previous 24 hours, accompanied by any level of</div>\n<div>\n asexual parasitaemia detected by microscopy or</div>\n<div>\n RDT (pLDH or HRP2-band). The HRP2-band results</div>\n<div>\n will only be considered when microscopy or the</div>\n<div>\n RDT pLDH band results are unavailable.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <u><strong>Homa Bay County Teaching and Referral Hospital</strong></u></div>\n<div>\n <u><strong>Clinical Trial Site Profile</strong></u></div>\n<div>\n 1. Facility Overview</div>\n<div>\n Homa Bay County Teaching and Referral Hospital is a 300-bed government healthcare facility in Homa Bay County, Kenya. As a teaching and referral hospital, it serves as an ideal location for conducting clinical trials, combining advanced medical care with research capabilities.</div>\n<div>\n 2. Location and Demographics</div>\n<div>\n • Situated approximately 110 kilometers (2-hour drive) from Kisumu</div>\n<div>\n •Located in an area of intense malaria transmission, providing access to a relevant patient population for tropical disease studies</div>\n<div>\n • Serves a diverse population, facilitating recruitment</div>\n<div>\n 3. Clinical Trial Infrastructure</div>\n<div>\n 3.1 Dedicated Clinical Trial Facility</div>\n<div>\n •Two well equipped laboratories dedicated for assessment of safety and analyses of laboratory parameters</div>\n<div>\n •</div>\n<div>\n GCP-compliant site pharmacy with secure storage and temperature monitoring systems</div>\n<div>\n •</div>\n<div>\n Multiple clinical rooms for participant care and study specific procedures</div>\n<div>\n •</div>\n<div>\n Secure data management room with backup power supply</div>\n<div>\n 3.2 Sample Processing and Storage</div>\n<div>\n •Capability for on-site sample processing, including centrifugation and aliquoting</div>\n<div>\n •-80°C freezers and liquid nitrogen storage for long-term sample preservation</div>\n<div>\n •Temperature-monitored sample storage</div>\n<div>\n 3.3 Pharmacy</div>\n<div>\n •Controlled access to investigational products</div>\n<div>\n •Temperature-controlled storage for drugs and vaccines</div>\n<div>\n •Capability for drug reconstitution and preparation on site</div>\n<div>\n 4. Research Team and Expertise</div>\n<div>\n •Multidisciplinary team includes:</div>\n<div>\n •Principal Investigator with extensive clinical trial experience</div>\n<div>\n •Sub-investigators and dedicated medical officers</div>\n<div>\n •GCP-trained research nurses and clinicians</div>\n<div>\n •Certified clinical research coordinators</div>\n<div>\n •Experienced laboratory technologists</div>\n<div>\n •Qualified pharmacist and pharmaceutical technologists</div>\n<div>\n •Trained data clerks for accurate data entry and management</div>\n<div>\n •Field workers for community engagement and participant follow-up</div>\n<div>\n 5. Quality Assurance and Regulatory Compliance</div>\n<div>\n •Regular internal audits and readiness for sponsor audits and regulatory inspections</div>\n<div>\n •Compliance with ICH-GCP guidelines and local regulatory requirements</div>\n<div>\n •Standardized Operating Procedures (SOPs) for all clinical trial processes</div>\n<div>\n 6. Data Management and Safety</div>\n<div>\n •Electronic Data Capture (EDC) system with secure, backed-up servers</div>\n<div>\n •Strict data privacy and protection measures in compliance with clinical trial requirements</div>\n<div>\n •Real-time data entry and regular data cleaning processes</div>\n<div>\n •Dedicated safety reporting system for Adverse Events (AEs) and Serious Adverse Events (SAEs)</div>\n<div>\n 7. Community Engagement and Participant Recruitment</div>\n<div>\n •Strong ties with the local community, facilitating recruitment and retention</div>\n<div>\n •Experienced community advisory board to ensure culturally appropriate engagement</div>\n<div>\n •Capability to conduct community awareness programs about clinical research</div>\n<div>\n 8. Collaborative Network</div>\n<div>\n Established partnerships with regional healthcare facilities for:</div>\n<div>\n •Extended participant recruitment</div>\n<div>\n •Long-term follow-up capabilities</div>\n<div>\n •Referral system for specialized care if required during trials</div>\n<div>\n Some collaborating facilities:</div>\n<div>\n 1. Kendu Bay Hospital</div>\n<div>\n 2. Rachuonyo Sub-County Hospital</div>\n<div>\n 3. Nyamira County Referral Hospital</div>\n<div>\n  </div>\n<div>\n 9. Clinical Trial Experience</div>\n<div>\n The Homa Bay County Teaching and Referral Hospital has a strong track record in as a site for clinical trials, particularly in areas relevant to the local disease burden. The experience includes, but is not limited to:</div>\n<div>\n •Post-Discharge Malaria Chemoprevention Trial: A recent study investigating the efficacy of Dihydroartemisinin-piperaquine for preventing malaria in children after hospital discharge. This trial demonstrates our capability to conduct complex, multi-phase studies involving follow-up care.</div>\n<div>\n •Malaria in Pregnancy Trials: Multiple studies focusing on the prevention and treatment of malaria in pregnant women, addressing a critical health concern in the region. Pregnancy registry platform</div>\n<div>\n •Other phase 2 and 3 clinical trials in paediatrics</div>\n<div>\n This diverse number of clinical trials showcases the site’s ability to:</div>\n<div>\n •Recruit and retain participants from various demographic groups</div>\n<div>\n •Implement complex study protocols</div>\n<div>\n •Manage and analyze large datasets</div>\n<div>\n •Collaborate with international research partners</div>\n<div>\n •Adhere to rigorous ethical and regulatory standards</div>\n<div>\n 10. Training</div>\n<div>\n •Regular GCP and research ethics training for all staff involved in clinical trials</div>\n<div>\n •Ongoing professional development programs for research team members</div>\n<div>\n •Collaboration with international research institutions for knowledge exchange</div>\n<div>\n  </div>\n<div>\n <div>\n <u><strong>Siaya County Referral Hospital</strong></u></div>\n <div>\n <u><strong>Clinical Trial Site Profile</strong></u></div>\n <div>\n 1. Facility Overview</div>\n <div>\n Siaya County Referral Hospital is a 260-bed public healthcare facility located in Siaya Town, Siaya County, western Kenya. As the main public hospital in the County, it serves primarily a rural population and plays a crucial role in healthcare delivery and medical research in the region</div>\n <div>\n 2. Location and Demographics</div>\n <div>\n •Situated in Siaya Town, Siaya County, western Kenya</div>\n <div>\n •Located in an area of high perennial malaria transmission in the lake region</div>\n <div>\n •Serves mainly a rural population, providing access to a relevant demographic for various clinical studies</div>\n <div>\n 3. Hospital Capacity and Specialties</div>\n <div>\n •Total capacity: 260 beds</div>\n <div>\n •General wards: 200 beds</div>\n <div>\n •Dedicated pediatric unit: 60 beds</div>\n <div>\n •Specializes in providing care for malaria and other prevalent conditions in the region</div>\n <div>\n 4. Research Infrastructure and Expertise</div>\n <div>\n It hosts a dedicated Clinical Research Centre (CRC), with over two decades of clinical trial experience. The CRC is equipped to handle various types of clinical studies, from early-phase trials to large-scale efficacy studies.</div>\n <div>\n It has experienced research staff familiar with Good Clinical Practice (GCP) and international research standards.</div>\n <div>\n The Siaya site also hosts the KEMRI/CDC Health and Demographic Surveillance System (HDSS) a crucial research infrastructure that provides extensive data and support for various studies. It Provides longitudinal population-based demographic information and data on disease burden, particularly focusing on common causes of morbidity and mortality in Kenya and East Africa.</div>\n <div>\n 5. Extensive Clinical Trial Experience</div>\n <div>\n The Siaya site has a rich history of conducting significant clinical trials, including but not limited to:</div>\n <div>\n Malaria Vaccine Trials: Participation in pivotal studies that have contributed to the development and testing of malaria vaccines, positioning the site at the forefront of malaria prevention research.</div>\n <div>\n Monoclonal Antibody (MmAB) Trials: Experience in conducting trials with advanced biologic therapies, including monoclonal antibodies, demonstrating capability in handling complex investigational products.</div>\n <div>\n Ongoing Studies with MmAB L9LS: Since 2022, the hospital has been conducting studies with MmAB L9LS in healthy children, showcasing their current involvement in cutting-edge malaria prevention research.</div>\n <div>\n Various other trials related to tropical diseases, paediatric health, and public health interventions relevant to the local population</div>\n <div>\n This extensive and diverse clinical trial experience highlights the site's ability to:</div>\n <div>\n •Implement complex study protocols</div>\n <div>\n •Manage a wide range of investigational products</div>\n <div>\n •Recruit and retain participants from various demographic groups</div>\n <div>\n •Collaborate effectively with international sponsors and research organizations</div>\n <div>\n •Contribute significantly to the advancement of medical knowledge, particularly in the fields of malaria and tropical diseases</div>\n <div>\n 6. Collaborative Network</div>\n <div>\n Siaya CRC collaborates closely with other healthcare facilities in the region to enhance patient care, research, and medical education. Some collaborating facilities include:</div>\n <div>\n 1. Bondo Sub-County Referral Hospital</div>\n <div>\n 2. Madiany Sub-County Hospital</div>\n <div>\n 3. Uyawi Sub-County Hospital</div>\n <div>\n 4. Other hospitals and lower-level health facilities in Kisumu and neighboring Counties</div>\n <div>\n These partnerships facilitate:</div>\n <div>\n •Patient enrollment in medical studies</div>\n <div>\n •Follow-up care for trial participants</div>\n <div>\n •Comprehensive healthcare coverage for the region</div>\n <div>\n •Extended reach for clinical trials and research initiatives</div>\n <div>\n 7. Malaria Research Focus</div>\n <div>\n •The hospital's location in an area of high perennial malaria transmission makes it an ideal site for malaria-related studies</div>\n <div>\n •Experience with malaria studies in paediatric populations</div>\n <div>\n •Potential for year-round recruitment of malaria cases for clinical trials</div>\n <div>\n 8. Paediatric Expertise</div>\n <div>\n •Dedicated 60-bed paediatric unit</div>\n <div>\n •Experience in conducting paediatric clinical trials, as evidenced by the ongoing MmAB L9LS studies with dedicated paediatrician-scientists.</div>\n <div>\n •Capability to manage complex paediatric cases, which is crucial for child-focused clinical trials</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n LSTM</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration> 3 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator0.9% normal saline
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site398
      • total_participants_worldwide398
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren aged below 10 years
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFeiko
      • investigator1_middle_name
      • investigator1_family_nameter Kuile
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressLiverpool School of Tropical Medicine (LSTM) Pembroke Place, L3 5QA Liverpool, United Kingdom and 1578 - 40100 KEMRI-CGHR Kisumu, Kenya.
