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  • 1Recruiting
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    • Application(array)
      • id993
      • user_id676
      • trial_status_id(null)
      • abstract_of_study<div>\n Background</div>\n<div>\n Tuberculosis (TB) is the leading cause of death in HIV-positive individuals. Underdiagnosis of TB is a principal barrier to combatting the disease. In resource-limited settings, molecular diagnoses such as Xpert MTB/RIF are still not widely available and sputum samples can be difficult to produce, especially for very ill HIV-positive patients.</div>\n<div>\n  </div>\n<div>\n The Fujifilm SILVAMP TB LAM (FujiLAM; Fujifilm, Tokyo, Japan) is a novel (not commercialised) urine107 based point-of-care assay to diagnose TB in HIV-positive patients. A first study using urine frozen samples has reported a higher sensitivity of this test over the currently commercialised Alere Determine TB LAM Ag assay (AlereLAM).</div>\n<div>\n  </div>\n<div>\n At the time of the study preparations, a pandemic caused by a new coronavirus (SARS-CoV-2), is ongoing. Symptoms of coronavirus disease (CoViD-19) are similar to those of TB and people with suppressed immune systems may be particularly vulnerable to this disease.</div>\n<div>\n  </div>\n<div>\n Objectives</div>\n<div>\n The aim of this study is to investigate the diagnostic performance of FujiLAM in ambulatory HIV positive patients from fresh urine samples.</div>\n<div>\n  </div>\n<div>\n Primary objective: To assess the sensitivity of FujiLAM among patients with microbiological confirmed TB in two groups of HIV-positive patients: 1) ambulatory adult HIV-positive patients with signs and symptoms of TB regardless of their CD4 count (Group 1), and 2) ambulatory adult patients with advanced HIV disease and no signs and symptoms of TB (Group 2).</div>\n<div>\n  </div>\n<div>\n Secondary objectives: To assess the sensitivity of FujiLAM and AlereLAM in urine by level of CD4 among patients with microbiologically confirmed TB and among patients with probable TB or microbiologically confirmed TB, the diagnostic performance of algorithms including FujiLAM, the mortality at 6 months according to the FujiLAM result and the feasibility of using the FujiLAM at point-of-care and the test acceptability by test users, clinic managers and patients. To assess the prevalence of CoViD-19 among HIV-positive ambulatory patients with symptoms of TB, to describe the clinical features, the severity and the outcomes of the patients diagnosed with CoViD-19, and the proportion of patients co-infected with CoViD-19 and TB, to assess the proportion of HIV-positive patients exposed to SARS-CoV-2</div>\n<div>\n  </div>\n<div>\n Methods</div>\n<div>\n This prospective diagnostic study, will include two groups of ambulatory adult patients: 1) HIV positive patients with signs and symptoms of TB (Group 1), and 2) patients with advanced HIV disease (CD4 < 200 cells/μL or WHO Stage III/IV) and no signs and symptoms of TB (Group 2). In addition, a mix-methods approach will be used to assess the feasibility and acceptability of the test. Quantitative and qualitative methods using an exploratory design will be used for this purpose.</div>\n<div>\n  </div>\n<div>\n The study will take place in Homa Bay County Hospital in Kenya. This study is part of a multicentric study that includes other sites: the Mbarara Regional Reference Hospital in Uganda, Alto Maé Health Centre in Mozambique, and Eshowe Gateway Clinic (EGC) in Eshowe, KwaZulu-Natal, South Africa.</div>\n<div>\n  </div>\n<div>\n <div>\n Patients will be assessed for signs and symptoms of TB (cough, fever, weight loss, 138 night sweats). HIV139</div>\n <div>\n positive patients with signs and symptoms of TB and fulfilling other eligibility criteria will be invited to participate in the study as Group 1. HIV-positive patients with no signs and symptoms of TB, and with CD4 <200 cells/μL within the month prior to the consultation or in clinical Stage III/IV at the time of the consultation, and fulfilling other eligibility criteria will be invited to participate in the study as Group 2. All eligible patients will be proposed to sign an informed consent. For patients with no signs and symptoms of TB who are on clinical stage I/II and do not have a CD4 result within the month prior to the consultation, CD4 monitoring will be done by the study. In such case, patients will sign an informed consent before screening for eligibility.</div>\n <div>\n  </div>\n <div>\n Patients will receive a clinical exam, FujiLAM and AlereLAM in urine, Xpert MTB/RIF and MTB culture on sputum samples, and chest X-ray. The treating clinician will decide to treat for TB or not according to the clinical exam and the test results available except the Fuji LAM test results. Patients with signs and symptoms of TB not started on TB treatment will be re-assessed at a second consultation no later than 7 days (earlier if laboratory results are available earlier or if the patient requires a consultation earlier). In some cases a third consultation may be needed due to the clinical situation or to the delay in receiving some test results. Patient’s outcomes whether on TB treatment or not, will be assessed at 3 months and 6 months.</div>\n <div>\n  </div>\n <div>\n In addition to the TB investigations, patients with signs and symptoms of TB will be proposed optional CoViD-19 testing using conventional PCR or point-of-care PCR (GeneXpert SARS-CoV-2) at the first consultation and during follow-up if COVID-19 symptoms arise. Patients diagnosed with Covid-19 will be referred to the Homa Bay Ministry of Health Covid-19 centre for their management. All patients (symptomatic and asymptomatic) will be also proposed optional SARS-CoV-2 antibody testing at the first and last consultation.</div>\n <div>\n  </div>\n <div>\n The primary endpoint will be the sensitivity of FujiLAM calculated as the proportion of patients with a positive test result among patients with microbiological confirmed TB.</div>\n <div>\n  </div>\n <div>\n Secondary endpoints will be:</div>\n <div>\n - Sensitivity of FujijLAM and AlereLAM by level of CD4 among patients with microbiologically confirmed TB and among patients with probable TB or microbiologically confirmed TB</div>\n <div>\n - Specificity, positive and negative predictive values of FujiLAM</div>\n <div>\n - Diagnostic performance of algorithms combining AlereLAM or FujiLAM in urine with Xpert MTB/RIF in sputum</div>\n <div>\n - Median time to FujiLAM, AlereLAM and Xpert MTB/RIF test results</div>\n <div>\n - Mortality at 6 months according to the FujiLAM result.</div>\n <div>\n - Feasibility and acceptability of the FujiLAM test at point of care by test users, managers and patients.</div>\n <div>\n - Proportion of TB symptomatic patients diagnosed with CoViD-19 overall, by TB diagnosis, by severity of disease and by outcome.</div>\n <div>\n - Proportion of patients exposed to SARS-CoV-2.</div>\n <div>\n  </div>\n <div>\n A total of 200 HIV-positive patients with signs and symptoms of TB (Group 1) and 250 HIV-positive patients with no signs and symptoms of TB and CD4<200 or in stage III/IV (Group 2) will be recruited in Homa Bay.</div>\n <div>\n  </div>\n <div>\n <div>\n Patients’ informed consent will be obtained before enrolment in the study. The study 180 protocol, the information sheets, the consent forms and any other relevant documents will be submitted for approval to the National Ethics Committees in each country where the study will be conducted and to Médecins Sans Frontières (MSF) Ethics Review Board.</div>\n <div>\n  </div>\n <div>\n Expected results</div>\n <div>\n This research study would be among the first to provide evidence through a prospective study on the performance of FujiLAM, a novel point-of-care test to diagnose TB in HIV-positive patients in programmatic conditions. If the diagnostic performance of this test is proven to be good, the use of the test would allow rapid TB diagnosis and would potentially decrease mortality in HIV-positive patients.</div>\n <div>\n  </div>\n <div>\n The study will also inform WHO and the international scientific community on the diagnostic performance and other implementation aspects of using the test. The study will also provide additional evidence on CoViD-19 among HIV-positive patients.</div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<div>\n Diagnostic performance of a novel lipoarabinomannan test (FujiLAM) to detect tuberculosis in HIV-positive patients in Kenya</div>\n
      • laymans_summary<div>\n Tuberculosis (TB) is the leading cause of death among individuals living with HIV. Many cases of TB are missed each year for various reasons including lack of appropriate tools for the diagnosis of tuberculosis in specific populations at risk. This hinders the efforts to combat the disease. A test called the GeneXpert is a standard in the diagnosis of TB in Kenya and many similar settings. The test looks for the genetic material of the bacteria causing tuberculosis and requires individuals with suspected tuberculosis to produce phlegm for testing. While this test shows good performance, it is not always available and some categories of individuals such as HIV patients who are very sick are unable to cough up the phlegm required for testing.</div>\n<div>\n  </div>\n<div>\n The purpose of this study is to assess the performance of a new test called the Fujifilm SILVAMP TB LAM or simply the Fuji-LAM test. The Fuji-LAM test is a test that can be done on urine to look for specific proteins that are produced by the bacteria that causes tuberculosis. This test offers an advantage over the tests that are based on phlegm because most patients can produce urine for testing even when they are very sick. Additionally, this test does not require a complex laboratory set up and it can therefore be used by health workers as they interact with the patient. This study will also look at how the new test compares with an existing test - AlereLAM - that is based on similar technology. Initial laboratory-based studies conducted on frozen urine samples show that the new test has better performance than the existing test. This study is different from the first studies because it is being conducted in real life settings rather than in a laboratory.</div>\n<div>\n  </div>\n<div>\n Tuberculosis shares certain symptoms with the ongoing COVID-19 pandemic and patients who have both diseases may experience worse outcomes. Because it might be difficult to accurately differentiate between early Tuberculosis and COVID19, individuals who agree to participate will be also offered COVID 19 tests to help distinguish between the two diseases and offer those with COVID19 appropriate treatment. This will also help us understand how COVID19 is affecting patients living with HIV and TB.</div>\n<div>\n  </div>\n<div>\n The study will be conducted at the Homa Bay County Hospital in Kenya. Individuals living with HIV with and without signs and symptoms of TB will be invited to take part. Individuals who agree to participate will be seen by the health workers in the study and will provide samples for testing using the FujiLAM test and other standard tests used to investigate individuals for suspected tuberculosis. We are also conducting similar studies in other African countries including Uganda, Mozambique and South Africa. This will enable us to assess the performance of the test in diverse settings.</div>\n<div>\n  </div>\n<div>\n Should the study find that the performance of the Fuji-LAM test is good, it will make recommendations on the use of the test. The use of the test may allow faster identification of TB particularly among persons living with HIV. This faster identification will allow earlier treatment and likely to reduce the deaths that are associated with TB among persons living with HIV.</div>\n
      • short_titleFujiLAM Study
      • protocol_noECCT/21/04/01
      • version_nov2.3
      • date_of_protocol23-09-2020
      • study_drugNot applicable
      • disease_conditionTuberculosis
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameFUJI LAM Test Kit
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresswansiste07@gmail.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_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample0
