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      • abstract_of_study<p>\n <strong>Introduction </strong></p>\n<p>\n Sickle cell disease is one of the most commonly inherited blood disorders in the world characterized by vaso-occlusive crises, anemia, stroke and multiple organ damage. Vaso-occlusive crises are the most common presentation of sickle cell disease. Vaso-occlusive crises are caused by activation of the endothelial cells, neutrophils, monocytes and platelets by the sickled red blood cells. The activation of these cells leads to their expression of the p-selectin molecule promoting the aggregation and adhesion of these cells to one another and to the endothelial cells leading to clot formation and blockage of the microvascular channels.</p>\n<p>\n There is only one known cure of sickle cell disease, which is a hematopoietic stem cell transplant (HSCT). Unfortunately, this intervention is not easily accessible to most patients due to its cost and unavailability in the country. Most patients with sickle cell disease are therefore mainly on supportive treatment. These reasons inform the need for more affordable and accessible treatments.</p>\n<p>\n The study participants will have completed a study of inclacumab (originating study) and will receive inclacumab intravenous infusion in this open-label study. They will receive the intravenous treatment every 12 weeks. The mechanism of action of inclacumab is to prevent the action of p-selectin molecule, which reduces adhesion of molecules and leads to a reduction in the episodes of vaso-occlusive crises. The study aims to assess the safety of long-term administration of inclacumab in participants with SCD that have completed an inclacumab clinical trial. During the study period, participants can receive standard of care treatment except for crizanlizumab.</p>\n<div>\n  </div>\n<div>\n <strong>Methodology</strong></div>\n<div>\n  </div>\n<div>\n <strong>Study setting </strong></div>\n<div>\n The study will be carried out in up to 150 global clinical sites with a sample size of 520 participants. There will be approximately 5 sites in Kenya. We have three study sites in different parts of Nairobi, one in Siaya and the last one in Eldoret.</div>\n<div>\n  </div>\n<div>\n <strong>Study design </strong></div>\n<div>\n This study is an open-label extension study to evaluate the safety of long-term treatment with inclacumab in participants with SCD. The study will be available to eligible participants who were enrolled in a prior GBT-Sponsored inclacumab clinical study (originating study). Eligible participants, who continue to receive clinical benefit that outweighs risk, will receive inclacumab every 12 weeks until the participant has access to inclacumab from an alternative source. Given the long half-life of inclacumab (terminal half-life of 21 to 28 days) at the dose to be evaluated in this study, the majority of participants receiving active study drug are expected to maintain target concentrations as required throughout the study period.</div>\n<div>\n  </div>\n<div>\n <strong>INTRODUCTION & JUSTIFICATION</strong></div>\n<div>\n Sickle cell disease is one of the most commonly inherited blood disorders worldwide (Sj et al., 2017). It is estimated that approximately 300,000 children are born with sickle cell disease in the world annually, 75% of whom are from Sub-Saharan Africa (Makani et al., 2013). As there is no systematic neonatal screening program in most public and private facilities, there is no national prevalence data. However, it is estimated that 4% of children born in Western Kenya have sickle cell disease(Wanjiku et al., 2019). The study is being conducted in Kenya due to the high incidence of sickle cell disease in the country.</div>\n<div>\n  </div>\n<div>\n Sickle cell disease (SCD) is an autosomal recessive disease characterized by chronic haemolysis, inflammation and vaso-occlusion presenting as recurrent pain episodes (variously termed sickle cell-related pain crises or VOCs), multi-organ dysfunction, and early death (Kato, 2018).</div>\n<div>\n vaso-occlusion in SCD is driven by a series of complex and often redundant receptor–ligand interactions involved in the adhesion of circulating cells to the damaged endothelium and exposed sub-endothelium. Extensive research demonstrates that P-selectin mediated cellular interactions with sickled red blood cells (RBCs), leukocytes and platelets play a crucial role in the pathophysiology of vaso-occlusion in SCD. Blocking P-selectin-mediated cellular interactions reduces vaso-occlusion in animal models. Taken together, these data led to the hypothesis that blocking P-selectin could reduce the risk of VOCs in SCD patients.</div>\n<div>\n  </div>\n<div>\n Results from a randomized, placebo-controlled Phase 2b trial of crizanlizumab, a humanized monoclonal antibody in SCD, bolstered the hypothesis that blocking the interaction of P-selectin with its receptors could prevent vaso-occlusion and VOCs (Ataga, 2017). In summary, there is a high unmet need for treatment options in SCD and there is a scientific rationale, supported by clinical data, that p-selectin inhibition has the potential to reduce the risk for acute vaso-occlusions.</div>\n<div>\n  </div>\n<div>\n  </div>\n<div>\n <strong>JUSTIFICATION/RATIONALE</strong></div>\n<div>\n  </div>\n<div>\n Allogeneic HSCT remains the only curative therapy for sickle cell disease. It is however unavailable for most patients due to its high cost and it being available only in high income countries. It is also associated with various transplant complications (Kassim and Sharma 2017). Three therapies, hydroxyurea (HU [DROXIA®, 2017]; (also known as hydroxycarbamide), L-glutamine (ENDARI, 2017) and crizanlizumab (ADAKVEO®, 2019), have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to reduce VOCs in patients with SCD (Charache, 1995; Niihara, 2018; Ataga, 2017). The effectiveness of HU is impaired by low compliance rates and frequent discontinuations in treatment (Shah, 2019) while L-glutamine provides a modest 25% reduction in annual VOC rates (Niihara, 2018).</div>\n<div>\n  </div>\n<div>\n Crizanlizumab is a monoclonal antibody directed against human P-Selectin and is administered as an infusion every 4 weeks whereas inclacumab is to be administered every 12 weeks. The 4-week administration of crizanlizumab is a potential barrier to continued adherence to lifelong therapy because patients need to travel more frequently to an infusion centre to receive treatment. This regimen extracts a higher cost on patient and caregiver productivity and frequent intravenous infusions generally attract extra costs Version No: * Date of Protocol * Study Drug* Route(s) of Administration * Disease condition being investigated * Product Type * Name of manufacturer Manufacturing site address Phone Email Manufacturing activities at site If others, specify Country of manufacture to the patient. (Saini, 2009; Richter, 2003). It has also been shown that less frequent dosing results in better adherence to medication (Saini, 2009; Richter, 2003).