      • investigator1_telephone+254 708 739 228
      • investigator1_emailFeiko.terkuile@lstmed.ac.uk
      • organisations_transferred_No
      • number_participants398
      • notification
      • approval_date16-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-09-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted16-09-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonSatisfactory feedback was provided upon ECCT review, with the pending response on MTA and QP declaration
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-07 15:01:43
      • created2024-08-12 11:33:06
      • total_sites2
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1160
        • application_id1458
        • given_nameMary
        • middle_nameIwaret
        • family_nameOtiti
        • qualificationMD
        • professional_address1578 - 40100 KEMRI-CGHR Kisumu, Kenya
        • telephone0724007076
        • emailiwaret.otiti@lstmed.ac.uk
        • created2024-09-11 06:13:40
        • modified2025-01-15 17:49:31
    • SiteDetail(array)
      • 0(array)
        • id1787
        • application_id1458
        • county_id43
        • site_nameHoma Bay County Teaching and Referral Hospital
        • physical_addressHoma Bay Town
        • contact_details+254724007076
        • contact_personDr. Mary Iwaret Otiti
        • site_capacity(null)
        • misc(null)
        • created2024-09-11 06:13:40
        • modified2025-01-15 17:49:31
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
      • 1(array)
        • id1788
        • application_id1458
        • county_id41
        • site_nameSiaya County Referral Hospital
        • physical_addressSiaya Town
        • contact_details+254724007076
        • contact_personDr. Mary Iwaret Otiti
        • site_capacity(null)
        • misc(null)
        • created2024-09-11 06:58:58
        • modified2025-01-15 17:49:31
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id782
        • application_id1458
        • sponsorLiverpool School of Tropical Medicine (LSTM)
        • sponsor_typeResearch Institution
        • contact_person
        • addressPembroke Place, Liverpool L3 5QA, UK
        • telephone_number+44 0151 7053794
        • fax_number
        • cell_number+44 0151 7053794
        • email_addresslstmgov@lstmed.ac.uk
        • created2024-09-11 06:13:40
        • modified2025-01-15 17:49:31
  • 2(array)
    • Application(array)
      • id1448
      • user_id659
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong><u>Trial Design:</u></strong></p>\n<p>\n This will be a multicenter, open-label, randomized, parallel-group, non-inferiority study in adults and children with uncomplicated P. falciparum malaria (P. falciparum with or without other Plasmodium spp. co-infection). After completion of the Core phase of the study, patients may enter in the Extension phase (single-group).</p>\n<p>\n <strong><u>Purpose:</u></strong></p>\n<p>\n This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).</p>\n<p>\n In the Extension phase, the safety, tolerability and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase</p>\n<p>\n <strong><u>Study Rationale:</u></strong></p>\n<p>\n This Phase 3 study includes a Core phase and an Extension phase.</p>\n<p>\n The Core phase of this study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for 3 days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection) in order to support marketing authorization application for KLU156. There is an unmet medical need for anti-malarial combination treatment including a partner drug with a new mechanism of action to counter the emergence of resistance to artemisinin.</p>\n<p>\n The Extension phase is designed to assess the safety, tolerability and efficacy of repeated treatment with KLU156 for a maximum of two years in patients who have completed the Core phase without experiencing early treatment failure (ETF) nor any study treatment-related SAE and who consent to participate in the Extension phase.</p>\n<p>\n  </p>\n<p>\n <strong><u>P</u></strong><strong><u>rimary objective(s) </u></strong></p>\n<p>\n ● Core phase:</p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To confirm the efficacy of KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P.falciparum (with or without other Plasmodium spp. coinfection) by demonstrating that KLU156 is noninferior to Coartem (non‑inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>Secondary objective(s)</u></strong></p>\n<p>\n ● Core phase:</p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Key secondary objective: To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>●</u></strong><strong><u> Extension phase:</u></strong></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To evaluate efficacy over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong><u>Exploratory objective(s)</u></strong></p>\n<p>\n ● <strong>Core phase:</strong></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the transmission-blocking activity of KLU156 (direct membrane feeding assay (DMFA)) at selected sites</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To quantify parasites that are below the detection level of microscopy using quantitative PCR (qPCR) as a diagnostic tool.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the impact of PCR methods on efficacy estimates.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess <em>in vitro </em>susceptibility profile of tested parasites at selected sites (if feasible).</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the effect of the main ADME gene factors on ganaplacide PK at selected sites (if feasible).</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To assess the pharmacokinetics of ganaplacide and lumefantrine in malaria patients.</li>\n</ul>\n<ul style=\"list-style-type:circle;\">\n <li>\n To explore the acceptability, palatability and ease of administration of KLU156.</li>\n</ul>\n<p>\n Ø  To explore the emergence of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the efficacy over repeated treatment with KLU156.</p>\n<p>\n To explore the emergence and/or selection of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy, upon repetitive treatment.</p>\n<p>\n  </p>\n<p>\n <strong>Study Population:</strong></p>\n<p>\n The study population will consist of male and female patients ≥ 5 kg of body weight and ≥ 2 months of age with confirmed uncomplicated <em>P. falciparum </em>malaria. Only patients with malaria symptoms and a <em>P. falciparum </em>count ≥ 1,000 parasites/μL and ≤ 200,000 parasites/μL (with or without other <em>Plasmodium </em>spp. co-infection) will be included in the study. Approximately 1,500 patients will be enrolled in the study (see <strong><u>Section 9.9 of the Protocol v00</u></strong> for more details on sample size determination).</p>\n
      • study_title<p>\n A randomized, open-label, multicenter study to compare efficacy, safety and tolerability of KLU156 with Coartem® in the treatment of uncomplicated Plasmodium falciparum malaria in adults and children ≥ 5 kg body weight followed by an Extension phase with repeated KLU156 treatment </p>\n
      • laymans_summary<p>\n Analysis of the efficacy, safety and tolerability of a new combination of ganaplacide and lumefantrine in adults and children with uncomplicated malaria</p>\n
      • short_titleKALUMA Study
      • protocol_noECCT/24/08/06
      • version_no00
      • date_of_protocol14-06-2022
      • study_drugKLU156 (Ganaplacide/Lumefantrine Solid Dispersion Formulation)
      • disease_conditionUncomplicated Plasmodium falciparum malaria
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameKLU156 (Ganaplacide/Lumefantrine Solid Dispersion Formulation)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameCoartem/Riamet Dispersible & Comparator. Coartem/Riamet 80/480mg
      • comparator_registeredyes
      • comparator_countriesCountry Local Brand Name Marketing Authorization Holder – Company name \nBenin Coartem Novartis Pharma AG \nBotswana Riamet Novartis Pharma Services AG \nBurkina Faso Coartem Novartis Pharma AG \nCameroon Coartem Novartis Pharma AG \nCongo (Brazzaville) Coartem Novartis Pharma AG \nCongo, Democratic Republic Coartem Novartis Pharma AG \nEthiopia Coartem Novartis Pharma Schweiz AG \nGabon Coartem Novartis Pharma AG \nGhana Coartem Novartis Pharma Services AG \nGuinea Coartem Novartis Pharma AG \nIvory Coast Coartem Novartis Pharma AG \nKenya Coartem NVS Kenya Ltd \nLiberia Coartem Novartis Pharma Services AG \nMadagascar Riamet Novartis Pharma Services AG \nMalawi Riamet Novartis Pharma Services AG \nMali Coartem Novartis Pharma AG \nMozambique Riamet Medis Farmaceutica Lda \nNamibia Coartem Novartis Pharma Services AG \nNiger Coartem Novartis Pharma AG \nNigeria Coartem Novartis Nigeria Limited \nSenegal Coartem Novartis Pharma AG \nSudan Coartem Novartis Pharma Schweiz AG \nTanzania Riamet NVS Kenya Ltd \nTogo Coartem Novartis Pharma AG \nUganda Riamet NVS Kenya Ltd \nZambia Riamet Novartis Pharma Services AG \nZimbabwe Riamet Novartis Pharma Services AG \n
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressraps.clinicaltrials@novartis.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDenish Maisiba