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • 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_applicantDr. Stephen Sitima Wanjala
      • declaration_date129-03-2021
      • declaration_principal_investigatorDr Stephen Sitima Wanjala
      • declaration_date229-03-2021
      • placebo_presentNo
      • study_objectives<p>\n <strong>Objectives</strong></p>\n<p>\n The aim of this study is to investigate the diagnostic performance of FujiLAM in ambulatory HIV290<br />\n positive patients.</p>\n<p>\n <strong>Primary objective</strong><br />\n To assess the sensitivity of FujiLAM among patients with microbiological confirmed TB in two groups of HIV-positive patients: 1) in ambulatory HIV-positive patients with signs and symptoms of TB regardless of their CD4 count (Group 1), and 2) in ambulatory patients with advanced HIV disease (CD4 below 200 cells/μL or WHO stage III/IV) and no signs and symptoms of TB (Group 2).</p>\n<p>\n <strong>Secondary objectives</strong><br />\n â‚‹ To assess the sensitivity of FujiLAM at different levels of CD4 count.<br />\n â‚‹ To assess the sensitivity of AlereLAM in urine and compare the diagnostic sensitivity of FujiLAM with AlereLAM.<br />\n â‚‹ To assess the diagnostic performance in the 24 hours following the first visit, of diagnostic algorithms combining FujiLAM or AlereLAM in urine with Xpert MTB/RIF in sputum.<br />\n â‚‹ To assess the specificity and predictive values of FujiLAM.<br />\n â‚‹ To compare FujiLAM and Xpert in urine results in patients with no sputum sample available.<br />\n â‚‹ To assess the time to FujiLAM, AlereLAM and Xpert MTB/RIF test results.<br />\n â‚‹ To assess the mortality at 6 months according to the FujiLAM result.<br />\n â‚‹ To assess the FujiLAM test inter-reader agreement<br />\n â‚‹ To assess the feasibility of using FujiLAM at point-of-care, and the test acceptability by test users, managers and patients.<br />\n â‚‹ To assess the prevalence of CoViD-19 in HIV-positive ambulatory patients with symptoms of TB, to describe the clinical features, the severity and the outcomes of the patients diagnosed with CoViD-19 and the proportion of patients co-infected with CoViD-19 and TB, to assess the proportion of HIV-positive patients exposed to SARS-CoV-2.</p>\n
      • principal_inclusion_criteria<p>\n Inclusion criteria<br />\n - 15 years of age or older<br />\n - HIV-positive<br />\n <strong>Group 1:</strong> At least one symptom of TB<br />\n <strong>Group 2</strong>: Advanced HIV disease (CD4 count less than 200cell/μl or clinical stage III/IV)<br />\n                AND No signs and symptoms of TB</p>\n<p>\n Signature of the informed consent for both groups</p>\n
      • principal_exclusion_criteria<p>\n Below 15 years</p>\n<p>\n Intake of anti-tuberculosis drugs for more than 5 days in the month prior to the consultation except preventive TB treatment.</p>\n
      • primary_end_points<p>\n Proportion of patients with a positive FujiLAM result among patients with microbiologically confirmed TB in ambulatory HIV-positive patients with signs and symptoms of TB (Group 1) and ambulatory HIV-positive patients with advanced HIV disease and no signs and symptoms of TB (Group 2).</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • 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_other1
      • trial_other_specifyDiagnostic Study
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:32px;\">\n <p>\n <strong>No</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Name</strong></p>\n </td>\n <td style=\"width:185px;\">\n <p>\n <strong>Qualification</strong></p>\n </td>\n <td style=\"width:164px;\">\n <p>\n <strong>Role/Experience</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 1</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Milcah Akinyi</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n BsN</p>\n <p>\n APGD_CR,MSc HM</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study coordinator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 2</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dalmas Ochiel</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Registered clinical Officer</p>\n <p>\n Bsc Public Health</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study clinician</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 3</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Barnabas Ogere</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Registered Clinical Officer</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study clinician</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 4</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Polycarp Oyoo</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Registered Nurse</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study Nurse</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 5</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Eve Dorcas Awino</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Registered Nurse</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study Nurse</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 6</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Irene Akoth</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Study lab technician</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 7</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Lucy Nyadoya Were</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Diploma IT</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Data Entry Clerk</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:32px;\">\n <p>\n 8</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Beryl Akinyi</p>\n </td>\n <td style=\"width:185px;\">\n <p>\n Diploma Social Work & Community Development</p>\n </td>\n <td style=\"width:164px;\">\n <p>\n Community mobiliser / Tracer</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The primary objective of the study is to evaluate the performence of the FujiLAM test in comparison to known alternatives(Alere LAM, Culture). Kenya and the other countries included in the study deemed appropriate because of the high prevalence of HIV and TB with a significant proportion of patients having advanced HIV. Previous studies have shown that LAM based technology is best suited for advanced HIV patients. In light of this, the countries were chosen because, if successfull, the patients who are most likely to benefit from the diagnostic tool being evaluted will come from high HIV/TB burden countries. </p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Medecines Sans Frontieres IRB , October 2019</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted
      • estimated_duration24 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
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      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaHomabay County Teaching and Referral Hospital
      • single_site_physical_addressHomabay Town Kenya
      • single_site_contact_personDr. Stephen Wanjala
      • single_site_telephone0720284862
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listUganda - Mbarara Teaching and Referral Hospital\nMozambique - Alto Maé Health Centre\nSouth Africa - Eshowe Gateway Clinic, KwaZulu Natal Province
      • data_monitoring_committeeNo
      • total_enrolment_per_site450 patients at Homabay County and Referral Hospital
      • total_participants_worldwide1870
      • 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_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_nameSitima
      • investigator1_family_nameWanjala
      • investigator1_qualificationMBChB, MSc Health Economics and Policy, MBA
      • investigator1_professional_addressP. O. Box 21340 - 00100
      • investigator1_telephone0720284862
      • investigator1_emailwansiste07@gmail.com
      • organisations_transferred_No
      • number_participantsA total of 450 patients will be recruited in Homabay Kenya. 200 of these will be HIV-positive patients with signs and symptoms of TB (Group 1) and 250 will be HIV-positive patients with no signs and symptoms of TB and CD4<200 or in stage III/IV (Group 2)
      • notification
      • approval_date04-11-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-07-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-11-04 19:09:19
      • created2021-03-29 15:20:58
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id635
        • application_id993
        • given_nameHelena
        • middle_name
        • family_nameHuerga
        • qualificationMD, MSc, PhD
        • professional_addressEPICENTRE, CLINICAL RESEARCH DEPARTMENT, 14-34 AVENUE JEAN JAURES, 75019, PARIS
        • telephone+32 493 83 78 95
        • emailHelena.HUERGA@epicentre.msf.org
        • created2021-03-29 16:00:08
        • modified2021-07-12 07:44:39
    • SiteDetail(array)
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        • id879
        • application_id993
        • county_id(null)
        • site_name
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        • contact_details
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        • site_capacity(null)
        • misc(null)
        • created2021-03-29 16:00:08
        • modified2021-07-12 07:44:39
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id490
        • application_id993
        • sponsorMedecins Sans Frontieres /Epicentre
        • sponsor_typeResearch Institution
        • contact_personHelena Huerga
        • addressEPICENTRE, CLINICAL RESEARCH DEPARTMENT, 14-34 AVENUE JEAN JAURES, 75019, PARIS
        • telephone_number+32 493 83 78 95
        • fax_number
        • cell_number+32 493 83 78 95
        • email_addressHelena.HUERGA@epicentre.msf.org
        • created2021-03-29 16:00:08
        • modified2021-07-12 07:44:39
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    • Application(array)
      • id980
      • user_id622
      • trial_status_id6
      • abstract_of_study<p>\n <strong>TITLE: AN OPEN-LABEL, MULTICENTER STUDY TO ASSESS DISEASE ACTIVITY AND BIOMARKERS OF NEURONAL DAMAGE IN MINORITY PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH OCRELIZUMAB</strong></p>\n<p>\n <strong>PROTOCOL NUMBER: </strong>ML42071</p>\n<p>\n <strong>VERSION NUMBER: </strong>2</p>\n<p>\n <strong>EUDRACT NUMBER: </strong>2015-004616-37</p>\n<p>\n <strong>IND NUMBER: </strong>100,593</p>\n<p>\n <strong>NCT NUMBER: </strong><em>NCT04377555</em></p>\n<p>\n <strong>TEST PRODUCT: </strong>Ocrelizumab (RO4964913) (OCREVUS®)</p>\n<p>\n <strong>PHASE: </strong>IV</p>\n<p>\n <strong>INDICATION: </strong>Multiple Sclerosis</p>\n<p>\n <strong>SPONSOR: </strong>Genentech, Inc.</p>\n<p>\n <strong>Objectives and Endpoints</strong></p>\n<p>\n <strong>Primary Objective</strong></p>\n<ul>\n <li>\n The primary objective of this study is to assess disease activity during treatment with ocrelizumab over 48 weeks in <em>minorities represented by Black or African Americans with RMS </em>(AAwMS<em>) </em>and <em>Hispanic/Latinos with RMS (</em>HAwMS).</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives</strong></p>\n<ul>\n <li>\n The secondary objectives of this study are to evaluate other clinical measures of effectiveness, and biomarkers of disease activity and neuronal damage in serum, before and during treatment with ocrelizumab.</li>\n</ul>\n<p>\n <strong>Exploratory Objectives</strong></p>\n<ul>\n <li>\n The exploratory objectives of this study are to evaluate additional immune, ancestral, genomic, and other exploratory markers of disease and their correlations with disease severity and progression, including patient reported outcomes (PROs), before and during treatment with ocrelizumab.</li>\n</ul>\n<p>\n <strong>Safety Objectives</strong></p>\n<p>\n The safety objectives of this study are the following:</p>\n<ul>\n <li>\n Nature, frequency, severity, and timing of adverse events</li>\n <li>\n Adverse events related to biomarker sample collection (sub-study only)</li>\n <li>\n Vital signs, physical findings, and clinical laboratory results during and following ocrelizumab administration</li>\n</ul>\n<p>\n <strong>Study Design</strong></p>\n<p>\n <strong>Description of Study</strong></p>\n<p>\n This is an open-label, multicenter, Phase IV study that will be conducted at centers in the US including Puerto Rico <em>and Ex US sites (i.e., Kenya)</em>. Self-identified <em>Blacks or </em>AA and HA patients, aged 18−65 years of age, with a diagnosis of relapsing multiple sclerosis (RMS) in accordance with the 2017 revised McDonald criteria and an EDSS score of 0−5.5 points, at screening may be enrolled. Their treating neurologist must make an independent medical assessment and decision to initiate ocrelizumab treatment per label (USPI) as the most appropriate standard of care treatment for the patient.