</div>\n<div>\n  </div>\n<div>\n Inclacumab has a similar mechanism of action as crizanlizumab. Previous studies on inhibition of p-selectin through crizanlizumab, have demonstrated it to be efficacious and safe for use in SCD patients. Additionally, the dose selected is 30mg/kg every 12 weeks and from previous studies, population PK simulations project that the inclacumab dose regimen of 30 mg/kg Q12W will maintain concentrations above 10 μg/mL throughout the study period in the majority of participants, thereby maximizing the pharmacology required for effective reduction of VOC in the SCD population. The 12-week dosing for inclacumab offers a potential benefit over the 4-week dosing of crizanlizumab and this could increase patient adherence to treatment, reduce the costs of patient and caregiver productivity, leading to a reduction in the overall health costs. Treatments with stable standard of care are allowed except for crizanlizumab because it has a similar mechanism of action as the study drug and would confound the interpretation of this data.</div>\n<div>\n  </div>\n<div>\n In summary, despite the recent availability of new options to treat VOCs, an unmet medical need exists to further reduce the frequency of VOCs while reducing patient burden and enhancing patient adherence to therapy.</div>\n<div>\n  </div>\n<div>\n <strong>NULL HYPOTHESIS</strong></div>\n<div>\n  </div>\n<div>\n There is no null hypothesis.</div>\n<div>\n  </div>\n<div>\n <strong>OBJECTIVES</strong></div>\n<div>\n <strong>Primary objective</strong></div>\n<div>\n 1. To evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD that have completed a prior inclacumab clinical trial.</div>\n<div>\n  </div>\n<div>\n <strong>Additional objectives</strong></div>\n<div>\n  </div>\n<div>\n 2.To evaluate the incidence of VOCs, hospitalizations, missed work/school days, RBC transfusions, and quality of life (QoL) with long-term use of inclacumab.</div>\n<div>\n  </div>\n<div>\n <strong>STUDY DESIGN</strong></div>\n<div>\n  </div>\n<div>\n This study is a multicenter,global,open-label extention,designed to assess the safety of long-term treatment with inclacumab in participants with SCD.</div>\n<div>\n  </div>\n<div>\n Participants must have completed participation in their originating clinical study and must meet the entry criteria for this study to be eligible for enrolment. Eligible participants will receive Inclacumab 30 mg/kg administered IV Q12W; if they continue to receive clinical benefit that outweighs the risk, until the participant has access to inclacumab from an alternative source (e.g., through commercialization or a managed-access program).</div>\n<div>\n  </div>\n<div>\n All participants will undergo safety and outcome assessments at Baseline (Day 1), Week 6, and every 12 weeks thereafter. Visits to the clinical site for infusion of study drug will occur at Baseline (Day 1) and every 12 weeks (Weeks 12, 24, 36, 48, etc.).</div>\n<div>\n  </div>\n<div>\n Despite this being an open-label study, Investigators, study site staff, the Sponsor’s study staff, the Sponsor’s clinical CRO, and study participants will remain blinded to the randomized treatment assignments, as applicable, from the originating GBT-Sponsored inclacumab study. During the study, access to participants’ treatment assignment from the originating study will be limited to DMC members and service providers supporting DMC reviews, including the independent Data Coordinating Centre, until the database from the originating study is locked and primary endpoint analysis is complete. If a need arises for unblinding of the originating GBT-Sponsored inclacumab study, the instruction for unblinding as outlined in the originating study protocol will be followed.</div>\n<div>\n  </div>\n<div>\n A Data Monitoring Committee (DMC) will regularly review the totality of accumulated safety data from all ongoing inclacumab studies on an ongoing, unblinded basis with additional emphasis on adolescent participants. DMC review will continue until the originating studies have been completed and the randomization assignments are unblinded. Details will be provided in the DMC Charter.</div>\n
      • study_title<div>\n An Open-Label Extension Study to Evaluate the Long-Term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial</div>\n
      • laymans_summary<div>\n Sickle cell disease is an inherited blood disorder that causes frequent pain episodes, and multiple organ complications. Currently, there is only one known cure for sickle cell disease which is a bone marrow transplant that is inaccessible for most Kenyans. However, currently most patients are usually on treatments that help control the disease e.g. hydroxyurea and folic acid, or prevent infections e.g. palludrine and Penicillin V, or manage symptoms as they arise e.g. painkillers for pain episodes and blood transfusion for anemia. There is a need for new treatments that help improve the patients’ quality of life.</div>\n<div>\n Pain episodes are mainly caused by the blockage of blood flow to various parts of the body. One of the causes of this blockage includes formation of clots in the blood vessels. A molecule called p-selectin; produced by our bodies contributes to formation of this clots. GBT has developed a drug called inclacumab that prevents the function of p-selectin leading to a reduction in the formation of clots bringing about an overall decrease in pain episodes. The main aim of this study is to assess whether inclacumab is safe for use and if it reduces the number of vaso occlusive crises in patients with sickle cell disease when administered long-term.</div>\n<div>\n A total of 520 participants will be enrolled across 150 clinical sites globally. There will be about 5 sites in Kenya. 3 sites are in Nairobi 1 in Siaya and another one in Eldoret. The sites will enrol this participants following their participation in and receipt of inclacumab in another GBT-sponsored inclacumab clinical study.</div>\n<div>\n Participation in the study is voluntary and those enrolled have the possibility of benefiting from the study. If the drug proves to be efficacious there may be a reduction in the number of pain episodes. Additionally, participants will receive education on the disease. Participation in the study may also benefit health care workers and the local community who are actively involved with sickle cell disease management by providing more information on the treatment of the disease.</div>\n<div>\n There are potential risks associated with participation in the study and are mainly related to the side effects of the investigational product including but not limited to</div>\n<div>\n diarrhoea, vomiting, tiredness, nasal congestion, common cold symptoms and pain in the mouth and throat. Participants will be monitored for any side effects or sickness and if unwell treatment will be provided.</div>\n
      • short_titleGBT Open Label inclacumab Ph3
      • protocol_noECCT/22/04/01
      • version_noOriginal (V1.0)
      • date_of_protocol30-03-2021
      • study_drugInclacumab Nduba GBT2104_133
      • disease_conditionSickle Cell Disease
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