      • declaration_date121-08-2024
      • declaration_principal_investigatorBernhards Ogutu
      • declaration_date221-08-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong><u>P</u></strong><strong><u>rimary objective(s) </u></strong></p>\n<p>\n ● Core phase:</p>\n<p>\n Ø  To confirm the efficacy of KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by P.falciparum (with or without other Plasmodium spp. coinfection) by demonstrating that KLU156 is noninferior to Coartem (non‑inferiority margin = 5%) based on the PCR-corrected ACPR at Day 29.</p>\n<p>\n  </p>\n<p>\n <strong><u>Secondary objective(s)</u></strong></p>\n<p>\n ● Core phase:</p>\n<p>\n Ø  Key secondary objective: To further confirm the efficacy of KLU156 by demonstrating non-inferiority of KLU156 to Coartem (NI margin 7.5%) based on the uncorrected ACPR at Day 29</p>\n<p>\n Ø  To confirm the efficacy of KLU156 by assessing uncorrected and PCR-corrected ACPR at additional time points, as well as fever and parasite clearance times (FCT and PCT), gametocyte carriage over time between the two treatment arms.</p>\n<p>\n Ø  To compare the safety and tolerability profile of the two treatment arms on AEs, general laboratory, vital signs and ECG measurements.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the safety and tolerability over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</p>\n<p>\n Ø  To evaluate efficacy over repeated treatment with KLU156 in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated malaria caused by <em>P. falciparum </em>(with or without other <em>Plasmodium </em>spp<em>. </em>co-infection) for a maximum of 2 years.</p>\n<p>\n  </p>\n<p>\n <strong><u>Exploratory objective(s)</u></strong></p>\n<p>\n  </p>\n<p>\n ● <strong>Core phase:</strong></p>\n<p>\n Ø  To explore the transmission-blocking activity of KLU156 (direct membrane feeding assay (DMFA)) at selected sites</p>\n<p>\n Ø  To quantify parasites that are below the detection level of microscopy using quantitative PCR (qPCR) as a diagnostic tool.</p>\n<p>\n Ø  To explore the impact of PCR methods on efficacy estimates.</p>\n<p>\n Ø  To assess <em>in vitro </em>susceptibility profile of tested parasites at selected sites (if feasible).</p>\n<p>\n Ø  To assess the effect of the main ADME gene factors on ganaplacide PK at selected sites (if feasible).</p>\n<p>\n Ø  To assess the pharmacokinetics of ganaplacide and lumefantrine in malaria patients.</p>\n<p>\n Ø  To explore the acceptability, palatability and ease of administration of KLU156.</p>\n<p>\n Ø  To explore the emergence of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy.</p>\n<p>\n  </p>\n<p>\n ● <strong>Extension phase:</strong></p>\n<p>\n Ø  To assess the efficacy over repeated treatment with KLU156.</p>\n<p>\n To explore the emergence and/or selection of drug resistance markers and the relationship between parasite genotypes of interest and parasite clearance kinetics/efficacy, upon repetitive treatment</p>\n
      • principal_inclusion_criteria<p>\n <strong>Key Inclusion criteria (Core phase):</strong></p>\n<p>\n 1. Male or female patients ≥ 5 kg of body weight and ≥ 2 months of age</p>\n<p>\n 2. Microscopically confirmed diagnosis of uncomplicated <em>P. falciparum </em>malaria with an asexual <em>P. falciparum </em>parasitemia ≥ 1,000 and ≤ 200,000 parasites/μL at the time of pre-screening with or without other <em>Plasmodium </em>spp. co-infection.</p>\n<p>\n 3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally)</p>\n<p>\n 4. Negative pregnancy test for patients of childbearing potential</p>\n<p>\n 5. Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards</p>\n<p>\n 6. The patient and/or their parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Key Exclusion criteria (Core phase)</strong></p>\n<p>\n 1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization)</p>\n<p>\n 2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19)</p>\n<p>\n 3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) < 16.0. For children < 12 years: less than 70% of median normalized WHO reference weight or very low midupper arm circumference (MUAC < 115 mm)</p>\n<p>\n 4. Repeated vomiting (defined as > 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as > 3 watery stools in the 24 hours prior to start of screening)</p>\n<p>\n 5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g.,hypokalemia, hypocalcemia or hypomagnesemia</p>\n<p>\n 6. Anemia (hemoglobin level <7 g/dL)</p>\n<p>\n 7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment),</p>\n<p>\n or which may jeopardize the patient in case of participation in the study.</p>\n<p>\n 8. Any of the following:</p>\n<p style=\"margin-left:.2in;\">\n • Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) > 3 x the upper limit of normal (ULN), regardless of the</p>\n<p style=\"margin-left:.2in;\">\n     level of total bilirubin</p>\n<p style=\"margin-left:.2in;\">\n • Total bilirubin > 3 x ULN</p>\n<p style=\"margin-left:.2in;\">\n • Resting QT interval corrected by Fridericia’s formula (QTcF) > 450 ms at screening</p>\n<p>\n 9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown)</p>\n<p>\n 10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease</p>\n<p>\n 11. Pregnant or nursing (lactating) patients.</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n <strong><u>Endpoint(s) for primary objective(s)</u></strong></p>\n<p>\n PCR-corrected adequate clinical and parasitological response (ACPR) at Day 29 (i.e., 28 days post-first</p>\n<p>\n dose administration)</p>\n<p>\n  </p>\n<p>\n <strong><u>Endpoint(s) for secondary objective(s)</u></strong></p>\n<p>\n <strong>Core Phase</strong>:</p>\n<p>\n  </p>\n<p>\n Ø  Uncorrected ACPR at Day 29</p>\n<p>\n Ø  PCR-corrected and uncorrected ACPR at Days 22 and 43 (i.e., 21 and 42 days post-first dose administration). Incidence rate of recrudescence and new infection at Days 22, 29 and 43. Parasite and Fever Clearance Times. Proportion of patients with parasitemia at 12, 24, 48 and 72 h after treatment. Disappearance or development of gametocytemia in patients with or without gametocytemia at baseline (pre-first dose administration), respectively.</p>\n<p>\n Ø  Standard safety/tolerability assessments: Adverse event (AE)/serious adverse event (SAE) incidence and severity, laboratory abnormalities and ECG abnormalities.</p>\n<p>\n  </p>\n<p>\n <strong>Extension Phase:</strong></p>\n<p>\n Ø  KLU156-related AE/SAE incidence and severity by malaria episode. AE/SAE incidence and severity, laboratory abnormalities and ECG abnormalities by malaria episode.</p>\n<p>\n Ø  PCR-corrected and uncorrected ACPR at Day 29 by malaria episode. Gametocyte carriage over time by malaria episode.</p>\n<p>\n  </p>\n<p>\n <strong><u>Endpoint(s) for exploratory objective(s)</u></strong></p>\n<p>\n <strong>Core Phase</strong>:</p>\n<p>\n  </p>\n<p>\n Ø  Direct membrane feeding assay will be performed at selected sites to assess the transmission-blocking activity by determining oocyst density and infection prevalence in female <em>Anopheles gambiae </em>mosquito colonies.</p>\n<p>\n Ø  Presence of sub-microscopic density of <em>P.falciparum </em>asexual forms at baseline, Day 1 (6h, 12h), Day 2 (24h, 36h), Day 3 (48h), Days 4, 22, 29, and 43, parasite clearance time using qPCR.</p>\n<p>\n Ø  Proportion of patients with PCR corrected and uncorrected ACPR at Days 22, 29 and 43 using different parasite genotyping methods and algorithms.</p>\n<p>\n Ø  Parasite susceptibility to ganaplacide and lumefantrine <em>in vitro</em>.</p>\n<p>\n Ø  Associations between ganaplacide Day 8 levels and pharmacogene Open Reading Frame (ORF) Diversity.</p>\n<p>\n Ø  Drug concentration at 48 h, 54 h and 168 h.</p>\n<p>\n Ø  Response to questionnaire of acceptability, palatability and ease of administration.</p>\n<p>\n Ø  Presence of parasite specific gene mutations (<em>pfmdr1, pfcrt, pfkelch13, pfcarl</em>, <em>pfugt </em>and additional parasite genes of interest).</p>\n<p>\n  </p>\n<p>\n <strong>Extension Phase:</strong></p>\n<p>\n Ø  Incidence rate of recrudescence and new infections at Day 29 by malaria episode. Incidence rate of malaria episode for a maximum of 2 years.</p>\n<p>\n Presence of parasite specific gene mutations (<em>pfmdr1, pfcrt, pfkelch13, pfcarl</em>, <em>pfugt </em>and additional parasite genes of interest) along the time of trial</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyTolerability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>Site 1600:</u></strong></p>\n<p>\n KEMRI/CGHR- Kenya Medical Research Institute/Centre for Global Health Research, Kisumu, Kenya, Off Kisumu-Busia Road, P.O.Box 1578- 40100, Kisumu</p>\n<p>\n The Siaya County Referral Hospital Clinical Research Center</p>\n<p>\n The KEMRI/Centre for Global Health Research facility is situated with the Siaya County Referral Hospital (SCRH). The SCRH is the largest hospital in Siaya County, western Kenya and is designed for care and treatment of all medical (pediatric and adult), surgical and obstetric patients, both in the outpatient and inpatient settings. This is a level four referral facility that provides healthcare to the general public in the whole of Siaya County and some adjacent counties - Busia, Vihiga and Kisumu.