</p>\n<p>\n Patients will be evaluated at baseline, monitored, and followed for a 1-year period. Patients</p>\n<p>\n may continue in the study for a second year of treatment and follow-up (second year extension).</p>\n<p>\n Patients could be treatment naïve, or may be switching following treatment with up to two disease modifying therapies (DMT) (either interferon, glatiramer acetate, fingolimod, dimethyl fumarate (DMF), diroximel fumarate, teriflunomide, ozinamod, siponimod, and natalizumab).</p>\n<p>\n For patients switching over from fingolimod, DMF, diroximel fumarate, ozinamod, or siponimod, a minimum treatment-free period of 1 month is required before the baseline screening may be carried out. For patients switching from teriflunomide, an accelerated elimination procedure (per the product label) should be performed. Switch from natalizumab will require at least 4 months from last dose and a treatment duration of less than 1 year.</p>\n<p>\n Consistent with the USPI, ocrelizumab will be administered at a dose of 600 mg every</p>\n<p>\n 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given</p>\n<p>\n 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg</p>\n<p>\n IV infusion after 24 weeks. A minimum interval of 22 weeks must be maintained between each</p>\n<p>\n 600 mg dose of ocrelizumab.</p>\n<p>\n An alternative shorter infusion of subsequent 600 mg ocrelizumab doses in patients who did not</p>\n<p>\n experience a serious infusion-related reaction (IRR) with any previous ocrelizumab infusion is described</p>\n<p>\n in Section 4.3.2.1.</p>\n<p>\n Treatment may be stopped at any time due to lack of clinical benefit, unacceptable toxicity, withdrawal of consent, patient or physician decision to discontinue treatment, death, or if the sponsor decides to close the trial, whichever occurs first.</p>\n<p>\n Assessments will include clinical, PROs, MRI, and peripheral blood draws, as detailed in the</p>\n<p>\n SOA. MRIs will be conducted at baseline, at Week 24, and at Week 48. MRIs will be read by a central reader. In case of MS relapse or worsening, the patient should have an unscheduled visit and a full assessment, as detailed in the SOA.</p>\n<p>\n All patients may continue for a second year extension. During the optional second year extension, patients will receive: 2 additional doses of ocrelizumab (at Weeks 48 and 72); clinical, PRO, and peripheral blood evaluations at Weeks 72 and 96; and one MRI at Week 96.</p>\n<p>\n All patients will be evaluated for safety throughout the study. In the case of early termination, the patient will be asked to return for an early termination visit.</p>\n<p>\n Patients who do not meet the criteria for participation in this study (screen failure) may qualify for two additional re-screening opportunities (for a total of three screenings per participant) at the investigator's discretion.</p>\n<p>\n <strong>Number of Patients</strong></p>\n<p>\n Approximately 150 patients will be enrolled including 75 self-identified AAwMS and 75 selfidentified HAwMS.</p>\n<p>\n  </p>\n<p>\n <strong>Target Population</strong></p>\n<p>\n Inclusion Criteria</p>\n<p>\n Patients must meet the following criteria for study entry:</p>\n<ul>\n <li>\n Ability to provide written informed consent and be compliant with the study protocol</li>\n <li>\n The treating neurologist’s independent medical assessment and decision to initiate the patient on ocrelizumab treatment as most appropriate standard of care for the patient</li>\n <li>\n Age 18-65 years inclusive at the time of signing Informed Consent Form</li>\n <li>\n Diagnosis of RMS in accordance with the revised 2017 McDonald Criteria (Thompson et al 2018) EDSS 0-5.5 inclusive at enrollment.</li>\n <li>\n Patients who self-identify as Black or African American or Hispanic/Latino American.</li>\n <li>\n Treatment-naïve patients, or initiating first or second switch from receiving treatment with any of the following classes of disease-modifying therapies (including FDA approved generic versions):</li>\n</ul>\n<p style=\"margin-left:.25in;\">\n <em>Class 1</em></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Interferons: (IFN)-β-1a (Avonex, Rebif), IFN-β-1b(Betaseron/Betaferon), Peg-Interferon Beta-1a (Plegridy) or</li>\n <li>\n Glatiramer acetate (Copaxone), including generic glatiramer acetate</li>\n</ul>\n<p style=\"margin-left:.25in;\">\n <em>Class 2</em></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia)</li>\n <li>\n Dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity)</li>\n <li>\n Teriflunomide (Aubagio)</li>\n</ul>\n<p style=\"margin-left:.25in;\">\n <em>Class 3</em></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n Natalizumab (Tysabri)</li>\n</ul>\n<p>\n For patients switching over from any of the Class 2 agents, at least 1-month of treatment free period between the last dose of the DMT and the initiation of screening Additionally, for patients switching from teriflunomide (Aubagio), an accelerated elimination procedure is required during the treatment free period (as per teriflunomide USPI, see below).</p>\n<p>\n â–ª After discontinuation of teriflunomide, elimination can be accelerated by either one of the following procedures:</p>\n<p>\n Administration of cholestyramine 8 g every 8 hours for 11 days. If</p>\n<p>\n cholestyramine 8 g three times a day is not well tolerated,</p>\n<p>\n cholestyramine 4 g three times a day can be used</p>\n<p>\n Administration of 50 g oral activated charcoal powder every 12 hours for 11 days.</p>\n<p>\n If either elimination procedure is poorly tolerated, treatment days do not need to be consecutive unless there is a need to lower teriflunomide plasma concentration rapidly</p>\n<p>\n Note: Use of the accelerated elimination procedure may potentially</p>\n<p>\n result in return of disease activity if the patient had been</p>\n<p>\n responding to teriflunomide treatment</p>\n<p>\n ï‚· For patients switching over from Natalizumab, at least 4 months from last infusion and less than</p>\n<p>\n <em>1 year of total treatment duration</em></p>\n<p>\n · Disease duration from the onset of MS symptoms: any duration of the disease except for</p>\n<p>\n those patients with EDSS >5 where disease duration should be <15 years.</p>\n<p>\n · At least one documented clinical attack (for naïve patients) or suboptimal response, or poor</p>\n<p>\n adherence, or intolerance to prior DMT (for switch patients) in the past year, 2 documented clinical relapses within the last 2 years or 1 documented clinical relapse within 12 months of screening (but not within 30 days prior to screening) and/or at least one T1 Gd-enhancing lesion in the past year and/or at least one new or expanding T2 lesion in the past year at the time of enrollment. For active SPMS, documented evidence of disability progression independent of clinical relapse over the past 12 months from screening and at least one documented clinical relapse within the previous 2 years before screening or at least 1 T1 Gd enhancing lesion on MRI at screening if no clinical relapses within the previous 2 years.</p>\n<p>\n · For women of childbearing potential: agreement to remain abstinent (refrain from</p>\n<p>\n heterosexual intercourse) or use acceptable contraceptive methods during the treatment</p>\n<p>\n period and for 6 months after the final dose of ocrelizumab.</p>\n<p>\n A woman is considered to be of childbearing potential if she is postmenarchal, has not</p>\n<p>\n reached a postmenopausal state (12 continuous months of amenorrhea with no</p>\n<p>\n identified cause other than menopause), and has not undergone surgical sterilization</p>\n<p>\n (removal of ovaries and/or uterus). The definition of childbearing potential may be</p>\n<p>\n adapted for alignment with local guidelines or requirements.</p>\n<p>\n <strong>– </strong>The following are acceptable contraceptive methods (as defined by the guidelines):</p>\n<p>\n progesterone-only hormonal contraception, where inhibition of ovulation is not the</p>\n<p>\n primary mode of action; male or female condom with or without spermicide; and cap,</p>\n<p>\n diaphragm, or sponge with spermicide. More effective contraceptive methods</p>\n<p>\n (e.g., bilateral tubal ligation; male sterilization; copper intrauterine devices) may be</p>\n<p>\n used, but are not required.</p>\n<p>\n · <em>Neurologically stable for at least 30 days prior to randomization and baseline assessments</em></p>\n<p>\n Exclusion Criteria</p>\n<p>\n Patients who meet any of the following criteria will be excluded from study entry:</p>\n<p>\n · MS Related</p>\n<p>\n <strong>– </strong>Diagnosis of secondary progressive MS without relapses for at least 1 year (<em>nonactive or inactive SPMS)</em></p>\n<p>\n <strong>– </strong>PPMS</p>\n<p>\n · Patients with contraindication to gadolinium based contrast agent for MRI <em>and patients who cannot tolerate MRI procedure</em></p>\n<p>\n · Infection Related</p>\n<p>\n <strong>– </strong>Known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis,</p>\n<p>\n <em>HPV</em>)</p>\n<p>\n <strong>– </strong>History of recurrent aspiration pneumonia requiring antibiotic therapy</p>\n<p>\n <strong>– </strong>History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy)</p>\n<p>\n <strong>– </strong>Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with</p>\n<p>\n IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit</p>\n<p>\n · Cancer Related</p>\n<p>\n <strong>– </strong>History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix or the uterus that have been excised and resolved with documented clean margins on pathology)</p>\n<p>\n · Pregnant or lactating, or intending to become pregnant during the study</p>\n<p>\n <strong>– </strong>Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.</p>\n<p>\n · Other Medical Conditions</p>\n<p>\n <strong>– </strong>History of or currently active primary or secondary immunodeficiency</p>\n<p>\n <strong>– </strong>History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies</p>\n<p>\n <strong>– </strong>History of alcohol or other drug abuse within 24 weeks prior to enrollment</p>\n<p>\n <strong>– </strong>History or known presence of systemic autoimmune disorders, potentially causing progressive neurologic disease (e.g., <em>rheumatoid arthritis</em>, lupus, anti-phospholipid antibody syndrome, Sjögren’s syndrome, Behçet’s disease)</p>\n<p>\n <strong>– </strong>Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study</p>\n<p>\n <strong>– </strong>Significant, uncontrolled disease, as defined by AMA guidelines or similar, such as cardiovascular (including congestive heart failure – NYHA grade 3 or 4, cardiac arrhythmia), uncontrolled hypertension, pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), gastrointestinal, or any other significant disease</p>\n<p>\n · Known presence or history of other neurologic disorders, including but not limited to, the</p>\n<p>\n following:</p>\n<p>\n <strong>– </strong>Progressive multifocal leukoencephalopathy, CNS or spinal cord tumor, potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)</p>\n<p>\n <strong>– </strong>History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis; mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes</p>\n<p>\n [MELAS])</p>\n<p>\n <strong>– </strong>Neuromyelitis optica spectrum disorders (NMOSD)</p>\n<p>\n <strong>– </strong>Ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia</p>\n<p>\n of the spinal cord</p>\n<p>\n <strong>– </strong>Severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal</p>\n<p>\n cord compression)</p>\n<p>\n <strong>– </strong>Psychosis not yet controlled by a treatment</p>\n<p>\n · Drug Related</p>\n<p>\n <strong>– </strong>Systemic corticosteroid therapy within 4 weeks prior to baseline</p>\n<p>\n <strong>– </strong>Contraindications for, or intolerance to, oral or IV corticosteroids, including IV</p>\n<p>\n methylprednisolone, according to the country label, including hypersensitivity to any of</p>\n<p>\n the treatment drug constituents</p>\n<p>\n <strong>– </strong>Previous treatment with any other immunomodulatory or immunosuppressive medication not</p>\n<p>\n already listed above without appropriate washout as described in the applicable local label</p>\n<p>\n <strong>– </strong>If the washout requirements are not described in the applicable local label, then the washout</p>\n<p>\n period must be 5 times the half-life of the medication. The pharmacodynamic effects of the</p>\n<p>\n previous medication must also be considered when determining the required time for washout.