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      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameN/A
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
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      • declaration_applicantMillicent Aketch@gmail.com
      • declaration_date107-04-2022
      • declaration_principal_investigatorDr. Videlis Nduba
      • declaration_date207-04-2022
      • placebo_presentNo
      • study_objectives<div>\n <strong>Main Objective</strong></div>\n<div>\n The primary objective of this study is to:</div>\n<div>\n  </div>\n<div>\n <strong>1.</strong> evaluate the long-term safety of every 12 week dosing of inclacumab in participants with sickle cell disease (SCD) that have completed a prior inclacumab clinical trial.</div>\n<div>\n  </div>\n<div>\n <strong>The secondary Objective</strong></div>\n<div>\n Additional objectives are to:</div>\n<div>\n  </div>\n<div>\n <strong>1</strong>.Evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC)</div>\n<div>\n transfusions, and quality of life (QoL) with long-term use of inclacumab</div>\n
      • principal_inclusion_criteria<div>\n 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.</div>\n<div>\n 2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.</div>\n<div>\n 3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.</div>\n<div>\n Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study.</div>\n<div>\n 4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.</div>\n<div>\n 5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement</div>\n
      • principal_exclusion_criteria<div>\n 1. Female participant who is breastfeeding or pregnant.</div>\n<div>\n 2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study.</div>\n<div>\n 3. Participant withdrew consent from the originating inclacumab clinical study.</div>\n<div>\n 4. Participant was lost to follow-up from the originating inclacumab clinical study.</div>\n<div>\n 5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may</div>\n<div>\n confound safety interpretation, interfere with compliance, or preclude informed consent.</div>\n
      • primary_end_points<p>\n Not applicable</p>\n
      • scope_diagnosis0
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      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
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      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
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      • design_controlledNo
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      • staff_numbers<p>\n <strong>Kisumu/Siaya</strong></p>\n<p>\n Site Site activities are located in Kisumu/Siaya and Nairobi Counties. Kisumu hosts the main IP storage site, administrative offices of the PI and co-investigators, procurement and Human Resource functions are housed at the KEMRI Kisian Campus. Recruitment, follow-up of study participants will occur in Siaya.</p>\n<p>\n KEMRI has a modern research annex at the Siaya county hospital with capacity to conduct phase I to Phase III studies. After community mobilization, screening and enrollment, IP dispensation will occur at the Siaya Clinical Research Annexe.</p>\n<p>\n Site investigators responsible for day to day running of the project include: Medical Officer 2, Pharmacist 1, Pharm tech 2, Nurses 5, Quality Assurance Officer 2, Quality Control 1, Clinical Officer 2, Community Interviewers 4.</p>\n<p>\n <strong>KEMRI/CRDR clinical research Site</strong></p>\n<p>\n Site activities will take place within the KEMRI/CRDR clinical research annex. This facility has several clinical rooms available for consenting, nursing procedures, clinical exams and dosing. There are also additional facilities that include an inpatient ward, staff work areas and a monitoring space, a pharmacy, laboratory and kitchen for preparing participant meals.</p>\n<p>\n Site staff include the principal investigator, 4 medical officers, 2 pharmacists, 1 pharmtech, 5 nurses, 5 quality assurance officers, 3 clinical officers and 6 community health workers.</p>\n<div>\n <strong>International Cancer Institute-Eldoret</strong></div>\n<div>\n The Investigator (PI) has adequate staff and have the necessary time,capacity and availability to conduct the study, including site management, collection, processing and shipment of lab samples. Below is the list of the staff at the site:</div>\n<div>\n - Dr Fredrick Chite -PI - Joyce Chizi Kiti- Medical officer - Mercy Cherop-Biostatistician - Hildah Kaziga Chavera- Medical Officer -</div>\n<div>\n Collins Saina- Pharmacist - David Wambasi-Nurse - Stephen Karuru-Data manager - George Gitau Thumbi-Laboratory Technologist</div>\n<div>\n  </div>\n<div>\n <div>\n The site is in a spacious compound and has 5 building. The main clinic buildings, the Pharmacy, laboratory, an office for the study Coordinator and additional personnel (essential documents are stored in a locked cabinet in this office). The main administrative building has individual work space, the Investigators office, a reception area, ablution blocks and individual works space cabins. The site has an access-controlled pharmacy, with shelving for storage of IP and non-IP products. There are consultation rooms, a nursing station with emergency equipment which also serves as a reception area and a procedure room.</div>\n <div>\n  </div>\n <div>\n The clinic is fully equipped to handle emergencies and the site has a 5-bed additional bed capacity that can be used as a temporary inpatient facility. The clinic also has a counselling room which will be used for the consenting process. Each consultation room is equipped with a desk, computer which is video enabled, a lamp, an examination couch, a trolley, a wooden lockable cabinet for supplies, equipment required to perform examinations e.g. sphygmomanometer, stethoscopes and several other scopes, blood collection tools e.g tourniquets. The site will outsource Xray services and laboratory services</div>\n <div>\n that require an accredited laboratory to Lancet laboratories. The site has a high-speed internet.</div>\n <div>\n  </div>\n <div>\n <strong>Strathmore University Medical Centre (SUMC) Site</strong></div>\n <div>\n  </div>\n <div>\n The SUMC is designed for clinical trials and has a full clinical laboratory with bioanalytical capability. The Centre is managed by Strathmore University and the CREATES consortium. The Centre also has a dental unit.</div>\n <div>\n  </div>\n <div>\n The medical centre is staffed by 2 pediatricians, 2 physicians, 1 medical officer, 1 clinical officer, 4 dental surgeons, 3 psychologists, 1 pharmacist, 1 visiting psychiatrist, 1 physician assistant, 4 nurses and 4 laboratory technologists. The facility supports healthcare to university students and staff and also general public. The centre currently runs a SCD clinic every Tuesday.</div>\n <div>\n  </div>\n <div>\n Location The Sickle Cell study will be conducted at SUMC; recruitment will occur at the clinic. SUMC is located at Strathmore University in Madaraka Estate of Nairobi west, Nairobi County. SUMC will be staffed by qualified research personnel from KEMRI and SUMC. The site has a pharmacy, treatment area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done. SUMC currently runs a SCD clinic with more than 200 patients on follow up comprising of both adults and children.