</p>\n<p>\n The hospital has a total bed capacity of 420 patients that include 50 in the pediatric inpatient ward and 100 in the adult medical wards (both male and female wards). Additional special units in addition to the traditional inpatient wards include a Renal/Dialysis unit and an intensive care unit with bed capacities of 5 each. Currently, the ICU has only 2 functional beds/ventilators in operation. The hospital is staffed by consultant doctors in all the general disciplines, medical officers, Pharmacists, Dentists, clinical officers, nurses, radiographers and sonographers, laboratory and pharmaceutical technologists. The specialist doctors include two Pediatricians, two Physicians/Internists, three Surgeons, one Psychiatrist, one psychologist and an Obstetrician/Gynecologist.</p>\n<p>\n The site has a waste disposal policy and this in in line with the regulatory requirements of the hospital. There is also a quality assurance policy which is implemented at the hospital according to ISO standards. The hospital has an ISO-accredited laboratory capable of carrying routine tests including biochemistry, hematology, microbiology and basic microscopy.</p>\n<p>\n <strong><u>Site 1601:</u></strong></p>\n<p>\n Kombewa Clinical Research Centre, Off Kisumu-Bondo Road, Opposite Kombewa County Hospital,</p>\n<p>\n P.O. Box 54-40100, Kisumu Kenya</p>\n<p>\n Kombewa CRC has adequate staff and facilities to conduct the trial. The site has the following cadres of staff; 4 pediatrician, 4 medical offices, 1 regulatory officer, 5 study coordinators, 6 clinical officers, 7 Lab technologist, 9 nurses, 1 pharmacist, 2 pharmaceutical technologist, 6 data clerks and 38 filed workers. The unit has two storey building consisting of office space, laboratory, clinical rooms, pharmacy, emergency room, observation room and records storage rooms.</p>\n<p>\n  </p>\n<p>\n <strong><u>Site 1602</u></strong>:</p>\n<p>\n Ahero Clinical Trials Unit. P.O.BOX 54-40100 Kisumu-Kenya</p>\n<p>\n  </p>\n<p>\n Ahero Clinical Trials Unit site is located within the Ahero county hospital in Nyando Sub- County, Kisumu County. Ahero County Hospital is level 4 hospital, with a bed capacity of 40, which receives referral from surrounding peripheral health facilities within Nyando Sub County and is able to accommodate both outpatient and in-patient adults and pediatric patients for several days.</p>\n<p>\n Staffing [ Human Workforce]</p>\n<p>\n The hospital has a total staff of over 100 health workers including, 2 Medical Officers,15 Clinical Officers,1 Pharmacist, 6 pharmaceutical technologists, Laboratory technologists and 40 Nurses.</p>\n<p>\n The Study Site in addition has: 2 Pediatricians,1 Medical Officer,3 Clinical officers,6 nurses,2 Pharmacist ,1 Pharmaceutical technologist ,1 Pharmaceutical technician, 1Field Coordinator, 2 Field Supervisors, 22 Community health workers, 1Data Manager,4 Data Clerks, 5 Laboratory technologist ,1 laboratory technician and microscopists with certificate for malaria microscopy proficiency testing (PT), regulatory officers, quality assurance officers and administrative officer. Some of our investigators are also part of Ethical Committee at SERU.</p>\n<p>\n  </p>\n<p>\n <strong><u>Institutional facilities</u></strong></p>\n<p>\n Ahero Clinical Trials Unit which is within the Ahero County Hospital is mainly used for research related activities including clinical trials. It holds clinical rooms, emergency room with a fully equipped crash cart, temperature-controlled pharmacy and laboratory, data room with stable internet connectivity for 24hours, Active Archival storage space and monitoring room.</p>\n<p>\n There are also several facilities within the hospital, which complement research activities. These include:</p>\n<p>\n •An ISO 15189:2012 accredited laboratory which is well-equipped and that handles both routine and specialized tests including, biochemistry, hematology and microbiology.</p>\n<p>\n •Adult and Pediatric wards that can accommodate any admission referral from the study</p>\n<p>\n •Vital signs equipment is available in both the out-patient and in-patient departments and at the Ahero Clinical Trials Unit site. The study site has also 1 ECG machine as well.</p>\n<p>\n •Continuous supply of oxygen from commercial supply from bulk oxygen cylinder.</p>\n<p>\n  </p>\n<p>\n <strong><u>Waste Management and Handling.</u></strong></p>\n<p>\n The site has established protocols for waste handling and disposal. This is based on sorting the</p>\n<p>\n waste according to the different biohazard level. The waste is then disposed according to protocol.</p>\n<p>\n There is an incinerator at the hospital to assist in the proper destruction and disposal of the waste.</p>\n<p>\n  </p>\n<p>\n <strong><u>Quality assurance policies and protocols.</u></strong></p>\n<p>\n The site has quality assurance SOPs that it follows for all its procedures. The staff are well trained</p>\n<p>\n and refresher courses are offered on a regular basis. Quality control / quality assurance checks and</p>\n<p>\n source data verification happens on the three major levels:</p>\n<p>\n Level 1 – Self Quality Check: Done on completion of study procedures while still seated with the</p>\n<p>\n participant</p>\n<p>\n Level 2 – Quality Control Check: Which entails QC checks that will be performed by the clinic</p>\n<p>\n QA officer/MO/SSC on a real-time basis and any errors picked will be addressed there and then.</p>\n<p>\n Level 3 – Quality Assurance Check: Done level are done at the data entry center by the data entry</p>\n<p>\n team during the receiving of the data from the field, clinics and during entry into the data base</p>\n<p>\n system to assure completeness and legibility.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n <span class=\"normaltextrun\"><span style=\"font-size: 9pt; line-height: 107%; font-family: Calibri, sans-serif; color: black; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">Malaria is not endemic in Switzerland. Hence, the trial cannot be conducted in Switzerland.</span></span><span class=\"eop\"><span style=\"font-size: 9pt; line-height: 107%; font-family: Calibri, sans-serif; color: black; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\"> </span></span></p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>Agency</strong></p>\n </td>\n <td style=\"width:160px;\">\n <p align=\"center\">\n <strong>HA submission Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Burkina Faso</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n ANRP</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 17-Oct-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Gabon</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n ANMAPS</p>\n </td>\n <td style=\"width:160px;\">\n <p>\n 15-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Ghana</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n Ghana FDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 10-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Rwanda</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n Rwanda FDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 03-May-2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:20px;\">\n <p>\n Uganda</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n NDA</p>\n </td>\n <td style=\"width:160px;height:20px;\">\n <p>\n 25-Oct-2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>HA approval</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>No. of sites</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n DRC</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n 30-Oct-2023</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n India</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 20-Feb-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:22px;\">\n <p>\n Ivory Coast</p>\n </td>\n <td style=\"width:213px;height:22px;\">\n <p>\n 25-Apr-2024</p>\n </td>\n <td style=\"width:213px;height:22px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Niger</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 07-Mar-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 24-May-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Tanzania</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 27-May-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Mali</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 18-Mar-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;height:20px;\">\n <p>\n Burkina Faso</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 15-Jan-2024</p>\n </td>\n <td style=\"width:213px;height:20px;\">\n <p>\n 1</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Reason for rejection</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n  N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_halted<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Country</strong></p>\n </td>\n <td style=\"width:213px;\">\n <p align=\"center\">\n <strong>Reason for halt of trial</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n N/A</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • estimated_durationThe study duration will be 43 days (Core phase) plus 24 months (Extension phase).