</p>\n<p>\n · Prior DMT for MS</p>\n<p>\n <strong>– </strong>Previous treatment with natalizumab for more than 1-year and within 4 months of baseline</p>\n<p>\n visit.</p>\n<p>\n <strong>– </strong>Previous treatment with alemtuzumab or cladribine</p>\n<p>\n <strong>– </strong>Previous treatment with any anti-CD20 therapy</p>\n<p>\n <strong>– </strong>Previous treatment with cyclophosphamide, mitoxantrone, azathioprine, mycophenolate</p>\n<p>\n mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow</p>\n<p>\n transplantation</p>\n<p>\n <strong>– </strong>Previous or concurrent treatment with any investigational agent or treatment with any</p>\n<p>\n experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous</p>\n<p>\n insufficiency)</p>\n<p>\n · Vaccinations:</p>\n<p>\n <strong>– </strong>Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within</p>\n<p>\n 6 weeks prior to first administration of ocrelizumab</p>\n<p>\n · Laboratory: Certain laboratory abnormalities or findings at screening, including the</p>\n<p>\n following:</p>\n<p>\n <strong>– </strong>Positive serum β-hCG</p>\n<p>\n <strong>– </strong>Positive for hepatitis B (hepatitis B surface antigen [HBsAg] positive or hepatitis B core</p>\n<p>\n antibody [total HBcAb] confirmed by positive viral DNA polymerase chain reaction</p>\n<p>\n [PCR])</p>\n<p>\n <strong>– </strong>Positive screening test for hepatitis C (positive hepatitis C antibodies)</p>\n<p>\n <strong>– </strong>AST or ALT ³2.0 ´upper limit of normal</p>\n<p>\n <strong>– </strong>Platelet count below lower limit of normal (LLN)</p>\n<p>\n <strong>– </strong>Absolute neutrophil count below LLN</p>\n<p>\n <strong>– </strong>Lymphocyte count below LLN</p>\n<p>\n <strong>– </strong>Serum IgG and/or IgM levels below LLN</p>\n<p>\n <strong>– </strong>Absolute CD4+ and CD8+ T Cell counts below LLN</p>\n<p>\n · Any previous use of IV immunoglobulins or plasmapheresis 3 months prior to baseline visit.</p>\n<p>\n  </p>\n<p>\n <strong>End of Study</strong></p>\n<p>\n The end of this study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis whichever occurs later. The end of the study is expected to occur 12 months after the last patient is enrolled for the main study.</p>\n<p>\n Note: Patients may opt into one additional year of treatment and evaluation as part of the second year extension.</p>\n<p>\n In addition, the Sponsor may decide to terminate the study at any time.</p>\n<p>\n  </p>\n<p>\n <strong>Length of Study</strong></p>\n<p>\n The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 5 years.</p>\n<p>\n  </p>\n<p>\n <strong>Investigational Medicinal Products</strong></p>\n<p>\n <strong>Test Product (Investigational Drug)</strong></p>\n<p>\n The investigational medicinal product (IMP) for this study is ocrelizumab.</p>\n<p>\n The ocrelizumab dose administered will be 600 mg every 24 weeks. The first dose of</p>\n<p>\n ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart (Weeks 0 and</p>\n<p>\n 2). For the subsequent doses, ocrelizumab will be administered as a single 600-mg IV infusion every 24 weeks (Weeks 24, 48, and 72). A minimum interval of 22 weeks must be maintained</p>\n<p>\n between each dose of ocrelizumab. This dosing regimen is consistent with the dosing regimen</p>\n<p>\n used in the ocrelizumab USPI.</p>\n<p>\n  </p>\n<p>\n <strong>Non-Investigational Medicinal Products</strong></p>\n<p>\n In this study, non-investigational medicinal products will include premedication to the</p>\n<p>\n ocrelizumab infusion. The following premedication will be used:</p>\n<p>\n · Mandatory methylprednisolone (or an equivalent)</p>\n<p>\n · Mandatory antihistaminic drug (e.g., diphenhydramine)</p>\n<p>\n · Recommended oral analgesic/antipyretic (e.g., acetaminophen 1 g)</p>\n<p>\n  </p>\n<p>\n <strong>Statistical Methods</strong></p>\n<p>\n <strong>Primary Analysis</strong></p>\n<p>\n In this study, the analyses will be mostly descriptive and hypothesis-generating. Unless otherwise specified, statistical tests will be two sided and the statistical significance level will be</p>\n<p>\n 5%. Corresponding 95% confidence intervals will be presented as appropriate. No corrections</p>\n<p>\n for multiple testing will be applied to the primary, secondary, exploratory endpoint analyses.</p>\n<p>\n The statistical summaries will be descriptive if not otherwise specified. For continuous variables, the mean, median, standard deviation, 25th and 75th percentiles, minimum and maximum will be provided. For categorical variables, number and percentage in each category will be displayed. Full details of all statistical issues and planned statistical analyses will be specified in a separate Statistical Analysis Plan (SAP), which will be finalized prior to the locking of the study database.</p>\n<p>\n The spearman’s rank-correlation coefficient will be used to evaluate the relationship among the levels of biomarkers or between levels of biomarkers and clinical outcomes.</p>\n<p>\n <strong>Determination of Sample Size</strong></p>\n<p>\n Based on CHORDS study, MN30035, it is estimated that the proportion of AAwMS patients who will be free of protocol defined events during 48 weeks is 38%. Assuming the same expected proportion for HAwMS patients, this study is planned to enroll total 150 patients (75 in each patient cohort). This sample size can provide 95% confidence intervals of proportion of patient who will be free of protocol defined events in each patient cohort to be (27.0%, 49.9%) using the exact Clopper-Pearson method.</p>\n<p>\n <strong>Interim Analyses</strong></p>\n<p>\n Approximately three interim analyses may be performed during the course of the study,</p>\n<p>\n according to patient enrollment and availability of data of interest. Interim analyses may be</p>\n<p>\n used for internal decision making, hypothesis generation, abstract/publication for major MS</p>\n<p>\n conferences, or other purposes, as applicable. Details on the timing and scope of interim analyses will be described in the SAP.</p>\n<p>\n For the CSF sub-study, interim analyses may be performed when:</p>\n<p>\n · After approximately 50% patients in both the AAwMS and HAwMS cohort have undergone baseline CSF assessments</p>\n<p>\n · After approximately 100% patients in both the AAwMS and HAwMS cohort have undergone baseline CSF assessments</p>\n<p>\n · After approximately 50% of patients in each cohort (AAwMS and HAwMS) complete Week 48</p>\n<p>\n  </p>\n
      • study_title<div>\n AN OPEN-LABEL, MULTICENTER STUDY TO ASSESS DISEASE ACTIVITY AND BIOMARKERS OF NEURONAL DAMAGE IN MINORITY PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH OCRELIZUMAB</div>\n
      • laymans_summary<ul>\n <li>\n This research study is testing a drug called ocrelizumab in patients that have relapsing multiple sclerosis (RMS). </li>\n <li>\n Ocrelizumab is a type of drug called a monoclonal antibody.  Ocrelizumab has been shown to slow disability progression in multiple sclerosis (MS).  Monoclonal antibodies act like the body’s immune system and attach to certain cells that attack germs and other illnesses in the body.  Ocrelizumab attaches to certain types of white blood cells (B cells) that are thought to play a role in MS.</li>\n <li>\n The purpose of this study is to investigate the impact of ocrelizumab on RMS in Blacks or African Americans with multiple sclerosis (AAwMS) and Hispanic/Latino Americans with multiple sclerosis (HAwMS).  This study will also investigate the impact of ocrelizumab on certain biomarkers of RMS in Blacks or African American (AA) and Hispanic/Latino American (HA) minority patients with RMS.  A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.</li>\n <li>\n Ocrelizumab is already approved for the treatment of MS in several countries including, the United States of America, Australia, Canada, the European Union, and others.  It was approved by the FDA March 28, 2017.  The purpose of this study is to specifically study the efficacy and safety of the ocrelizumab in Blacks or AA and HA patients with RMS, and to gain in-depth understanding of the underlying disease process.</li>\n <li>\n The purpose of this study is to find out what effects, good or bad, ocrelizumab has on RMS.  This study will also look at the way ocrelizumab may change certain biomarkers related to RMS in the body.</li>\n <li>\n A CSF sub-study will be optional and conducted at selected sites. 50 patients (~25 Blacks/AAwMS and ~25 HAwMS) will be optionally enrolled in the CSF sub-study. There will be a separate consent form for the CSF sub-study</li>\n <li>\n About 150 people aged 18-65 years with a diagnosis of RMS will take part in this study, including 75 self-identified Blacks or AAwMS and 75 self-identified HAwMS.</li>\n <li>\n This non-randomized open label study</li>\n <li>\n The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 5 years.</li>\n</ul>\n<p>\n  </p>\n
      • short_titleCHIMES
      • protocol_noECCT/21/03/07
      • version_no2
      • date_of_protocol16-12-2020
      • study_drugOcrelizumab
      • disease_conditionMultiple Sclerosis
      • 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_nameOcrevus
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresshuwaida.bulhan@roche.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_letter0
      • 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_applicantGilbert Ogetii
      • declaration_date130-03-2021
      • declaration_principal_investigatorProf Mansoor Saleh
      • declaration_date230-03-2021
      • placebo_presentNo
      • study_objectives<p>\n <u>Primary Objective</u></p>\n<p>\n The primary objective of this study is to assess disease activity during treatment with ocrelizumab over 48 weeks in minorities represented by Black or African Americans with RMS (AAwMS) and Hispanic/Latinos with RMS (HAwMS).</p>\n<p>\n <u>Secondary Objectives</u></p>\n<p>\n The secondary objectives of this study are to evaluate other clinical measures of effectiveness, and biomarkers of disease activity and neuronal damage in serum, before and during treatment with ocrelizumab</p>\n<p>\n <u>Exploratory Objectives</u></p>\n<p>\n The exploratory objectives of this study are to evaluate additional immune, ancestral, genomic, and other exploratory markers of disease and their correlations with disease severity and progression, including patient reported outcomes (PROs), before and during treatment with ocrelizumab.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p 1ex=\"\" color:=\"\" font-size:=\"\" helvetica=\"\" line-height:=\"\" margin:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; font-family: \">\n Inclusion Criteria:</p>\n<ul font-size:=\"\" helvetica=\"\" margin-bottom:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; margin-top: 1ex; margin-left: 0px; padding-left: 24px; color: rgb(0, 0, 0); font-family: \">\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Participants who self-identify as Black or African American or Hispanic/Latino American</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Neurologically stable for at least 30 days prior to randomization and baseline assessments</li>\n</ul>\n