</div>\n <div>\n  </div>\n <div>\n Provision of medical care SUMC is an outpatient facility with a 2-bed holding unit and a separate emergency resuscitation area. The centre serves as a clinical trials facility for both paediatric and adult studies. The participants who will require inpatient care will be admitted to Coptic Hospital Ngong Road as SUMC already has an existing working arrangement. As for the Sickle cell disease, there is a database in place that has over 200 patients and we hope to base our recruitment on this list.</div>\n <div>\n The SUMC is also linked to other private, government, non-governmental and county health facilities, in Nairobi County that take care of patients with SCD. For the care of sickle cell patients, the SCD clinic will work closely with the study team.</div>\n <div>\n  </div>\n <div>\n <strong>Gertrude’s Children’s Hospital Site:</strong></div>\n <div>\n  </div>\n <div>\n Gertrude’s Children’s Hospital (GCH) is one of the largest hospital in East and Central Africa dedicated exclusively to the care of children. For over 60 years, the hospital has provided high standards of paediatric care for children from birth to 21 years of age. The hospital is accredited by the Joint Commission International Accreditation and Safe Care, Netherlands following audits of the hospital facilities.</div>\n <div>\n  </div>\n <div>\n GCH is a non-profit organization, chartered with the responsibility of provision of health services, fostering good health, carrying out research and teaching healthcare professionals. Based in Muthaiga, Nairobi, and spread out to various outpatient clinics all over Nairobi and in several other Counties, the hospital attends to over 300,000 children as outpatients and admits over 6,000 patients on average per year.</div>\n <div>\n  </div>\n <div>\n The over 100-bed hospital offers comprehensive paediatric medical services and there are 21 specialist clinics that cover almost every aspect of paediatric healthcare from haematology, chest conditions, cardiology, dermatology, otorhinolaryngology, endocrinology, oncology and HIV/AIDS. Primary care services are also offered including a Well Baby and Immunization clinic.</div>\n <div>\n  </div>\n <div>\n The laboratory is equipped with modern equipment and offers diagnostic laboratory testing in all areas of pathology and is headed by a pathologist supported by several other pathologists, laboratory manager and qualified medical laboratory technologists. The hospital laboratory and pharmacy cater for both children and adults. The laboratory is accredited by Kenya Accreditation Service as a medical testing laboratory (ISO15189:2012). Qualified pharmacists manage the hospital pharmacy. GCH has an up-to-date paediatric imaging facility that is managed by a team of radiologists and qualified radiographers. Most of the processes at the hospital are fully computerized and supported by a well-integrate Information Technology Department. The main hospital in Muthaiga is open 24/7 and offers 24-hour laboratory and pharmacy coverage. The Accident and Emergency Department is well equipped to deal with all forms of paediatric emergencies and has a crash cart and crash team on call, 24 hours a day. There are registered nurses, medical officers and specialists specifically trained in Emergency Triage Assessment and Treatment. The Team is fully trained to handle emergencies, including but not limited to airway obstruction and other breathing problems; circulatory impairment or shock; severely altered central nervous system function (coma or convulsive seizures); and severe dehydration which require urgent appropriate care to prevent death. The Hospital runs an Institute of Child Health and Research based at the Muthaiga site which is approved by the Nursing Council of Kenya.</div>\n <div>\n The school offers courses in paediatric endocrinology, paediatric phlebotomy, emergency paediatric medicine and several specialised paediatric nursing courses. The Hospital has an Ethics Review Committee (ERC) that acts independently from the appointing authority, hosting institution, researchers, sponsors and any other stakeholders in its review and decision-making processes. The ERC is accredited by the National Commission for Science and Technology and Innovation (NACOSTI), an institution mandated to advise the Government on policies and matters relating to the scientific and technological activities and research required for the proper development of the country. The population served by the hospital is cosmopolitan and English and Kiswahili are the predominantly spoken languages.</div>\n <div>\n  </div>\n <div>\n <strong>Site Study Staff Details.</strong></div>\n <div>\n  </div>\n <div>\n <div>\n The site has a multidisciplinary study team that comprises specialists and professionals in many fields of medicine including; medical officers, paediatricians, haematologists, oncologists, pathologists, nurses, pharmacists, medical laboratory technologists. The Team has members who have been trained on the job as study coordinators. The team members are experienced in clinical trials and have all been trained in Good Clinical Practice and most have successfully participated in several other clinical trials.</div>\n <div>\n  </div>\n <div>\n <strong>Site personnel roles and responsibilities</strong></div>\n <div>\n  </div>\n <div>\n <strong>Principal Investigator</strong> • Prof Jessie Githanga A qualified haematologist/clinical pathologist, registered by the Kenya Medical</div>\n <div>\n Practitioners and Dentists Council (KMPDC). She will be responsible for the overall conduct of the trial at the study site,</div>\n <div>\n budgetary negotiations, administrative actions and communication between Institutional Review Boards, and the sponsor and</div>\n <div>\n oversight of patient care. She will oversee the recruitment of the subjects and directly supervise study staff.</div>\n <div>\n  </div>\n <div>\n <strong>Co-Investigator/main coordinator</strong> • Dr. Doreen Karimi Mutua A qualified paediatrician, with subspecialty training in</div>\n <div>\n paediatric haemato-oncology working at GCH and registered by the KMPDC. Dr Mutua will be responsible for clinical care</div>\n <div>\n provision of the patients, assist in supervision of study staff and will also participate in study recruitment. Dr Mutua supports</div>\n <div>\n PI and has roles that may be delegated such as ethical and sponsor communication and may be delegated related roles.</div>\n <div>\n  </div>\n <div>\n <strong>Study Coordinator </strong>: • Dr Joy Githua A qualified medical officer, registered by the KMPDC working at GCH. She will be the</div>\n <div>\n main coordinator for the study and will be responsible for day to day management of trial aspects including participant</div>\n <div>\n recruitment, follows up, safety monitoring, data entry and maintaining the site files and other study records and may be</div>\n <div>\n delegated related roles.