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorCoartem/Riamet
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states15
      • number_of_sites3
      • multi_country_listBurkina Faso\nIvory Coast\nGabon\nGhana\nIndia\nKenya\nMali\nMozambique\nNiger\nRwanda\nTanzania\nZambia\nDRC\nUganda\nNigeria\n
      • data_monitoring_committeeYes
      • total_enrolment_per_siteA maximum of 60 patients per site across all 3 sites
      • total_participants_worldwideApproximately 1,500 patients
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyminors (Children from 2 to 12 years of age) require Legal Guardian / parental signature and approval
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationM Med
      • investigator1_professional_addressStrathmore University – CREATES
      • investigator1_telephone254733966065
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_No
      • number_participants180
      • notification
      • approval_date26-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-08-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted22-08-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-06 13:35:21
      • created2024-07-26 13:38:14
      • total_sites3
      • ecitizen_invoice322282
    • InvestigatorContact(array)
      • 0(array)
        • id1116
        • application_id1448
        • given_nameDr Patricia
        • middle_nameOdera
        • family_nameOjwang
        • qualificationMBChB, Master of Medicine in Paediatrics and Child health
        • professional_addressKEMRI/CGHR- Kenya Medical Research Institute/Centre for Global Health Research, Kisumu, Kenya,
        • telephone254 720 487 325
        • emailpattojey@gmail.com or pojwang@kemri.go.ke
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
      • 1(array)
        • id1119
        • application_id1448
        • given_nameDr. Bernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MMED Paediatrics and Child health
        • professional_addressKombewa Clinical Research Centre, Off Kisumu-Bondo Road, Opposite Kombewa County Hospital,
        • telephone+254 733 811613 or +254 733 333530
        • emailOgutu6@gmail.com
        • created2024-07-30 03:16:28
        • modified2024-10-29 11:19:44
      • 2(array)
        • id1120
        • application_id1448
        • given_nameDr.Bernhards
        • middle_name
        • family_nameOgutu
        • qualificationMBChB, MMED Paediatrics and Child health
        • professional_addressAhero Clinical Trials Unit. P.O.BOX 54-40100 Kisumu-Kenya
        • telephone+254 733 811613 or +254 733 333530
        • emailOgutu6@gmail.com
        • created2024-07-30 03:16:28
        • modified2024-10-29 11:19:44
    • SiteDetail(array)
      • 0(array)
        • id1758
        • application_id1448
        • county_id41
        • site_nameSite 1600: Kenya Medical Research Institute/Centre for Global Health Research Siaya
        • physical_addressOff Kisumu-Busia Road, Kisumu
        • contact_detailsPhone number: +254 720 487 325 P.O.Box 1578- 40100,
        • contact_personDr. Patricia Ojwang or Dr. Simon Kariuki
        • site_capacity(null)
        • misc(null)
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id1760
        • application_id1448
        • county_id42
        • site_nameSite 1601:Kombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, Opposite Kombewa County Hospital, Kisumu Kenya
        • contact_detailsPhone Number: +254 733 811613 or +254733333530 22 P.O. Box 54-40100
        • contact_personDr. Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2024-07-30 03:39:20
        • modified2024-10-29 11:19:44
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1761
        • application_id1448
        • county_id42
        • site_nameAhero Clinical Trial Unit
        • physical_addressKisumu -Kenya
        • contact_detailsPhone Number: +254704616214 P.O.BOX 54-40100
        • contact_personDr. Bernhards Ogutu Dr. John Orimbo
        • site_capacity(null)
        • misc(null)
        • created2024-07-30 03:39:20
        • modified2024-10-29 11:19:44
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id766
        • application_id1448
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personDr. Yannick Brunner
        • addressNovartis Campus Lichtstrasse 35 CH-4056 Basel Switzerland
        • telephone_number0041 76 360 56 97
        • fax_number
        • cell_number0041 76 360 56 97
        • email_addressyannick.brunner@novartis.com
        • created2024-07-26 14:27:37
        • modified2024-10-29 11:19:44
  • 3(array)
    • Application(array)
      • id1422
      • user_id263
      • trial_status_id(null)
      • abstract_of_study<p align=\"left\">\n This will be a phase III, hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled, international, multicentre, non-inferiority trial. Participating women will be randomized to receive either intravenous HSC or oxytocin as the ‘first-line’ uterotonic for PPH treatment.</p>\n<p align=\"left\">\n The trial will be conducted across 20 tertiary level hospitals within the WHO “CHAMPION” Trial Network in Argentina, Kenya, India, Nigeria, Uganda, South Africa, and United Kingdom.</p>\n<p align=\"left\">\n Care providers will inform potentially eligible pregnant women about the trial during their antenatal care visits to the hospital. If a woman is seen for the first time during her admission to the hospital for childbirth, she will be provided information about the trial then. Women will be approached for participation in the trial if she is in early labour (<6cm cervical dilatation), her vital signs are normal, and she is not distressed at the moment of giving consent. Informed consent will be obtained from the woman before any trial-related procedures are carried out.</p>\n<p align=\"left\">\n Women having a vaginal birth who have been consented in early labour will receive an intramuscular (IM) prophylactic 100 µg dose of HSC for PPH prevention. Following the birth of the baby, a calibrated drape will be placed under the woman’s buttocks to measure blood loss following birth. Should atonic PPH based on a clinical diagnosis or blood loss estimation of 500 ml or more occur, the woman will be randomized to receive a saline intravenous (IV) infusion of HSC 100 µg or oxytocin 5 IU over 5 minutes. Following this treatment, women in the oxytocin arm (active control) will receive an additional 20 IU at a lower saline infusion rate over 4 hours in line with standard clinical practice, while women in HSC arm will receive an equivalent amount of saline infusion but with no additional uterotonic for the same period. Upon randomization, a new drape will be placed under the woman’s buttocks to measure further blood loss for 90 minutes. </p>\n<p align=\"left\">\n The investigational medicinal product (IMP) will be administered immediately following randomization of trial participants. Once the IMP has been administered to the woman as described above, the clinical staff will continue further PPH management in accordance with existing hospital PPH management protocol and WHO guidelines.</p>\n<p align=\"left\">\n All women will be followed up for 24 hours after randomization or until hospital discharge, whichever is soonest.</p>\n<p>\n The trial will be implemented with an internal safety sub-study. The first interim analysis will be conducted for an independent Data Safety Monitoring Committee (DSMC) to assess comparative safety of HSC versus oxytocin once the first 250 participants have been enrolled into the trial. </p>\n
      • study_title<p align=\"left\">\n <strong>Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial</strong></p>\n
      • laymans_summary<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Title: A Phase III Trial Comparing HSC and Oxytocin for Postpartum Hemorrhage Prevention</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Objective: This international, multicenter trial aims to compare the effectiveness and safety of intravenous HSC (an investigational uterotonic) with oxytocin (the current standard) for preventing postpartum hemorrhage (PPH).</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Study Design:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Type: Hospital-based, parallel, two-arm, individually-randomized, double-blind, active controlled.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Participants: Pregnant women at 20 tertiary level hospitals across Argentina, Kenya, India, Nigeria, Uganda, South Africa, and the United Kingdom.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Eligibility: Women in early labor with normal vital signs and no distress.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Randomization: Participants will receive either HSC or oxytocin as the first-line uterotonic.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Treatment Administration: Women having a vaginal birth will receive an intramuscular prophylactic dose of HSC. If atonic PPH occurs (500 ml blood loss or more), they will be randomized to receive either HSC or oxytocin via intravenous infusion.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n Follow-up: All women will be monitored for 24 hours after randomization or until hospital discharge.</p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n Safety Sub-Study:</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n An internal safety sub-study will assess the comparative safety of HSC versus oxytocin.</p>\n<p style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n The first interim analysis will occur after enrolling the first 250 participants.</p>\n<p lang=\"en-ZA\" style=\"margin:0in;font-family:Calibri;font-size:11.0pt;color:#2B3A42\">\n  </p>\n<p style=\"margin-top:9pt;margin-bottom:0pt;font-family:Calibri;font-size:11.0pt;\ncolor:#2B3A42\">\n This trial aims to improve PPH management and enhance maternal health outcomes.</p>\n<p style=\"padding: 0px; margin: 12px 0px 0px; word-break: break-word; font-size: 16px; line-height: var(--cib-type-body2-line-height); font-variation-settings: var(--cib-type-body2-font-variation-settings); color: rgb(17, 17, 17); font-family: -apple-system, Roboto, SegoeUI, "Segoe UI", "Helvetica Neue", Helvetica, "Microsoft YaHei", "Meiryo UI", Meiryo, "Arial Unicode MS", sans-serif; background-color: rgb(247, 247, 247);\">\n  </p>\n
      • short_titleWHO A66045
      • protocol_noECCT/24/08/04
      • version_no3.0
      • date_of_protocol03-09-2023
      • study_drugHeat-stable carbetocin (HSC)
      • disease_conditionpostpartum haemorrhage
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameHeat-stable carbetocin (HSC)
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameoxytocin
      • comparator_registeredyes
      • comparator_countriesMost countries including Kenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantDanielle Erasmus
      • declaration_date113-08-2024
      • declaration_principal_investigatorProf Zahida Qureshi
      • declaration_date213-08-2024
      • placebo_presentNo