      • principal_exclusion_criteria<p 0ex=\"\" 0px=\"\" color:=\"\" font-size:=\"\" helvetica=\"\" line-height:=\"\" margin:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; font-family: \">\n Exclusion Criteria:</p>\n<ul font-size:=\"\" helvetica=\"\" margin-bottom:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; margin-top: 1ex; margin-left: 0px; padding-left: 24px; color: rgb(0, 0, 0); font-family: \">\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Primary Progressive Multiple Sclerosis (PPMS)</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Infection Related</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Cancer Related</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Pregnant or lactating, or intending to become pregnant during the study</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Other Medical Conditions</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Known presence or history of other neurologic disorders</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab</li>\n <li style=\"box-sizing: border-box; line-height: 1.6; margin-bottom: 4px; margin-top: 0.7ex;\">\n Laboratory: abnormalities or findings at screening</li>\n</ul>\n
      • primary_end_points<p>\n <strong>Primary Efficacy Endpoint: </strong>The primary efficacy endpoint will be the proportion of patients who are free of any protocol-defined events during a 48-week study.</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyBiomarkers
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<p>\n The site is fully staffed with specifically research-trained as well as clinical care staff. </p>\n<p>\n The site is able to cater to both emergency, critical care as well as intensive care in terms of facilities and trained staff. The site had a feasibility visit performed by the Sponsor in January 2020 and was qualified as a site that could successfully undertake an interventional clinical trial in Kenya. The site successfully completed an Industry sponsored COVID-19 clinical trial and was inspected by the Pharmacy and Poisons Board in Dec2020 – no major or critical finding.</p>\n<p>\n The PI will have two sub-Investigators assisting her. In addition, there are the following research-trained staff members on hand: </p>\n<ol>\n <li>\n Principle Investigator - Prof. Mansoor Saleh, MD – Professor of Medicine & Pathology Unit</li>\n <li>\n Co-Invetigatigator – Dr Dilraj Sokhi, MD - Neurologist</li>\n <li>\n Co-investigator – Dr Juzar Hooker, MD - Neurologist   </li>\n <li>\n Study Coordinator - Joyce Marete, RN & Aisleen Shamshudin (pharmacist)</li>\n <li>\n Regulatory Coordinator - Stacey Gondi </li>\n <li>\n Research Pharmacist & Drug Shipment - Aisleen Shamshudin (registered pharmacist)</li>\n <li>\n Pharmacy Technician & Drug Shipment - Nancy Owiti </li>\n <li>\n Data Manager - Grace Kirathe </li>\n <li>\n Research Program Manager - Noureen Karimi </li>\n <li>\n Research Patient Navigator - Innocent Abayo </li>\n <li>\n Contracts Coordinator - Innocent Abayo </li>\n <li>\n Payments and Budget - Noureen Karimi </li>\n</ol>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n US Food and Drug Administration - Approval date 21-Mar-2020</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable - None</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 years
      • 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_stateYes
      • location_of_areaAga Khan University, Nairobi
      • single_site_physical_address3rd Parklands Avenue, Nairobi-Kenya
      • single_site_contact_personProf Mansoor Saleh
      • single_site_telephone+254 709 93 1500
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listUnited States of America (USA) and Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_site10
      • total_participants_worldwide150
      • 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNot Applicable
      • investigator1_middle_name
      • investigator1_family_nameNot Applicable
      • investigator1_qualificationNot Applicable
      • investigator1_professional_addressNot Applicable
      • investigator1_telephoneNot Applicable
      • investigator1_emailmansoor.saleh@aku.edu
      • organisations_transferred_Yes
      • number_participants10
      • notification<p>\n This a first of a kind clinical trial in Africa (and Kenya in particular) as blacks and ethnic minorities are underreprented in multiple sclerosis clincial trials (<span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">Together </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">minorities </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">represent approximately one-third of </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">the multiple sclerosis (MS) </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">population </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">but </span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">their representation in major clinical trials for MS in less than 5%</span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">-</span><span style=\"font-variant-numeric: normal; font-variant-east-asian: normal;\">10% of all patients</span>). Therefore, this trial will not only give an opportunity for Kenya MS patients to participate in a therapeutic clinical trial but also open the window for the conduct of other therapeutic clinical trials in neuroscience, in Kenya.</span></span></p>\n<p>\n  </p>\n
      • approval_date08-06-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-03-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-11-06 19:34:18
      • created2021-02-26 14:32:15
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id627
        • application_id980
        • given_nameMansoor
        • middle_name
        • family_nameSaleh
        • qualificationMD, Professor of Medicine & Pathology
        • professional_addressAga Khan University, AKU Cancer Center 3rd Parklands Avenue, Nairobi-Kenya
        • telephone+254 709 93 1500
        • emailmansoor.saleh@aku.edu
        • created2021-03-02 16:38:33
        • modified2021-03-30 19:48:06
    • SiteDetail(array)
      • 0(array)
        • id860
        • application_id980
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-03-02 16:38:33
        • modified2021-03-30 19:48:06
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id483
        • application_id980
        • sponsorGenentech, Inc/Roche Kanya Ltd
        • sponsor_typeIndustry
        • contact_personGilbert Ogetii
        • addressRoche Kenya Limited The Atrium, 6th Floor Chaka Road, off Lenana Road P.O. Box 44212-00100 Nairobi, Kenya
        • telephone_number +254 780 441 913
        • fax_number
        • cell_number +254 780 441 913
        • email_addressGilbert.Ogetii@roche.com
        • created2021-03-02 16:38:33
        • modified2021-03-30 19:48:06
  • 2(array)
    • Application(array)
      • id960
      • user_id613
      • trial_status_id7
      • abstract_of_study<p>\n Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) are important health problems worldwide with TB remaining one of the greatest threats to public health and a leading cause of death from an infectious pathogen. It is also known that the HIV epidemic has fueled the resurgence of TB leading to dramatic increase in TB infections in low and middle income countries. The development of appropriate antiretroviral (ARV) and TB drug regimens in pregnant and postpartum women is critical to providing optimal care to women living with human immunodeficiency virus (HIV) and/or TB, and their infants to prevent disease progression There are limited studies looking at pharmacokinetics of ARVs and TB drugs during pregnancy and post-partum.</p>\n<p>\n The study will enroll women who are already on select ARVs and TB medications under study with the aim of obtaining pharmacokinetic(PK) parameters of these medications when used alone or in combination during pregnancy and post-partum in women living with and without HIV by drawing PK samples at various time points. Breastmilk will also be collected from some participants during the postpartum period. The study is comprised of 5 components based on the ARVs or TB medications the participants are receiving. Kericho site will enroll into components 3 and 5. Component 3 are pregnant women living with HIV receiving ARVs and first line TB treatment and their infants while component 5 are postpartum women living with HIV breastfeeding while receiving ARVs and their infants.</p>\n<p>\n Data obtained from this study will establish the effect of pregnancy on drug exposure and also the kinetics of transmission ARVs and TB treatment drugs from mother to infant and thus inform guidelines on appropriate ARVs and TB medications during pregnancy and lactation.</p>\n<p>\n Kericho site will enroll up to 30 mother infant pairs intothe study, 10 mother infant pairs will be enrolled into component 5 while 20 mother infant pairs will be enrolled into component 3. Participants who will be enrolled into component 3 will be enrolled in the second or third trimester and be in the study up to 24 weeks after delivery. Those in component 5 will be enrolled immediately after delivery and followed up for 24 weeks.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum</strong></p>\n
      • laymans_summary<p>\n <strong>Title</strong>: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum.</p>\n<p>\n <strong>Lay Title</strong>: Effect of HIV and TB medicines when taken during pregnancy and after delivery.</p>\n<p>\n <strong>What is theproblem/background?</strong></p>\n<p>\n Clinical trials studying the breakdown, absorption and excretion of antiretroviral (ARV) and tuberculosis (TB)medication during pregnancy and/or postpartum, are limited.Obtaining data on how pregnancy affects drug exposure isimportant so that safe and effective doses of ARVs and anti- tuberculin medications for pregnant women can be prescribed.</p>\n<p>\n <strong>What questionsarewetryingtoanswer?</strong></p>\n<p>\n The study seeks to establish the amounts of certain ARVs and TB medications in women taking this medications during pregnancy and postpartum period and also at how much of these medications are transferred from mother to infants during breastfeeding. The aim is to obtain data on how pregnancy affects breakdown and absorption of these medications thus ensure safe and effective use of these medicines during pregnancy and breastfeeding.</p>\n<p>\n <strong>Where is the study taking place,how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will take place in multiple sites, Kericho being one of them. The study will enroll a total of 325 participants across all sites into 5 components. A total of 30 participants (mother-infant pairs) will be enrolled in Kericho, 20 into component 3 and 10 into component 5. The participants will be selected by active identification and referral from surrounding health facilities.</p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n Participants will be enrolled while on selected ARVs and anti-TB medications. They will continue taking these medications while on study. Blood samples will be taken during pregnancy and after they deliver. Blood samples will also be taken from infants of mothers enrolled during pregnancy.</p>\n<p>\n <strong>Whatarethebenefitsandrisks/costsofthestudyforthoseinvolved?</strong></p>\n<p>\n The mothers and infants in the study will benefit from provision of ancillary medical care from entry to completion of the study at no cost to the them. The risks of this study are mainly due to blood collection which may cause pain, bruising, swelling, or fainting. There is a very small chance of infection where the needle is inserted. It may be uncomfortable to express breast milk. Blood collection from infants will be done by heel stick, which may cause some discomfort, bleeding or bruising at the site of the heel stick. There is also risk of breach of confidentiality.</p>\n<p>\n <strong>H</strong><strong>ow will the study benefit society?</strong></p>\n<p>\n Information learned from this study may be of benefit to participants and others in the future.</p>\n<p>\n  </p>\n<p>\n <strong>When does the study start and finish?</strong></p>\n<p>\n The study is expected start in the first quarter of 2021 and take approximately 5 years to end in the year 2026.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleP2026
      • protocol_noECCT/21/03/06
      • version_noversion 1.0
      • date_of_protocol22-01-2020
      • study_drugBictegravir (BIC), Doravirine (DOR), Tenofovir Alafenamide (TAF), Cabotegravir (CAB)
      • disease_conditionTB and HIV in pregnancy
      • 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_nameBictegravir (BIC), Doravirine (DOR), Tenofovir Alafenamide (TAF), Cabotegravir (CAB)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.org
      • 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_applicantDr. Lucy C. Koech ,MBChB.