</div>\n <div>\n  </div>\n <div>\n <strong>Study Pharmacist and assistant: </strong>Dr Samuel Madere (pharmacist) • Crecencia Nekesa Makokha (pharmaceutical technologist) Qualified pharmacist, registered</div>\n <div>\n by the Pharmacy and Poison’s Board (PPB), will be delegated roles of the IP storage and related duties, dilution of IP and dispensing, processing of import permit for IP and may be delegated related roles. He will be assisted by a pharmaceutical technologist.</div>\n <div>\n  </div>\n <div>\n <strong>Study nurses:</strong> • Hannah Wanjiku (assistant study coordinator) • Felicity Kamundi • Jane Nduati A registered nurse, registered</div>\n <div>\n by the Nursing Council of Kenya, will be responsible for co-ordinating the patient visits, taking patent vital signs and patient</div>\n <div>\n training. The assistant study coordinator will in addition be the assistant study coordinator.</div>\n <div>\n  </div>\n <div>\n <strong>Laboratory Manager</strong>: Peninah Chege: Laboratory manager registered by the Kenya Medical Laboratory Technologists and</div>\n <div>\n Technicians Board (KMLTTB) will coordinate laboratory functions, process the import permits for laboratory items, equipment</div>\n <div>\n and may be delegated related roles. Laboratory technologist/phlebotomist • Charles Muia (technologist) • Herman</div>\n <div>\n Akumu(technologist) • Joseph Langat (phlebotomist) Trained laboratory technologists registered by the KMLTTB and trained in</div>\n <div>\n Good Clinical Practice (GCP) and phlebotomist who will obtain specimens from study participants. The technologists will</div>\n <div>\n perform any local laboratory testing where necessary and package specimens for shipping to Central or other local labs.</div>\n <div>\n  </div>\n <div>\n <strong>Quality Assurance Officer •</strong> Winnie Abuto Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and</div>\n <div>\n GCP trained. She will be tasked with ensuring that study documents are quality controlled so that they are Attributable,</div>\n <div>\n Legible, Contemporaneous, Original, and Accurate (ALCOA) in accordance GCP guidelines. She will ensure that staff are</div>\n <div>\n alerted to changes in standard operating procedures (SOPs) as necessary.</div>\n <div>\n  </div>\n <div>\n <strong>Administrative assistant </strong>• Truphena Otinyo The Administrative assistant will coordinate and maintain the records of</div>\n <div>\n communications with the ERC, assist the main coordinator in patient visit coordination. She may be delegated related roles.</div>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A, trial is being conducted in USA</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n <div>\n <strong>Country </strong></div>\n </td>\n <td>\n <strong>date</strong></td>\n <td>\n <strong>submited status</strong></td>\n </tr>\n <tr>\n <td>\n France</td>\n <td>\n 20 Sep2021</td>\n <td>\n pending</td>\n </tr>\n <tr>\n <td>\n Kenya</td>\n <td>\n 23 Fen 2022</td>\n <td>\n pending</td>\n </tr>\n <tr>\n <td>\n Nigeria</td>\n <td>\n 25 May 2021 </td>\n <td>\n pending</td>\n </tr>\n <tr>\n <td>\n Ghana </td>\n <td>\n 27 Aug 2021 </td>\n <td>\n pending</td>\n </tr>\n <tr>\n <td>\n N/A</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n N/A</td>\n <td>\n  </td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n <strong>country approved </strong></td>\n <td>\n <strong>date aproved </strong></td>\n <td>\n <strong>number of sites</strong></td>\n </tr>\n <tr>\n <td>\n <div>\n Germany</div>\n </td>\n <td>\n 10 Nov 2021</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n <div>\n Italy </div>\n </td>\n <td>\n 04 Aug 2021</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n <div>\n Brazil </div>\n </td>\n <td>\n 29 Jun2021</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n <div>\n Colombia</div>\n </td>\n <td>\n  29 Nov 2021</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n <div>\n Egypt </div>\n </td>\n <td>\n 01 Sep 2021</td>\n <td>\n 8</td>\n </tr>\n <tr>\n <td>\n <div>\n saudi Arabia </div>\n </td>\n <td>\n 08 Dec 2021</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n <div>\n Turkey </div>\n </td>\n <td>\n 26 Dec 2021</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n <div>\n United Kingdom </div>\n </td>\n <td>\n 27 Oct 2021</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n <div>\n unites states of America </div>\n </td>\n <td>\n 11 Dec 2020</td>\n <td>\n 25</td>\n </tr>\n <tr>\n <td>\n Zambia </td>\n <td>\n 11 Jan 2022</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Kenya </td>\n <td>\n 22 Mar 2022</td>\n <td>\n 1  out of 5 site approved </td>\n </tr>\n <tr>\n <td>\n Tanzania</td>\n <td>\n 01 Mar 2022</td>\n <td>\n 1</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n The regulatory authority has not halted the conduct of the study in any country.</p>\n
      • estimated_duration7 years 2 months day
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states17
      • number_of_sites5
      • multi_country_listColombia, Egypt, France ,Germany, Ghana, Italy ,Kenya, Lebanon ,Nigeria, Oman ,Saudi Arabia, Tanzania ,United Republic of\nTurkey, United Kingdom, United States ,Zambia
      • data_monitoring_committeeYes
      • total_enrolment_per_siteIt is competitive enrollment world wide. Participants who were enrolled in GBT2104-131 and GBT2104-132 will be given a chance to join the open label study if they consent.
      • total_participants_worldwide520
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyadolescents from 12years to 17 years however they will assent to be in the study and their parents/legal representative will consent for them to join the study
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_nameN
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI-CRDR , Kenyatta National Hospital
      • investigator1_telephone +254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsThe sample size is approximately 520 participants and is based on the combined sample sizes from the originating studies.\n
      • notification<p>\n List of Competent Authority V 2.7 Dated 06 Apr 2022</p>\n
      • approval_date31-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted07-04-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been fully addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 11:31:10
      • created2022-03-31 12:59:46
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id814
        • application_id1135
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMedical Doctor
        • professional_addressStrathmore University Medical Centre
        • telephone +254 733812613
        • emailogutu6@gmail.com
        • created2022-03-31 13:01:39
        • modified2022-04-07 18:44:02
      • 1(array)
        • id815
        • application_id1135
        • given_nameFredrick
        • middle_nameAsirwa
        • family_nameChite
        • qualificationInternal Medicine Physician and Medical Oncologist & Hematologist
        • professional_addressDivision of Hematology and Oncology International Cancer Institute (ICI) P.O. Box 8088 – 30100, Eldoret – Kenya
        • telephone+254700522149.
        • emailchiteasirwa@gmail.com and chite@intercancer.