      • study_objectives<p>\n The main aim of this trial is to generate evidence on the efficacy and safety of HSC compared to oxytocin when used as ‘first-line’ uterotonic for PPH treatment.</p>\n<p>\n The <strong>primary objective</strong> of this trial is to evaluate whether HSC is non-inferior to oxytocin for treatment of PPH in women who receive HSC for PPH prophylaxis, in the prevention of additional blood loss of 500 ml or more at 90 min following randomization.</p>\n<p>\n There are two hypotheses for the primary objective (one non-inferiority and one superiority hypotheses):</p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:601px;height:68px;\">\n <ol>\n <li>\n Intravenous (IV) HSC is non-inferior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more within a non-inferiority margin of 4% risk difference scale (primary hypothesis).</li>\n <li>\n Intravenous (IV) HSC is superior to IV oxytocin in terms of the proportion of women with PPH experiencing additional blood loss of 500 ml or more (secondary hypothesis). </li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n The <strong>secondary objectives</strong> are to (i) evaluate the comparative effects of HSC versus oxytocin on haemodynamic outcomes when used for PPH treatment in women receiving HSC for prophylaxis; and (ii) evaluate the cost-effectiveness of the PPH treatment with HSC compared to PPH treatment with oxytocin, if HSC is proven non-inferior.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Trial participants will be women who receive HSC for PPH prophylaxis and are diagnosed with PPH presumed to be due to uterine atony after a vaginal birth.</p>\n<p>\n To be eligible for inclusion into this trial, the women must fulfil <strong><u>all</u></strong> the following criteria:</p>\n<ul>\n <li>\n had a singleton pregnancy</li>\n <li>\n had a vaginal birth</li>\n <li>\n receive HSC (IM) for PPH prophylaxis</li>\n</ul>\n<ul>\n <li align=\"left\">\n have an indication to receive uterotonics for the treatment of PPH presumed due to uterine atony (clinically diagnosed, or measured vaginal blood loss of 500 ml or more in the first 60 minutes postpartum) and where known coagulopathy and retained placenta has been excluded as the cause of bleeding)</li>\n</ul>\n<ul>\n <li>\n provide written informed consent before any trial-related procedures are carried out</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Women are not eligible for this trial if they fulfill <strong><u>any</u></strong> of the following exclusion criteria:</p>\n<ul>\n <li align=\"left\">\n known history of allergy to oxytocin or HSC or any of their excipients.</li>\n <li align=\"left\">\n known serious coagulopathy, epilepsy, hepatic, renal, or cardiovascular disease.</li>\n <li align=\"left\">\n known intrauterine fetal death.</li>\n <li align=\"left\">\n birth that is considered an abortion according to local gestational age limit.</li>\n <li align=\"left\">\n have other clinically significant condition(s) that, in the opinion of the investigator could represent increased risk for the participation of the woman or interfere with the objectives of the study.</li>\n <li align=\"left\">\n a manual removal of placenta.</li>\n <li align=\"left\">\n a placenta in situ that has not been expelled or removed.</li>\n <li align=\"left\">\n known administration of any uterotonic for PPH treatment (e.g. prostaglandins, oxytocin, ergometrine) following PPH prophylaxis.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<h3>\n Primary end-points</h3>\n<p>\n The primary end-point is the proportion of women with additional vaginal blood loss of ≥ 500 ml at 90 minutes following randomization.</p>\n<p>\n <strong>Key Secondary end-points</strong></p>\n<ul>\n <li>\n The proportion of women with additional blood loss of ≥1000 ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics at 90 minutes following randomization</li>\n <li>\n The proportion of women with additional blood loss of ≥ 500 ml or receiving additional uterotonic(s) at 90 minutes following randomization</li>\n <li>\n The proportion of women having surgical procedures related to PPH (e.g. laparotomy for compressive sutures, artery ligation or hysterectomy, or uterine balloon tamponade) as at 24 hours following randomization.</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment up to 24 hours.  </li>\n</ul>\n<p>\n <strong>Other secondary end-points</strong></p>\n<ul>\n <li>\n Amount of blood loss in ml at 90 minutes following randomization</li>\n <li>\n The proportion of women receiving additional uterotonics as at 24 hours following randomization</li>\n <li>\n The proportion of women receiving blood transfusion products up to 24 hours following randomization</li>\n <li>\n The proportion of women admitted to intensive care unit as at 24 hours following randomization</li>\n <li>\n The proportion of maternal deaths</li>\n <li>\n The proportion of women with clinically defined coagulopathy as documented in medical records as at 24 hours following randomization</li>\n <li>\n The proportion of women breastfeeding as at 24 hours following randomization</li>\n</ul>\n<ul>\n <li>\n The proportion of women hypovolemic shock up to 24 hours following randomization</li>\n <li>\n The proportion and severity of adverse or serious adverse events up to 24 hours following randomization</li>\n <li>\n The proportion of women with composite outcome of maternal death or severe morbidity as at 24 hours following randomization into trial</li>\n</ul>\n<ul>\n <li>\n The proportion of women with any haemodynamic change requiring therapeutic intervention during the first 10 minutes of administering treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which requires treatment in the first 10 minutes after initiating treatment infusion</li>\n <li>\n Occurrence of clinically significant cardiac arrhythmia based on clinical judgement which results in cardiac arrest during the first 24 hours following randomization</li>\n</ul>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n 1. Qureshi Zahida, MBChB, Mmed Ob/Gyn</div>\n<div>\n Associate Professor of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi, Department of Obstetrics and Gynaecology</div>\n<div>\n P.O Box 19676-00202 KNH, Nairobi Kenya 0733605410</div>\n<div>\n zahida@qureshi.co.ke</div>\n<div>\n Principal Investigator: Responsible for the development and overall project oversight, science and overseeing all implementing team members in Kenya</div>\n<div>\n  </div>\n<div>\n 2. Osoti Alfred. MBChB, Mmed (Ob/Gyn), MPH, PHD</div>\n<div>\n Associate Professor, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 2343 00202 KNH Nairobi 0733886664</div>\n<div>\n alfredos@uw.edu</div>\n<div>\n Co-Investigator: Responsible for Human Resource, monitoring and evaluation and quality control during data collection period</div>\n<div>\n  </div>\n<div>\n 3. Gwako George. MBChB, Mmed (Ob/Gyn), PHD</div>\n<div>\n Lecturer, Department of Obstetrics and Gynaecology</div>\n<div>\n University of Nairobi</div>\n<div>\n P.O Box 4848-00200 Nairobi 0722992268</div>\n<div>\n gngwako@gmail.com</div>\n<div>\n Co-Investigator: Responsible for guiding study design, implementation and analysis</div>\n<div>\n  </div>\n<div>\n We are ideally suited to work with the Ministry of Health, County level 5 Hospitals. We have identified 3 sites that will serve as potential sites for this trial. These are;</div>\n<div>\n  </div>\n<div>\n Machakos County Referral Hospital – Lead Obstetrician Gynecologist Dr. Alice Isika</div>\n<div>\n Kiambu Level 5 Hospital – Lead Obstetrician Gynecologist Dr. Mary Maina</div>\n<div>\n Pumwani maternity Hospital – Lead Obstetrician Gynecologist Dr. Mandi Sura</div>\n<p>\n <strong>Machakos Level 5 Hospital</strong> is a public referral hospital located in Machakos County. It handles over 500 deliveries per month. The hospital offers a variety of services for outpatients (General Care, Dental Services, Pharmacy Services, Laboratory Services, Imaging Services, HIV/AIDS Prevention Treatment and Care, Maternal and Child Health, Eye Services, Nutrition Services) as well as inpatients (Medical ward/Surgical ward, Maternity Ward, Post Natal Ward, New Born Unit, Pediatric Ward, Operating Theatre, Inpatient gynaecology consultation, Physiotherapy). The hospital provides ANC to approximately 200 women each month. It has a 507-bed capacity with 57 newborn cots. There are 2 consultant obstetricians/gynaecologists, and 4 Medical Officers. It has an average of 350 deliveries in a month. The hospital has established referral networks with emergency transport availability.</p>\n<p>\n During the trial, skilled and adequately GCP trained individuals will be involved in the trial management. When the woman attends the delivery suite, a skilled health personnel in charge of caring women in labor at the hospital will provide sufficient information about the trial and, will request consent from the participant. Following birth of the baby, screening of the consented participants will be undertaken to ensure eligibility by a skilled and trained, member of research team. Eligibly participants will be randomized and  the member of the research team will conduct ongoing data collection safely and effectively.</p>\n<div>\n <strong>Kiambu Level 5 Hospital </strong>is a public health facility situated in Kiambu County. It serves a large population both urban and rural. The hospital serves as the referral center for catchment areas from nearby sub counties.. It has 45 beds dedicated to the maternity unit. The hospital provides Antenatal services to approximately 260 women per month. It has 2 Obstetrician gynaecologists, 3 Medical officers and 27 midwives. It handles approximately 700 deliveries per month. The preterm birth (<34 weeks) rate Is 7%. The preterm mortality rate is 45%. About 34% pregnant mothers are registered to ANC before 12 weeks of gestation.</div>\n<div>\n Available services include ultrasonography, tocolytic drugs, antenatal corticosteroids, caesarean sections and instrumental deliveries- Vacuum deliveries. It has a 46 bed capacity maternity ward with 22 midwives, 4 medical officers and 5 Obstetrician/Gynaecologists. There is piped oxygen and a 2 bed adult ICU, where a 3rd bed is created for Obstetric patients. The new born unit is a 50 bed capacity with 11 nurses and 4 paeditricians. There is no NICU. Basic resuscitation services are available including incubators, radiant heaters and piped oxygen. CPAP is available, however exogenous surfactant is not available.</div>\n<div>\n  </div>\n<div>\n <div>\n <strong>Pumwani Maternity Hospital </strong>is the largest maternity hospital situated in Nairobi County. The facility is managed by the County Government of Nairobi. It serves as the major referral centre for the county and beyond. The hospital provides comprehensive emergency obstetric and newborn care and has ultrasound services.</div>\n <div>\n The facility has 354 obstetrics bed capacity, 144 baby cots and 2 operating theatres. There are 4 Obstetrician gynaecologists, 4 Medical Officers and 25 Midwives. Average number of deliveries per month is 1000 with approximately 70-100 per day. The facility has well equipped laboratory and functional blood transfusion services.</div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Sites that participated in the CHAMPION study and are part of the WHO CHAMPION Trial network will participate in this study. If licensed, HSC would have most benefit in settings where temperature control uterotonics cannot be guaranteed. Switzerland would not meet these criteria. That said, as a representative of a HIC we have selected the UK to ensure the diversity of settings. The trial site in the UK previously participated in the CHAMPION Trial and has local expertise in PPH treatment trials.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n South Africa: SAHPRA approval dated 22 Jan 2024- 2 Sites</p>\n<p>\n  </p>\n<p>\n UK – MHRA approval date 05Mar2024 – 1 site</p>\n<p>\n  </p>\n<p>\n ARG – ANMAT approval date 30 May 2024 – 2 sites</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration54 months according to the following schedules: 12 months for trial preparation; 30 months for trial enrolment; and 12 months for final analysis, trial publication and dissemination of results.