      • declaration_date102-12-2020
      • declaration_principal_investigatorDr. Lucy C. Koech ,MBChB.
      • declaration_date202-12-2020
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objectives</h2>\n<h2>\n <span style=\"font-size: 12px;\"> 1.   Component 3: Describe the PK parameters during pregnancy and postpartum of selected ARV drugs and first-line TB treatment drugs co-administered to WLHIV.</span></h2>\n<ol>\n <li value=\"2\">\n Component 5: Describe the kinetics of drug transfer of selected ARVs from mother to infant via breast milk.</li>\n</ol>\n<h2>\n <strong>Secondary Objectives</strong></h2>\n<ol>\n <li>\n All Components: Describe maternal and infant safety and clinical outcomes.</li>\n <li>\n Components 1, 3 and 4: Compare drug concentrations in plasma from cord blood with concentrations in maternal plasma at delivery for selected ARV and/or TB treatment drugs.</li>\n <li>\n Components 1, 3 and 4: Describe the neonatal elimination of selected ARV and/or TB treatment drugs acquired across the placenta after maternal dosing during pregnancy.</li>\n <li>\n Components 3 and 4: To describe the kinetics of drug transfer of selected ARVs and/or TB treatment drugs from mother to infant via breast milk.</li>\n</ol>\n<h2>\n <strong>Other Objectives</strong></h2>\n<ol>\n <li>\n Assess plasma protein binding of highly bound ARVs and/or TB treatment drugs during pregnancy and postpartum.</li>\n <li>\n Explore genetic sources for variability in drug exposure in pregnant women, postpartum women, and infants for selected ARV and/or TB treatment drugs.</li>\n</ol>\n<p class=\"MsoListParagraphCxSpLast\" style=\"text-indent:-.25in;mso-list:l1 level1 lfo3\">\n <!--[if !supportLists]--><span new=\"\" style=\"font-size:12.0pt;line-height:107%;font-family:\" times=\"\">4.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">   </span></span>Kericho site will participate in components 3 and 5.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Component 3 Inclusion Criteria</strong></p>\n<ol>\n <li>\n Mother is aged16 years or above and is willing and able to provide written informed consent for her own and her infant’s participation in this study. As per KEMRI IRB SOPs,mature minors aged 16 years and above can consent for themselves and their infants. The legal age for independent consent in Kenya is 18 years.</li>\n <li>\n Prior to study entry, HIV status confirmed as HIV infected. HIV confirmation will be done at the Kericho site Laboratory which operates under good clinical laboratory practice (GCLP).</li>\n <li>\n At study entry, pregnant and in one of the following two enrollment windows, based on best available obstetrical estimate of gestational age:</li>\n</ol>\n<ul>\n <li>\n Second trimester: gestational age of 20 0/7 to 26 6/7 weeks</li>\n <li>\n Third trimester: gestational age of 30 0/7 to 37 6/7 weeks</li>\n</ul>\n<ol>\n <li value=\"4\">\n At study entry, receiving at least two of the following first-line TB treatment drugs under study AND at least one of the following ARV drugs or drug combinations under study, based on maternal report and available medical records:</li>\n</ol>\n<p>\n              First-line TB treatment drugs:</p>\n<ul>\n <li>\n Isoniazid (INH) 4-6 mg/kg (max 300 mg) q.d.</li>\n <li>\n Rifampicin (RIF) 8-12 mg/kg (max 600 mg) q.d</li>\n <li>\n Rifabutin (RFB) 150-300 mg q.d.</li>\n <li>\n Ethambutol (EMB) 15-20 mg/kg q.d.</li>\n <li>\n Pyrazinamide (PZA) 20-30 mg/kg q.d.</li>\n <li>\n Moxifloxacin (MFX) 400 mg or 800mg q.d.</li>\n <li>\n  </li>\n <li>\n ARVs</li>\n <li>\n Arm 3.1 Dolutegravir (DTG) 50 mg b.i.d. when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen</li>\n <li>\n Arm 3.2 Atazanavir/ritonavir (ATV/r) t of the TB q.d. or Darunavir/ritonavir (DRV/r) t of the TB rb.i.d.</li>\n <li>\n Arm 3.3 Lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d.</li>\n</ul>\n<ol>\n <li>\n At study entry, has been receiving the drug combination under study at the required dose for at least two weeks based on maternal report and available medical records.</li>\n <li>\n At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 – 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.</li>\n <li>\n At study entry, if receiving a generic ARV or TB formulation of the drug or drug combination under study, approval of the formulation per section 5.1 on page 54 of the Sponsor protocol.</li>\n <li>\n At study entry, planning to continue the current ARV regimen through at least 8 weeks post-delivery, based on maternal report and available medical records.</li>\n</ol>\n<p>\n <strong>Component 5 Inclusion Criteria</strong></p>\n<ol>\n <li>\n .Mother is aged 16 years or above and is willing and able to provide written informed consent for her own and her infant’s participation in this study. As per KEMRI IRB SOPs, mature minors aged 16 years and above can consent for themselves and their infants. The legal age for independent consent in Kenya is 18 years.</li>\n</ol>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n Prior to study entry, HIV status confirmed as HIV infected</li>\n <li value=\"3\">\n At study entry, within 5-9 days post-delivery (inclusive).</li>\n <li value=\"4\">\n At study entry, breastfeeding mother-infant pair intends to continue exclusive breastfeeding through at least 16 weeks post-delivery.</li>\n <li value=\"5\">\n At study entry, mother is receiving any of the following oral ARV drugs or drug combinations:</li>\n</ol>\n<ul>\n <li>\n <strong>Arm 5.1 </strong>Atazanavir/ritonavir (ATV/r)</li>\n <li>\n <strong>Arm 5.2 </strong>Darunavir/ritonavir (DRV/r)</li>\n <li>\n <strong>Arm 5.3 </strong>Lopinavir/ritonavir (LPV/r)</li>\n</ul>\n<ol>\n <li value=\"6\">\n At study entry, mother has been receiving the drug(s) or drug combination(s) under study at the required dose for at least two weeks, based on maternal report and available medical records.</li>\n <li value=\"7\">\n At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within the 5-9 days post-delivery PK sampling window.</li>\n <li value=\"8\">\n At study entry, mother is planning to continue the current ARV regimen through at least 16 weeks post-delivery, based on maternal report and available medical records.</li>\n <li value=\"9\">\n At study entry, if receiving a generic ARV formulation of the drug or drug combination under study, approval of the formulation.</li>\n <li value=\"10\">\n At study entry, infant weighs at least 1000 grams, based on available medical records.</li>\n <li>\n At study entry, infant does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator.</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Component 3 Exclusion criteria</strong></p>\n<ol>\n <li>\n At study entry, mother has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records.</li>\n</ol>\n<ol>\n <li value=\"2\">\n At study entry, has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the ARV or TB drug under study during the period of study follow-up.</li>\n</ol>\n<p>\n Note: Participants will not be co-enrolled with other studies without approval from the protocol team.</p>\n<p>\n <strong>Exclusion Criteria for Component 5</strong></p>\n<ol>\n <li>\n Mother is currently enrolled in Component 3.</li>\n <li>\n At study entry, the mother or infant has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records</li>\n <li>\n At study entry, mother or infant has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the drug under study during study follow-up.</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Component 3: Describe the PK parameters during pregnancy and postpartum of selected ARV drugs and first-line TB treatment drugs co-administered to WLHIV.</li>\n</ol>\n<p style=\"margin-left:31.5pt;\">\n  </p>\n<ol>\n <li value=\"2\">\n Component 5: Describe the kinetics of drug transfer of selected ARVs from mother to infant via breast milk.</li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Kericho CRC has a total of 152 staff with the necessary professional backgrounds and experience to support the clinical trials. The staff consist of 6 doctors (one obstetrician/gynecologist, two infectious disease doctors, one public health physician, a consultant pediatrician, and a medical officer), 15 clinical officers, two pharmacists, one pharmaceutical technologist, 24 nurses, 45 laboratory technologists, 3 IT specialists, 12 data entry staff among others.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The site has five full time doctors that will participate in study implementation and participants’ care, one of whom is a Critical Care Pediatrician (Dr Tsikhutsu), and will be available to oversee newborns who may require care during delivery neonetal period and throughout the study.The study staff (clinicians/nurses) are trained on handling emergencies. Participants will be managed at USAMRD-A/K CRC for outpatient services and when participants require inpatient services, they will be admitted at Unilever Tea Kenya (UTK) Central Hospital which is a private company facility owned by the UTK tea company</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\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 KEMRI SERU approval dated Nov 05 2020</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • 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_stateYes
      • location_of_areaKENYA MEDICAL RESEARCH INSTITUTE/WALTER REED PROJECT CLINICAL RESEARCH CENTER
      • single_site_physical_addressOFF HOSPITAL ROAD
      • single_site_contact_personLUCY CHEPKURUI KOECH
      • single_site_telephone+254522036100
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sites
      • multi_country_listBotswana Uganda India\nTanzania Thailand Brazil\nUSA South Africa Malawi\nZimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide325
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameWinnie
      • investigator1_middle_nameChelangat
      • investigator1_family_nameKeter
      • investigator1_qualificationDip. Clinical medicine
      • investigator1_professional_addressP.O Box 1357 – 20200,Hospital Road, Kericho, Kenya.