        • created2022-04-01 08:14:48
        • modified2022-04-07 18:44:02
      • 2(array)
        • id816
        • application_id1135
        • given_nameProf Jessie
        • middle_nameN
        • family_nameGithanga
        • qualificationHaematologist/Clinical pathologist
        • professional_addressGertrude’s Children’s Hospital, 34 Muthaiga road,
        • telephone+254721245721
        • emailjgithanga3@gmail.com
        • created2022-04-01 08:14:48
        • modified2022-04-07 18:44:02
      • 3(array)
        • id817
        • application_id1135
        • given_nameVidelis
        • middle_name N
        • family_nameNduba
        • qualificationMedical Doctor
        • professional_addressKEMRI-CRDR , Kenyata National Hospital
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-04-01 08:14:48
        • modified2022-04-07 18:44:02
    • SiteDetail(array)
      • 0(array)
        • id1269
        • application_id1135
        • county_id47
        • site_nameStrathmore University Medical Centre
        • physical_addressStrathmore University Medical Centre,Ole Sangale Rd
        • contact_details +254733813613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-03-31 13:01:39
        • modified2022-04-07 18:44:02
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1270
        • application_id1135
        • county_id27
        • site_nameInternational Cancer Institute (ICI)-Eldoret
        • physical_addressInternational Cancer Institute, Nandi Road, Block 8/553
        • contact_detailsTel:+254700522149, P.O. Box 8088 – 30100, Eldoret – Kenya,
        • contact_personProf. Fredrick Chite Asirwa
        • site_capacity(null)
        • misc(null)
        • created2022-04-01 09:19:36
        • modified2022-04-07 18:44:02
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 2(array)
        • id1271
        • application_id1135
        • county_id47
        • site_nameKEMRI/CRDR
        • physical_addressKenyatta National Hospital Off Hospital Road, CRDR.
        • contact_detailsTel:+254790484654, P.O Box 47855-00100
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-04-01 09:19:36
        • modified2022-04-07 18:44:02
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1272
        • application_id1135
        • county_id41
        • site_nameKEMRI Siaya Clinical Research Annex
        • physical_addressKEMRI Clinical research Annex,Siaya County Hospital,
        • contact_detailsTel: +254722205901, P.O Box 144-40600.
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-04-01 09:19:36
        • modified2022-04-07 18:44:02
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 4(array)
        • id1273
        • application_id1135
        • county_id47
        • site_nameGertrude’s Children’s Hospital.
        • physical_addressGertrude’s Children’s Hospital-Muthaiga
        • contact_detailsTel:+254 721245721,34 Muthaiga Road,
        • contact_personProf.Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2022-04-01 09:19:36
        • modified2022-04-07 18:44:02
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id587
        • application_id1135
        • sponsorGlobal Blood Therapeutics, Inc.
        • sponsor_typeIndustry
        • contact_personKalyan Obalampalli
        • address181 Oyster Point Blvd.South San Francisco CA 94080 United States
        • telephone_number001 916 284 0777
        • fax_numberN/A
        • cell_number001 916 284 0777
        • email_addresskobalampalli@gbt.com
        • created2022-03-31 13:01:39
        • modified2022-04-07 18:44:02
  • 1(array)
    • Application(array)
      • id1147
      • user_id693
      • trial_status_id6
      • abstract_of_study<div>\n <strong>Introduction</strong></div>\n<div>\n  </div>\n<div>\n Sickle cell disease is one of the most commonly inherited blood disorders in the world characterized by vaso-occlusive crises, anemia, stroke and multiple organ damage. Vaso-occlusive crises are the most common presentation of sickle cell disease. Vaso-occlusive crises are caused by activation of the endothelial cells, neutrophils, monocytes and platelets by the sickled red blood cells. The activation of these cells leads to their expression of the p-selectin molecule promoting the aggregation and adhesion of these cells to one another and to the endothelial cells leading to clot formation and blockage of the microvascular channels.</div>\n<div>\n  </div>\n<div>\n <div>\n There is only one known cure of sickle cell disease, which is a hematopoietic stem cell transplant (HSCT). Unfortunately, this intervention is not easily accessible to most patients due to its cost and unavailability in the country. Most patients with sickle cell disease are therefore mainly on supportive treatment. These reasons inform the need for more affordable and accessible treatments.</div>\n <div>\n  </div>\n <div>\n <div>\n The study participants will have completed a study of inclacumab (originating study) and will receive inclacumab intravenous infusion in this open-label study. They will receive the intravenous treatment every 12 weeks. The mechanism of action of inclacumab is to prevent the action of p-selectin molecule, which reduces adhesion of molecules and leads to a reduction in the episodes of vaso-occlusive crises. The study aims to assess the safety of long-term administration of inclacumab in participants with SCD that have completed an inclacumab clinical trial. During the study period, participants can receive standard of care treatment except for crizanlizumab.</div>\n <div>\n  </div>\n <div>\n <strong>Methodology</strong></div>\n <div>\n  </div>\n <div>\n <strong>Study setting</strong></div>\n <div>\n The study will be carried out in up to 150 global clinical sites with a sample size of 520 participants. There will be approximately 5 sites in Kenya. We have three study sites in different parts of Nairobi, one in Siaya and the last one in Eldoret.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Study design</strong></div>\n <div>\n This study is an open-label extension study to evaluate the safety of long-term treatment with inclacumab in participants with SCD. The study will be available to eligible participants who were enrolled in a prior GBT-Sponsored inclacumab clinical study (originating study). Eligible participants, who continue to receive clinical benefit that outweighs risk, will receive inclacumab every 12 weeks until the participant has access to inclacumab from an alternative source. Given the long half-life of inclacumab (terminal half-life of 21 to 28 days) at the dose to be evaluated in this study, the majority of participants receiving active study drug are expected to maintain target concentrations as required throughout the study period.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>INTRODUCTION & JUSTIFICATION</strong></div>\n <div>\n Sickle cell disease is one of the most commonly inherited blood disorders worldwide (Sj et al., 2017). It is estimated that approximately 300,000 children are born with sickle cell disease in the world annually, 75% of whom are from Sub-Saharan Africa (Makani et al., 2013). As there is no systematic neonatal screening program in most public and private facilities, there is no national prevalence data. However, it is estimated that 4% of children born in Western Kenya have sickle cell disease (Wanjiku et al., 2019). The study is being conducted in Kenya due to the high incidence of sickle cell disease in the country.