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherYes
      • design_controlled_specifyActive controlled, non-inferiority trial
      • design_controlled_comparatorOxytocin
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states7
      • number_of_sites3
      • multi_country_listArgentina, India, Kenya, Nigeria, South Africa, Uganda, and United Kingdom
      • data_monitoring_committeeYes
      • total_enrolment_per_siteMachakos county hospital: we estimate around 393 women could be randomized across 30 months. \nPumwani maternity hospital: we estimate around 301 women could be randomized across 30 months\nKiambu level five hospital: we estimate around 376 women could be randomized across 30 months.
      • total_participants_worldwide6200
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameZahida
      • investigator1_middle_name
      • investigator1_family_nameQureshi
      • investigator1_qualificationMBBS, Mmed, Ob/Gyn
      • investigator1_professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
      • investigator1_telephone+254 733 605 410
      • investigator1_emailzahida@qureshi.co.ke
      • organisations_transferred_Yes
      • number_participants1000
      • notification
      • approval_date06-02-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-08-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer queries have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-02-06 12:45:38
      • created2024-06-18 16:21:02
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1079
        • application_id1422
        • given_nameZahida
        • middle_name
        • family_nameQureshi
        • qualificationMBBS, Mmed, Ob/Gyn
        • professional_addressPO Box 19676-00202 Kenyatta National Hospital Nairobi Kenya
        • telephone+254 733 605 410
        • emailzahida@qureshi.co.ke
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
    • SiteDetail(array)
      • 0(array)
        • id1725
        • application_id1422
        • county_id16
        • site_name Machakos county hospital
        • physical_addressP.O Box 19-90100 Machakos
        • contact_details+254721404445
        • contact_personDr. Alice Isika
        • site_capacity(null)
        • misc(null)
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 1(array)
        • id1726
        • application_id1422
        • county_id47
        • site_namePumwani maternity hospital
        • physical_addressP. O Box 42849-00100 Nairobi
        • contact_details+254722775150
        • contact_personDr. Mandeep Sura
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:07:14
        • modified2024-08-16 14:40:55
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1727
        • application_id1422
        • county_id22
        • site_nameKiambu level 5 hospital
        • physical_addressP.O Box 39-00900 Kiambu
        • contact_details +254722327304
        • contact_personDr. Mary Maina
        • site_capacity(null)
        • misc(null)
        • created2024-06-19 16:08:29
        • modified2024-08-16 14:40:55
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id755
        • application_id1422
        • sponsorWHO
        • sponsor_typeIndustry
        • contact_personMariana Widmer
        • addressAvenue Appia 20 1211 Geneva 27 Switzerland
        • telephone_number+41227914323
        • fax_number
        • cell_number+41227914323
        • email_addresswidmerm@who.int
        • created2024-06-18 16:34:25
        • modified2024-08-16 14:40:55
  • 4(array)
    • Application(array)
      • id1452
      • user_id693
      • trial_status_id(null)
      • abstract_of_study<div>\n <strong>BACKGROUND</strong></div>\n<div>\n Chronic Obstructive Pulmonary Disease (COPD) was the third leading cause of death worldwide in 2019, accounting for approximately 6% of all deaths. Chronic obstructive pulmonary disease is distinguished by persistent respiratory symptoms and restricted airflow due to airway and/or alveolar abnormalities. COPD exacerbation, defined as an acute worsening of respiratory symptoms requiring additional therapy, is one of the key indicators of disease activity. Chronic obstructive pulmonary disease exacerbations represent the largest burden in terms of healthcare utilization, patient morbidity, and risk of mortality. Current COPD treatment options include non-pharmacologic and pharmacologic measures, which are insufficient to prevent symptoms or slow disease progression. Other safe and efficacious treatment modalities are desperately needed.</div>\n<div>\n  </div>\n<div>\n <strong>STUDY RATIONALE</strong></div>\n<div>\n The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).</div>\n<div>\n  </div>\n<div>\n <strong>OBJECTIVES AND ENDPOINTS</strong></div>\n<div>\n Primary Objective:</div>\n<div>\n To evaluate the long-term safety of astegolimab</div>\n<div>\n Corresponding Endpoint:</div>\n<div>\n Incidence and severity of adverse events, with severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n<div>\n  </div>\n<div>\n <strong>OVERALL DESIGN AND STUDY POPULATION</strong></div>\n<div>\n This is a Phase III multicenter, single group open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab (RO7187807) in combination with standard of care (SOC). The study population will be adults aged 40-90 years (at time of consent in parent study), with Chronic obstructive pulmonary disease (COPD). Approximately 2,000 participants with COPD are expected to be enrolled globally, with the sites targeting approximately five patients with COPD who have completed the 52-week treatment period in Study GB44332 and fulfill the eligibility criteria for the OLE, for enrolment.</div>\n<div>\n Patients who have discontinued treatment in the parent study will not be eligible to enroll into the OLE.</div>\n
      • study_title<p>\n A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE</p>\n
      • laymans_summary<div>\n Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that mostly affects older people who have smoked cigarettes in the past or have been exposed to or breathed in other harmful particles for a long time, like smoke from biomass fuels. It is the third leading cause of death worldwide, and the number of people who have it is growing around the world. Even though smoking cigarettes has always been the biggest risk factor for COPD, there is clear evidence that non-smokers can also get the disease.</div>\n<div>\n The risk of COPD goes up with age, and most people with COPD are 40 years old or older. Men are more likely to have COPD than women. COPD is a disease that affects different people in different ways and gets worse over time. The progression of the disease is strongly linked to thickening and narrowing of the airway walls, reducing the lungs' ability to stretch and reducing airflow. Patients withn COPD will present with some of the following signs and symptoms; Cough, shortness of breath and production of a thick mixture of saliva and mucus (sputum) coughed from the airways.</div>\n<div>\n As symptoms worsen and the disease progresses, the likelihood of death increases. Current existing treatments have been unable to significantly slow down the progression of the disease and prevent episodes of worsened symptoms. New, more effective ways to treat patients that will relieve their symptoms and change the course of the disease are urgently needed.</div>\n<div>\n Astegolimab is a drug that is under investigation for the treatment of patients with COPD. It has been noted to potentially prevent the worsening of symptoms and improve lung function and quality of life for the respective patient populations. This study will look at the long term safety and how well astegolimab works in people with COPD who have used the drug for 1 year in a previous study.</div>\n<div>\n If found to be safe and efficacious, astegolimab will be recommended for market registration to make it commercially available locally so that people with COPD can have access to the drug in the market, subject to approval by relevant health authorities.</div>\n
      • short_titleALNASA
      • protocol_noECCT/24/08/03
      • version_no2
      • date_of_protocol03-04-2023
      • study_drugAstegolimab (RO7187807)
      • disease_conditionChronic Obstructive Pulmonary Disease (COPD)
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_nameAstegolimab (RO7187807)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantKarabo Tsoku
      • declaration_date113-08-2024
      • declaration_principal_investigatorProf Videlis Nduba
      • declaration_date213-08-2024
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary Objective</strong></div>\n<ul>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n</ul>\n<div>\n <strong>Exploratory Objectives</strong></div>\n<ul>\n <li>\n To evaluate the efficacy of astegolimab</li>\n <li>\n To evaluate health status utility scores of participants treated with astegolimab</li>\n <li>\n To evaluate the long-term safety of astegolimab</li>\n <li>\n To characterize the PK profile of astegolimab</li>\n <li>\n To evaluate the immune response to astegolimab</li>\n <li>\n To identify and/or evaluate biomarkers that are predictive of response to astegolimab (i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers), can provide evidence of astegolimab activity (i.e., PD biomarkers), or can increase the knowledge and understanding of disease biology and drug safety or pharmacokinetics</li>\n</ul>\n
      • principal_inclusion_criteria<ul>\n <li>\n Signed Informed Consent Form.</li>\n <li>\n Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.</li>\n <li>\n Completion of the 52-week treatment period in either Study GB43311 or Study GB44332. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.</li>\n <li>\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached apostmenopausal state (at least12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mü llerian agenesis). The definition of childbearingpotential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Withdrawal of consent and/or premature discontinuation from parent study</li>\n <li>\n Any permanent discontinuation of study drug in parent study</li>\n <li>\n Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment</li>\n <li>\n Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.</li>\n <li>\n Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study</li>\n <li>\n Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study</li>\n</ul>\n<div>\n <ul>\n <li>\n Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) at the time of study entry</li>\n <li>\n Initiation of treatment that is considered palliative (e.g., for life expectancy < 12 months) since enrolling in the parent study</li>\n <li>\n History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab</li>\n </ul>\n <div>\n <ul>\n <li>\n Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study</li>\n </ul>\n <div>\n <ul>\n <li>\n Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study</li>\n </ul>\n <div>\n <ul>\n <li>\n Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study</li>\n <li>\n <div>\n QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms</div>\n </li>\n </ul>\n </div>\n </div>\n </div>\n</div>\n