      • investigator1_telephoneTel: +254 052 20 36100 Mobile: +254 717 844997
      • investigator1_emailWinnie.keter@usamru-k.org
      • organisations_transferred_No
      • number_participants60
      • notification
      • approval_date07-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-03-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-06-17 14:11:53
      • created2020-12-02 09:24:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id607
        • application_id960
        • given_nameDr. Lucy
        • middle_nameChepkurui
        • family_nameKoech
        • qualificationMBChB
        • professional_addressP.O Box 1357 – 20200,Hospital Road, Kericho, Kenya.
        • telephoneTel: +254 052 20 36100 Mobile: +254 719193275
        • emailLucy.koech@usamru-k.org
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
    • SiteDetail(array)
      • 0(array)
        • id840
        • application_id960
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id470
        • application_id960
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_person
        • address5601 Fishers Lane
        • telephone_number1-240-292-4788
        • fax_number
        • cell_number1-240-292-4788
        • email_addressbetsysmith@niaid.nih.gov
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
  • 3(array)
    • Application(array)
      • id981
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n Snakebite affects over 5 million people each year, and over 100,000 per year die as a result. Children and young people bear the greatest burden, and the majority of bites occur in remote rural settings with limited access to medical services. The only available treatment is antivenom, an animal product produced through a process of exposing large mammals to repeated sublethal doses of snake venom. Antivenom has many shortcomings, including high cost, intravenous administration, high risk of adverse events and narrow species specificity. The venom of vipers predominantly consists of Snake Venom Metalloproteinases (SVMPs), which are zinc dependent enzymes. SVMPs cause blood vessel breakdown, consumption coagulopathy and skin necrosis. Pre-clinical research, including use of the same in vivo experiments that are the gold standard for assessing antivenom, have shown that metal chelators can potently inhibit the activity of viper venom, by deactivating SVMPs. Through systematic screening of a range of chelating agents, unithiol has been identified as the most promising chelating agent and needs further evaluation in clinical trials. As well as preventing skin damage and death in vivo, unithiol is a safe and well tolerated drug that has been is use as a treatment for heavy metal poisoning for many decades. We propose a phase I clinical trial to assess unithiol as a treatment for snakebite.</p>\n<p>\n The primary outcome will be to determine safety and tolerability of a dosing regimen that is relevant to snakebite. The pharmacokinetic and pharmacodynamic profile of unithiol will also be described. Healthy Kenyan volunteers will be invited to enroll from Kilili County. Volunteers will be randomized into dosing cohorts of 8. The first dosing cohort will receive 300 mg of oral unithiol, which is the dose normally used for heavy metal poisoning. With review of safety, single ascending dose escalations will be made with the aim of giving a maximum dose of 1,500 mg oral. A minimum of two further cohorts will receive intravenous doses of unithiol, as this route may be useful for rapidly achieving therapeutic levels. Following review of the emerging data, two cohorts will receive multiple doses of unithiol for up to 72 hours, which will be the anticipated regimen for snakebite treatment.Pharmacokinetic analysis will be undertaken to calculate the half-life, Cmax and to define the elimination of unithiol in the urine. Pharmacodynamic analysis will include application of a novel ex vivo assay for quantifying the inhibition of SVMP associated pathology.</p>\n
      • study_title<p>\n TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)</p>\n
      • laymans_summary<p>\n <strong>What is the problem/background?</strong></p>\n<p>\n Every year 94,000 people die following a snakebite.  In Kilifi County Hospital alone, there have been 1,500 snakebites requiring hospital admission since 2007. The only treatment available (antivenom – a product made by repeatedly exposing mammals, such as horses, to sub-lethal doses of venom) is expensive and can cause allergic reactions. Many snake venoms require zinc to function. Drugs that stick to and remove zinc (‘chelators’, including unithiol) have been shown to deactivate these snake venoms in laboratory experiments.</p>\n<p>\n Unithiol is a treatment for heavy metal poisoning (such as arsenic or mercury poisoning) and has been in use as an established therapy for a number of decades. It is known to bind to zinc. This drug is available as an oral capsule as well as a solution for intravenous injection into the blood-stream. As far as we are aware, unithiol is not routinely available in Kenya, and it is not registered with the pharmacy and poisons board (PPB). For many years, safety data has been collected for unithiol elsewhere and overall it is a safe drug with minimal risk of serious side effects. When unithiol is used as a treatment for snakebite, laboratory experiments suggest that higher doses may be needed, compared to doses normally used for treating heavy metal poisoning.</p>\n<p>\n Unlike antivenom, unithiol is available as a capsule and could be stocked in rural clinics, which would reduce delays to accessing snakebite treatment. Unithiol has been used for the treatment of metal poisoning for many years and there is a reasonable amount of reassuring safety data.</p>\n<p>\n In this study, groups of healthy Kenyan people were given increasing amounts of unithiol and closely monitored to check if this is safe.</p>\n<p>\n <strong>What questions did we answer?</strong></p>\n<p>\n 1) Can higher oral doses of unithiol be safely given to healthy adult Kenyan voluneteers?</p>\n<p>\n 2) What are the drug levels of unithiol and how long are drug levels maintained after each dose?</p>\n<p>\n 3) Can a new method of measuring the activity of unithiol in blood samples, to inhibit the actions of venom, produce reliable results?</p>\n<p>\n <strong>What did this study tell us?</strong></p>\n<p>\n 1) Increased oral doses of unithiol were well tolerated and safe in this small group of healthy adult Kenyan volunteers.</p>\n<p>\n 2) Drug levels in the blood stream were were proportionally higher as the oral dose of unithiol was increased. At a higher dose (above 1,200 mg), the rate of gut absorption seemed to prevent blood levels from increasing any further, therefore, doses above this level are not recommended.</p>\n<p>\n 3) It was not possible to develop a reliable new method of measuring the activity of unithiol in blood to inhibit the actions of venom. Future studies to assess whether unithiol provides benefit in individuals with snakebite are a priority.</p>\n<p>\n <strong>What will happen next?</strong></p>\n<p>\n Future studies are being planned to test the increased oral dose developed in this study in people with snakebite. If unithiol were to demonstrate clinical benefit (such as reducing the risk of abnormal bleeding in snakebite patients) then it may be developed as a treatment that can routinely be given in community settings. This could reduce the time to treatment, reduce our reliance on antivenom, and ultimately reduce the burden of death and disability caused by snakebite.</p>\n
      • short_titleUnithiol Phase I
      • protocol_noECCT/21/03/05
      • version_no2
      • date_of_protocol05-11-2020
      • study_drugUnithiol
      • disease_conditionHealthy volunteers
      • 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_nameUnithiol
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • 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_addendum0
      • 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_applicantDr Mainga Hamaluba
      • declaration_date125-03-2021
      • declaration_principal_investigatorDr Michael Abouyannis
      • declaration_date225-03-2021
      • placebo_presentNo
      • study_objectives<p>\n Primary objective: to determine safety and tolerability of unithiol in healthy Kenyan adults.</p>\n<p>\n Secondary objective: to define the pharmacokinetic profile of unithiol in healthy Kenyan adults.</p>\n<p>\n Exploratory objective: To explore <em>ex vivo </em>efficacy of unithiol at varying doses to inhibit the pathogenic activity of <em>Echis ocellatus </em>and other venoms that rely on snake venom metalloproteinases</p>\n
      • principal_inclusion_criteria<p>\n • Capable of giving informed consent</p>\n<p>\n • Male or female</p>\n<p>\n • KHDSS resident</p>\n<p>\n • 18-64 years old (inclusive)</p>\n<p>\n • Body weight 50-120kg</p>\n<p>\n • In good health, as determined by the investigator following medical history, drug history, examination, vital signs, ECG and blood tests</p>\n<p>\n • Willing to be admitted to the in-patient facility for up to 5 days for dosing and intensive blood sampling</p>\n<p>\n • On effective contraception as defined by: Use of effective method of contraception for duration of study (women only). We will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).</p>\n
      • principal_exclusion_criteria<p>\n • Prescribed a concomitant medication other than paracetamol or an appropriate contraceptive, which in the opinion of the Investigator warrants exclusion.</p>\n<p>\n • Any significant current or past history of cardiovascular, respiratory, renal or hepatic disease.</p>\n<p>\n • Subjects who have taken any non-prescribed herbal medication or mineral supplement in the preceding 7 days, which in the opinion of the Investigator warrants exclusion.</p>\n<p>\n • Subject with clinically significant abnormal vital signs at screening</p>\n<p>\n • Abnormal laboratory findings deemed significant by the Investigator</p>\n<p>\n • Subjects who are pregnant or lactating</p>\n<p>\n • Decline pre-trial screening, including HIV testing</p>\n<p>\n • HIV positive subjects will be excluded from the trial and, if not already receiving appropriate clinic follow-up, would be referred to a government clinic for ongoing care</p>\n<p>\n • Subjects with asthma (due to possible risk of exacerbation with allergic type skin reactions to unithiol)</p>\n<p>\n • Subjects that have donated blood within the past 3 months</p>\n<p>\n • Subjects who in the opinion of the investigator should not participate</p>\n
      • primary_end_points<p>\n Primary objective: to determine safety and tolerability of unithiol in healthy Kenyan adults.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyUnithiol is a repurposed drug that is routinely in use for treating heavy metal poisoning. We are conducting a safety trial as at higher doses there is pre-clinical evidence to suggest that unithiol may inhibit snakebite envenoming.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The site has long standing experience in conducting clinical research with currently over 200 studies in clinical research including phase I - IV trials. KEMRI-CGMRC has close to 1000 employees and about a third of them are scientists. All clinical trial staff are trained in acute resuscitation and in the event of emergencies provisions are in place for resuscitation and ambulance transfer to the Intensive Care Unit at the Aga Khan Hospital, Mombasa. If participants require non-critical care they will be admitted to the general wards where KEMRI staff will also oversee their care. The following staff will be supporting this trial:</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Clinical officer - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Nurses - 2</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Assistant Research Officer - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Data Manager - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n Data Clerk - 1</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \">\n All clinical staff are trained in basic life support and resuscitation facilities are available.</p>\n
      • other_details_explanation<p>\n The sponsor of the trial is the Liverpool School of Tropical Medicine. Since this therapeutic is being developed for use in a setting where snakebite is prevalent it is appropriate to conduct the trial in Kenya. Gains from this trial could lead top improvements in health outcomes in the study country.</p>\n
      • other_details_regulatory_notapproved<p>\n Nil. This trial is only being conducted in Kenya.</p>\n
      • other_details_regulatory_approved<p>\n Nil. This trial is only being conducted in Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n Nil.</p>\n