</div>\n <div>\n  </div>\n <div>\n <div>\n Sickle cell disease (SCD) is an autosomal recessive disease characterized by chronic haemolysis, inflammation and vaso-occlusion presenting as recurrent pain episodes (variously termed sickle cell-related pain crises or VOCs), multi-organ dysfunction, and early death (Kato, 2018).</div>\n <div>\n <div>\n Vaso-occlusion in SCD is driven by a series of complex and often redundant receptor–ligand interactions involved in the adhesion of circulating cells to the damaged</div>\n <div>\n endothelium and exposed sub-endothelium. Extensive research demonstrates that P-selectin mediated cellular interactions with sickled red blood cells (RBCs), leukocytes and platelets play a crucial role in the pathophysiology of vaso-occlusion in SCD. Blocking P-selectin-mediated cellular interactions reduces vaso-occlusion in animal models. Taken together, these data led to the hypothesis that blocking P-selectin could reduce the risk of VOCs in SCD patients.</div>\n <div>\n  </div>\n <div>\n <div>\n Results from a randomized, placebo-controlled Phase 2b trial of crizanlizumab, a humanized monoclonal antibody in SCD, bolstered the hypothesis that blocking the</div>\n <div>\n interaction of P-selectin with its receptors could prevent vaso-occlusion and VOCs (Ataga, 2017). In summary, there is a high unmet need for treatment options in SCD and there is a scientific rationale, supported by clinical data, that p-selectin inhibition has the potential to reduce the risk for acute vaso-occlusions.</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n <strong>JUSTIFICATION/RATIONALE</strong></p>\n<div>\n Allogeneic HSCT remains the only curative therapy for sickle cell disease. It is however unavailable for most patients due to its high cost and it being available only in high income countries. It is also associated with various transplant complications (Kassim and Sharma 2017). Three therapies, hydroxyurea (HU [DROXIA®, 2017]; (also known as hydroxycarbamide), L-glutamine (ENDARI, 2017) and crizanlizumab (ADAKVEO®, 2019), have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to reduce VOCs in patients with SCD (Charache, 1995; Niihara, 2018; Ataga, 2017). The effectiveness of HU is impaired by low compliance rates and frequent discontinuations in treatment (Shah, 2019) while L-glutamine provides a modest 25% reduction in annual VOC rates (Niihara, 2018).</div>\n<div>\n  </div>\n<div>\n Crizanlizumab is a monoclonal antibody directed against human P-Selectin and is administered as an infusion every 4 weeks whereas inclacumab is to be administered every 12 weeks. The 4-week administration of crizanlizumab is a potential barrier to continued adherence to lifelong therapy because patients need to travel more frequently to an infusion centre to receive treatment. This regimen extracts a higher cost on patient and caregiver productivity and frequent intravenous infusions generally attract extra costs to the patient. (Saini, 2009; Richter, 2003). It has also been shown that less frequent dosing results in better adherence to medication (Saini, 2009; Richter, 2003).</div>\n<div>\n  </div>\n<div>\n <div>\n Inclacumab has a similar mechanism of action as crizanlizumab. Previous studies on inhibition of p-selectin through crizanlizumab, have demonstrated it to be efficacious and safe for use in SCD patients. Additionally, the dose selected is 30mg/kg every 12 weeks and from previous studies, population PK simulations project that the inclacumab dose regimen of 30 mg/kg Q12W will maintain concentrations above 10 μg/mL throughout the study period in the majority of participants, thereby maximizing the pharmacology required for effective reduction of VOC in the SCD population. The 12-week dosing for inclacumab offers a potential benefit over the 4-week dosing of crizanlizumab and this could increase patient adherence to treatment, reduce the costs of patient and caregiver productivity, leading to a reduction in the overall health costs. Treatments with stable standard of care are allowed except for crizanlizumab because it has a similar mechanism of action as the study drug and would confound the interpretation of this data.</div>\n <div>\n  </div>\n <div>\n <div>\n In summary, despite the recent availability of new options to treat VOCs, an unmet medical need exists to further reduce the frequency of VOCs while reducing patient burden and enhancing patient adherence to therapy.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>NULL HYPOTHESIS</strong></div>\n <div>\n  </div>\n <div>\n There is no null hypothesis.</div>\n <div>\n  </div>\n <div>\n <strong>OBJECTIVES</strong></div>\n <div>\n <strong>Primary objective</strong></div>\n <div>\n 1. To evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD that have completed a prior inclacumab clinical trial.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Additional objectives</strong></div>\n <div>\n 2.To evaluate the incidence of VOCs, hospitalizations, missed work/school days, RBC transfusions, and quality of life (QoL) with long-term use of inclacumab.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>STUDY DESIGN</strong></div>\n <div>\n This study is a multicenter, global, open-label extention, designed to assess the safety of long-term treatment with inclacumab in participants with SCD.</div>\n <div>\n  </div>\n <div>\n <div>\n Participants must have completed participation in their originating clinical study and must meet the entry criteria for this study to be eligible for enrolment. Eligible</div>\n <div>\n participants will receive Inclacumab 30 mg/kg administered IV Q12W; if they continue to receive clinical benefit that outweighs the risk, until the participant has access to inclacumab from an alternative source (e.g., through commercialization or a managed-access program).</div>\n <div>\n  </div>\n <div>\n <div>\n All participants will undergo safety and outcome assessments at Baseline (Day 1), Week 6, and every 12 weeks thereafter. Visits to the clinical site for infusion of study drug will occur at Baseline (Day 1) and every 12 weeks (Weeks 12, 24, 36, 48, etc.).</div>\n <div>\n  </div>\n <div>\n <div>\n Despite this being an open-label study, Investigators, study site staff, the Sponsor’s study staff, the Sponsor’s clinical CRO, and study participants will remain blinded to the randomized treatment assignments, as applicable, from the originating GBT-Sponsored inclacumab study. During the study, access to participants’ treatment assignment from the originating study will be limited to DMC members and service providers supporting DMC reviews, including the independent Data Coordinating Centre, until the database from the originating study is locked and primary endpoint analysis is complete. If a need arises for unblinding of the originating GBT-Sponsored inclacumab study, the instruction for unblinding as outlined in the originating study protocol will be followed.</div>\n <div>\n  </div>\n <div>\n <div>\n A Data Monitoring Committee (DMC) will regularly review the totality of accumulated safety data from all ongoing inclacumab studies on an ongoing, unblinded basis with additional emphasis on adolescent participants. DMC review will continue until the originating studies have been completed and the randomization assignments are unblinded. Details will be provided in the DMC Charter.</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • study_title<div>\n An Open-Label Extension Study to Evaluate the Long-Term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial</div>\n