      • primary_end_points<div>\n <strong>Primary Objective Endpoints</strong></div>\n<div>\n Incidence and severity of all adverse events, including SAEs, AESIs and AEs leading to death or discontinuation. Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (HHS 2017) (hereafter referred to as the DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site has a network of health facilities and communities  that collaborate with KEMRI in clinical trials; the site reaches out to these stakeholders to refer eligible participants.</p>\n<p>\n The KEMRI-Mtwapa Clinical Research site is a fully equipped trial site. The site has a fully equipped laboratory with the ability to perform basic clinical tests including full blood count, renal and liver function tests and other chemistry tests. It has been equipped with a sponsor-provided Spirometer with ECG performance capability. Study staff have been trained on spirometry the use of the ECG component.</p>\n<p>\n The site has access to appropriate safety measures and has highly capable clinical site personnel experienced in conducting clinical trials. Site staff include the principal investigator, 4 Sub-PIs, 1 medical officer, 2 clinical officers, 1 administrator and 4 community health workers. The site is taking part in the parent 52-week placebo-controlled Phase III (GB44332) astegolimab study, a prerequisite for this  open-label extension (OLE) study. </p>\n
      • other_details_explanation<p>\n Switzerland is the host country and we already received approval in Switzerland. CEC and RA approvals were received on 17-Sep-2024</p>\n
      • other_details_regulatory_notapproved<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:21px;\">\n <p>\n <strong>I</strong><strong>NDIA                                                                                DATE SUBMITTED</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 30-Apr-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>P</strong><strong>HILIPPINES</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 18-Apr-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>C</strong><strong>HINA</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n To be submitted</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>B</strong><strong>RAZIL</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 16-May-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>K</strong><strong>ENYA</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 13-Jun-2024 (first site)</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>P</strong><strong>ERU</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 15-Mar-2024 (first site)</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n AUSTRIA</td>\n <td style=\"width:141px;height:18px;\">\n 25Jun2024</td>\n <td style=\"width:161px;height:18px;\">\n Pending expected by 24-Sep2024</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:37px;\">\n <p>\n <strong>List of Competent Authorities inside the EU/EEA to which the Application has been Approved </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Member State </strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n BELGIUM (11 sites), BULGARIA(25 sites), CZECH REPUBLIC (10sites), DENMARK (6sites), FRANCE (7sites), GERMANY (30sites), NETHERLANDS (5 sites), POLAND (36sites) , ROMANIA (4 sites), SPAIN (16sites), SWEDEN (6sites)</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n Approved, 2-Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:107px;\">\n <p>\n <strong>EU</strong> <strong>CTR</strong></p>\n <p>\n GREECE, HUNGARY, ITALY, LATVIA</p>\n </td>\n <td style=\"width:141px;height:107px;\">\n <p>\n 25-Jun-2024</p>\n </td>\n <td style=\"width:161px;height:107px;\">\n <p>\n  </p>\n <p>\n GREECE – Approved, 18-Sep2024</p>\n <p>\n HUNGARY - Approved, 03-Sep2024</p>\n <p>\n ITALY - Approved, 16-Sep2024</p>\n <p>\n LATVIA - Approved, 17-Sep2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong>List of Competent Authorities outside the EU/EEA to which the Application has been approved</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED KINGDOM (17sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 25-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 31-Aug2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>ARGENTINA (40sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 22-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 11-Sep-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>AUSTRALIA (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 02-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 15-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>CHILE (10sites)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 18-Oct-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 20-Dec2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:19px;\">\n <p>\n <strong>HONG KONG (1 site)</strong></p>\n </td>\n <td style=\"width:141px;height:19px;\">\n  </td>\n <td style=\"width:161px;height:19px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 24-Aug-2023</p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 21-Nov2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:21px;\">\n <p>\n <strong>MEXICO (4 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:21px;\">\n  </td>\n <td style=\"width:161px;height:21px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n 28-Jul-2023 </p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n Approved, 6-Nov-2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>CANADA (14sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 24-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 23-Jun2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>NEW ZEALAND (7sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 14-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 7-Jul2023</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:589px;\" width=\"589\">\n <tbody>\n <tr>\n <td style=\"width:287px;height:37px;\">\n <p>\n <strong>Country</strong></p>\n </td>\n <td style=\"width:141px;height:37px;\">\n <p>\n <strong>Date Submitted</strong></p>\n </td>\n <td style=\"width:161px;height:37px;\">\n <p>\n <strong>Outcome Date</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH AFRICA (15sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 30-May-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved,12-Sep2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>SOUTH KOREA (13sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:36px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:36px;\">\n <p>\n 9-Jun-2023</p>\n </td>\n <td style=\"width:161px;height:36px;\">\n <p>\n Approved, 10Oct2023</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>UNITED STATES OF AMERICA (74sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n  </td>\n <td style=\"width:161px;height:18px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 13-Feb-2023</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved </p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TAIWAN (6sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,28-May2024</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:589px;height:18px;\">\n <p>\n <strong>TURKEY (3sites)</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 20-Mar-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved，9 Aug2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>S</strong><strong>WITZERLAND (1site)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 29-Jul-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n Approved,16-Sep2024</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n <strong>T</strong><strong>HAILAND (2 sites)</strong></p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:287px;height:18px;\">\n <p>\n Competent Authority</p>\n </td>\n <td style=\"width:141px;height:18px;\">\n <p>\n 21-May-2024</p>\n </td>\n <td style=\"width:161px;height:18px;\">\n <p>\n 25-Jun2024</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable. None of the Regulatory Authorities or Ethics Committees have rejected this trial.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_durationStudy participation for each individual is expected to range from 1 day to more than 51 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states39
      • number_of_sitesApproximately 5 sites
      • multi_country_listAUSTRALIA, CHINA,HONG KONG,INDIA,JAPAN, NEW ZEALAND, PHILIPPINES, SOUTH KOREA, TAIWAN, THAILAND, BRAZIL, ARGENTINA, CANADA, CHILE, MEXICO, PERU, AUSTRIA, BELGIUM, BULGARIA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, GREECE, HUNGARY, ITALY, LATVIA, NETHERLANDS, POLAND, ROMANIA, SPAIN, SWEDEN, ISRAEL, KENYA, SOUTH AFRICA, SWITZERLAND, TURKEY, UNITED KINGDOM, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site 5 participants for this site.
      • total_participants_worldwideApproximately 2000 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsApproximately 18 participants
      • notification
      • approval_date21-12-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted13-08-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted13-08-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonResponse to review comments satisfactory
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-05-07 15:33:46
      • created2024-08-06 09:58:32
      • total_sites5
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1127
        • application_id1452
        • given_nameMary Inziani
        • middle_name
        • family_nameMatilu
        • qualificationMedical Doctor
        • professional_addressKEMRI-Mtwapa Clinical Annex P.O. Box 428-80108, Mtwapa
        • telephone+254722523370
        • emailinzianimatilu@gmail.com
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
    • SiteDetail(array)
      • 0(array)
        • id1764
        • application_id1452
        • county_id3
        • site_nameKEMRI-Mtwapa Clinical Annex
        • physical_addressP.O. Box 428-80108, Mtwapa
        • contact_details+254722523370
        • contact_personDr Mary Matilu
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
        • County(array)
          • id3
          • county_nameKilifi
          • created2012-05-31 16:15:49
          • modified2012-05-31 16:15:49
      • 1(array)
        • id1765
        • application_id1452
        • county_id47
        • site_nameCenter for Research In Tropical Medicine and Community Development
        • physical_addressP.O. Box 6387, Thika, Kenya
        • contact_details+254722425613
        • contact_personDr Jesse Gitaka
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:06:27
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1766
        • application_id1452
        • county_id16
        • site_nameClinical Research Health Network (CREA-N)
        • physical_addressMachakos Level 5 Hospital Site P.O. Box 19 -90100 Machakos Kenya
        • contact_details+254115021107
        • contact_personDr Jacqueline Mirera
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id16
          • county_nameMachakos
          • created2012-06-15 10:23:55
          • modified2012-06-15 10:23:55
      • 3(array)
        • id1767
        • application_id1452
        • county_id47
        • site_nameUniversity of Nairobi Clinical Research Centre
        • physical_addressProf Mungai Road Off Wasawo Drive Off Riverside Drive Chiromo Campus University Of Nairobi P.O. Box 19676 00202 Nairobi Kenya
        • contact_details+254 707028067
        • contact_personDr Teresa Kinyari
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1768
        • application_id1452
        • county_id47
        • site_nameKEMRI-CRDR Clinical Research Annex
        • physical_addressKenyatta National Hospital Grounds, Off Hospital Road, Behind Government Chemist, P.O. BOX 47855-00100, Nairobi, Kenya
        • contact_details+254790484654
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2024-08-06 11:09:20
        • modified2024-11-11 13:04:51
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id770
        • application_id1452
        • sponsorF. Hoffmann-La Roche Ltd
        • sponsor_typeIndustry
        • contact_personHeather Schofield
        • addressGrenzacherstrasse 124, 4070 Basel, Switzerland
        • telephone_number+ 41 6168 81111
        • fax_number
        • cell_number+416-930-1484
        • email_addressglobal.eudract@roche.com
        • created2024-08-06 10:54:13
        • modified2024-11-11 13:04:51
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php