      • other_details_regulatory_halted<p>\n Not applicable.</p>\n
      • estimated_duration18 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_stateYes
      • location_of_areaKEMRI Wellcome Trust Research Programme
      • single_site_physical_addressHospital Grounds, Off Bofa Road, Kilifi, Kenya
      • single_site_contact_personMainga Hamaluba
      • single_site_telephone+254709983946
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteSingle site
      • total_participants_worldwide64
      • 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • 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_nameNA
      • investigator1_middle_name
      • investigator1_family_nameNA
      • investigator1_qualificationNA
      • investigator1_professional_addressNA
      • investigator1_telephoneNA
      • investigator1_emailmabouyannis@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants64
      • notification<p>\n Nil</p>\n
      • approval_date07-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-07-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved by the experts
      • final_report<h3>\n Background</h3>\n<p>\n Viperidae snakes are responsible for many of the 94,000 deaths caused by snakebite envenoming each year. The most pathological venom component of this globally diverse family of snakes are the zinc-dependent snake venom metalloproteinase (SVMP) enzymes, which can be inhibited by the metal chelator, unithiol. A short-course oral regimen, readily available and rapidly deployed ahead of hospital admission is needed.</p>\n<p>\n  </p>\n<h3>\n Methods</h3>\n<p>\n This open-label, phase 1 clinical trial assessed the safety of single ascending oral, multiple ascending oral, and single ascending intravenous doses of unithiol in 64 healthy adult volunteers from Kilifi County, Kenya. The multiple dose stage was informed by an interim safety and pharmacokinetic analysis, and predefined target plasma concentrations. Plasma concentrations of unithiol were measured using high-performance liquid chromatography-mass spectrometry, and safety was described by full adverse event reporting.</p>\n<h3>\n  </h3>\n<h3>\n Findings</h3>\n<p>\n 175 individuals were screened, and 64 (median age 30 years, IQR 25-38 years) received the study drug. There were no dose limiting toxicities or serious adverse events. There were 61 solicited adverse events, 17 related unsolicited adverse events, and 53 laboratory adverse events, all of mild or moderate severity. The maximum oral dose of 1,500 mg was well tolerated and associated with the following pharmacokinetic parameters: C_max 15.6 µg/mL, T_max 3.0 hours, T_1/2 18.4 hours, and AUC_0-last 180.9 h.µg/mL.</p>\n<p>\n  </p>\n<h3>\n Interpretation</h3>\n<p>\n The phase 2 recommended dose (1,500 mg loading dose, followed by 900 mg doses at 6-hours and 24-hours) is safe, and has promising pharmacokinetic properties for clinical use. Unithiol is affordable, stable at room temperature, and has the potential to be given orally in remote rural clinics. Its further development for snakebite indication is warranted.</p>\n<p>\n  </p>\n
      • implication_results<p>\n The results of this phase 1 trial will not have a direct bearing on clinical practice. The objective of this study was to develop an oral dosing regimen of unithiol for use in a future phase 2 efficacy trial assessing this treatment in people with snakebite. If future clinical trials demonstrate efficacy, then the dose developed in this phase 1 clinical trial may be used in routine practice.</p>\n<p>\n Unithiol has many potantial advantages over the current standard of care for treating snakebite with antivenom. Unithiol is more affordable to manufacture, has lower toxicity, can be adminsitered orally, and is likely to have broader effiacy against diverse snake species. However, efficacy needs to be confirmed in future clinical trials before unithiol could be recommended for routine use.</p>\n
      • quantity_importedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules -32; Dimaval®(DMPS) 100 mg Hard Capsule-405; Dimaval®(DMPS) 100 mg Hard Capsule-640.
      • quantity_dispensedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules-26; Dimaval®(DMPS) 100 mg Hard Capsule-312, Dimaval®(DMPS) 100 mg Hard Capsule-624
      • quantity_destroyedDimaval 250 mg DMPS-Na/5 ml Solution for injection Ampoules-6; Dimaval®(DMPS) 100 mg Hard Capsule- 93; Dimaval®(DMPS) 100 mg Hard Capsule-16
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2025-09-17 13:22:07
      • created2021-03-01 13:52:34
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id624
        • application_id981
        • given_nameMichael
        • middle_name
        • family_nameAbouyannis
        • qualificationMBChB
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone+254727048061
        • emailmabouyannis@kemri-wellcome.org
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
      • 1(array)
        • id625
        • application_id981
        • given_nameMainga Patience Mayeso
        • middle_name
        • family_nameHamaluba
        • qualificationMBChB MRCPCH MD
        • professional_addressP.O.Box 230, Kilifi 80108, Kenya
        • telephone(+254) 795 3204 22
        • emailMHamaluba@kemri-wellcome.org
        • created2021-03-01 14:18:31
        • modified2021-07-09 11:35:36
    • SiteDetail(array)
      • 0(array)
        • id858
        • application_id981
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id481
        • application_id981
        • sponsorLiverpool School of Tropical Medicine
        • sponsor_typeResearch Institution
        • contact_person
        • addressPembroke St, Liverpool L3 5QA, UK
        • telephone_number+44(0)151 705 3100
        • fax_number
        • cell_number+44(0)151 705 3100
        • email_addresslindsay.troughton@lstmed.ac.uk
        • created2021-03-01 14:10:43
        • modified2021-07-09 11:35:36
  • 4(array)
    • Application(array)
      • id989
      • user_id667
      • trial_status_id8
      • abstract_of_study<p>\n Young women in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health.</p>\n
      • study_title<p>\n A Novel PrEP Delivery System to Meet the Needs of Young African Women</p>\n
      • laymans_summary<p>\n Young women (defined here as 16-24 years old) in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya where we will use a client-centered, iterative approach, involving individual interviews and focus group discussions to optimally design the PrEP My Way kit and peer delivery system. We will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. We will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.</p>\n
      • short_titlePrEP My Way
      • protocol_noECCT/21/03/03
      • version_noVersion 1.0
      • date_of_protocol29-10-2019
      • study_drugEmtricitabine/ Tenofovir Disoproxil Fumarate tablets
      • disease_conditionHIV
      • 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_nameTruvada
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.org
      • 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_addendum0
      • 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_applicantP.O Box 614, 40100
      • declaration_date117-03-2021
      • declaration_principal_investigatorNational Principal Investigator
      • declaration_date217-03-2021
      • placebo_presentNo
      • study_objectives<p>\n 1. Develop PrEP My Way. Using a client-centered approach, we will iteratively conduct individual interviews and focus group discussions with up to 25 Kenyan women (age 16-24) to optimally design PrEP My Way (the kit with instructional materials) and peer delivery system (including phone communication and kit delivery plans).</p>\n<p>\n 2. Assess PrEP My Way for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. We will randomize 100 Kenyan women (age 16-24) to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention). Potential influencing and mediating socio-behavioral factors will be explored with questionnaires at 0 and 6 months.</p>\n
      • principal_inclusion_criteria<p>\n o Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have not yet attained the age of legal competency as defined by state law, but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as self-support, marriage, or procreation) per Kenyan national guidelines [39]) or 16-17 year-olds with parental consent</p>\n<p>\n o Reported sexual activity within the past 3 months</p>\n<p>\n o Interest in taking PrEP (actual PrEP uptake is not a requirement for Aim 1)</p>\n<p>\n o Residence in the Kisumu region</p>\n<p>\n o Phone ownership o Ability to understand KiSwahili, DhoLuo, and/or English</p>\n
      • principal_exclusion_criteria<p>\n • Exclusion criteria- inability to provide informed consent (e.g., intoxication, mental disability)</p>\n
      • primary_end_points<p>\n Primary outcomes- Preliminary impact on PrEP adherence and program retention at 6 months. PrEP adherence will be assessed primarily by DBS for tenofovir diphosphate (TFV-DP) concentration. The TFV-DP concentration will provide an estimate of doses taken over the prior 3 months (see Table 4; [11, 50]). Retention will be assessed by kit receipt in the intervention arm and clinic attendance per clinic records in the control arm at Month 6. Potential influencing and mediating socio-behavioral factors (Table 2) will be explored</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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_other1
      • trial_other_specifyImplementation Science
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n PI- 1</p>\n<p>\n Co-ordinator- 1</p>\n<p>\n Research Assistants- 2</p>\n<p>\n Laboratory Technologist-1</p>\n<p>\n Pharmacist-1</p>\n<p>\n Pharmaceutical Technologist-1</p>\n<p>\n Data Lead-1</p>\n
      • other_details_explanation<p>\n The trial will be conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n Mass General BrigHam IRB</p>\n<p>\n Approved on December 01 2020</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration6 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_stateYes
      • location_of_areaKisumu
      • single_site_physical_addressOndiek Street
      • single_site_contact_personKevin Oware
      • single_site_telephone254 723873505
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site100
      • total_participants_worldwide100
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabet Ann
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, MMed, MPH, PhD
      • investigator1_professional_addressBox 19464, post code 00202, Nairobi
      • investigator1_telephone254 733617503
      • investigator1_emailebukusi@kemri.prg
      • organisations_transferred_No
      • number_participants100
      • notification<p>\n None</p>\n
      • approval_date06-07-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-05-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-07-10 10:19:36
      • created2021-03-17 14:40:13
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id632
        • application_id989
        • given_nameProf. Elizabet Ann
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, MMed, MPH, PhD
        • professional_addressBox 19464, post code 00202, Nairobi
        • telephone254 733617503
        • emailebukusi@kemri.prg
        • created2021-03-17 14:55:49
        • modified2021-05-25 09:21:39
    • SiteDetail(array)
      • 0(array)
        • id874
        • application_id989
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2021-03-17 14:55:49
        • modified2021-05-25 09:21:39
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id487
        • application_id989
        • sponsorMassachusetts General Hospital
        • sponsor_typeResearch Institution
        • contact_personJessica Haberer
        • address55 Fruit St, Boston, MA 02114, United States
        • telephone_number617-726-2000
        • fax_number
        • cell_number617-726-2000
        • email_addressJHABERER@PARTNERS.ORG
        • created2021-03-17 14:55:49
        • modified2021-05-25 09:21:39
• page_options(array)
  • 55
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• redir
• $request->data(array)
  • Application(empty)
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  • Permission(empty)
  • Aro(empty)
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  • Application(empty)
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  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
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  • 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

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    • 1CORE/Model/Behavior/ContainableBehavior.php
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      • 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