      • laymans_summary<div>\n Sickle cell disease is an inherited blood disorder that causes frequent pain episodes, and multiple organ complications. Currently, there is only one known cure for sickle cell disease which is a bone marrow transplant that is inaccessible for most Kenyans. However, currently most patients are usually on treatments that help control the disease e.g. hydroxyurea and folic acid, or prevent infections e.g. palludrine and Penicillin V, or manage symptoms as they arise e.g. painkillers for pain episodes and blood transfusion for anemia. There is a need for new treatments that help improve the patients’ quality of life.</div>\n<div>\n <div>\n Pain episodes are mainly caused by the blockage of blood flow to various parts of the body. One of the causes of this blockage includes formation of clots in the blood vessels. A molecule called p-selectin; produced by our bodies contributes to formation of this clots. GBT has developed a drug called inclacumab that prevents the function of p-selectin leading to a reduction in the formation of clots bringing about an overall decrease in pain episodes. The main aim of this study is to assess whether inclacumab is safe for use and if it reduces the number of vaso occlusive crises in patients with sickle cell disease when administered long-term.</div>\n <div>\n <div>\n A total of 520 participants will be enrolled across 150 clinical sites globally. There will be about 5 sites in Kenya. 3 sites are in Nairobi 1 in Siaya and another one in Eldoret. The sites will enrol this participants following their participation in and receipt of inclacumab in another GBT-sponsored inclacumab clinical study.</div>\n <div>\n Participation in the study is voluntary and those enrolled have the possibility of benefiting from the study. If the drug proves to be efficacious there may be a reduction in the number of pain episodes. Additionally, participants will receive education on the disease. Participation in the study may also benefit health care workers and the local community who are actively involved with sickle cell disease management by providing more information on the treatment of the disease.</div>\n <div>\n <div>\n There are potential risks associated with participation in the study and are mainly related to the side effects of the investigational product including but not limited to</div>\n <div>\n diarrhoea, vomiting, tiredness, nasal congestion, common cold symptoms and pain in the mouth and throat. Participants will be monitored for any side effects or sickness and if unwell treatment will be provided.</div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • short_titleGBT Open Label inclacumab Ph3
      • protocol_noECCT/22/08/01
      • version_noOriginal (V1.0)
      • date_of_protocol30-03-2021
      • study_drugInclacumab: Prof Githanga GBT2104-133
      • disease_conditionSickle Cell Disease
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameN/A
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantMillicent Aketch
      • declaration_date102-08-2022
      • declaration_principal_investigatorDr. Videlis Nduba
      • declaration_date202-08-2022
      • placebo_presentNo
      • study_objectives<div>\n <strong>Main Objective</strong></div>\n<div>\n The primary objective of this study is to:</div>\n<div>\n  </div>\n<div>\n 1. Evaluate the long-term safety of every 12 week dosing of inclacumab in participants with sickle cell disease (SCD) that have completed a prior inclacumab clinical trial.</div>\n<div>\n  </div>\n<div>\n <strong>The secondary Objective</strong></div>\n<div>\n Additional objectives are to:</div>\n<div>\n  </div>\n<div>\n 1. Evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab.</div>\n
      • principal_inclusion_criteria<div>\n 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study.</div>\n<div>\n 2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.</div>\n<div>\n 3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study.</div>\n<div>\n 4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug.</div>\n<div>\n 5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement.</div>\n
      • principal_exclusion_criteria<div>\n 1. Female participant who is breastfeeding or pregnant.</div>\n<div>\n 2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study.</div>\n<div>\n 3. Participant withdrew consent from the originating inclacumab clinical study.</div>\n<div>\n 4. Participant was lost to follow-up from the originating inclacumab clinical study.</div>\n<div>\n 5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.</div>\n
      • primary_end_points<p>\n Not applicable</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n <strong>Gertrude’s Children’s Hospital Site:</strong></div>\n<div>\n  </div>\n<div>\n Gertrude’s Children’s Hospital (GCH) is one of the largest hospital in East and Central Africa dedicated exclusively to the care of children. For over 60 years, the hospital has provided high standards of paediatric care for children from birth to 21 years of age. The hospital is accredited by the Joint Commission International Accreditation and Safe Care, Netherlands following audits of the hospital facilities.</div>\n<div>\n  </div>\n<div>\n <div>\n GCH is a non-profit organization, chartered with the responsibility of provision of health services, fostering good health, carrying out research and teaching healthcare professionals. Based in Muthaiga, Nairobi, and spread out to various outpatient clinics all over Nairobi and in several other Counties, the hospital attends to over 300,000 children as outpatients and admits over 6,000 patients on average per year.</div>\n <div>\n  </div>\n <div>\n <div>\n The over 100-bed hospital offers comprehensive paediatric medical services and there are 21 specialist clinics that cover almost every aspect of paediatric healthcare from haematology, chest conditions, cardiology, dermatology, otorhinolaryngology, endocrinology, oncology and HIV/AIDS. Primary care services are also offered including a Well Baby and Immunization clinic.</div>\n <div>\n  </div>\n <div>\n <div>\n The laboratory is equipped with modern equipment and offers diagnostic laboratory testing in all areas of pathology and is headed by a pathologist supported by several other pathologists, laboratory manager and qualified medical laboratory technologists. The hospital laboratory and pharmacy cater for both children and adults. The laboratory is accredited by Kenya Accreditation Service as a medical testing laboratory (ISO15189:2012). Qualified pharmacists manage the hospital pharmacy.</div>\n <div>\n GCH has an up-to-date paediatric imaging facility that is managed by a team of radiologists and qualified radiographers. Most of the processes at the hospital are fully computerized and supported by a well-integrate Information Technology Department. The main hospital in Muthaiga is open 24/7 and offers 24-hour laboratory and pharmacy coverage. The Accident and Emergency Department is well equipped to deal with all forms of paediatric emergencies and has a crash cart and crash</div>\n <div>\n team on call, 24 hours a day. There are registered nurses, medical officers and specialists specifically trained in Emergency Triage Assessment and Treatment. The Team is fully trained to handle emergencies, including but not limited to airway obstruction and other breathing problems; circulatory impairment or shock; severely altered central nervous system function (coma or convulsive seizures); and severe dehydration which require urgent appropriate care to prevent death. The Hospital</div>\n <div>\n runs an Institute of Child Health and Research based at the Muthaiga site which is approved by the Nursing Council of Kenya. The school offers courses in paediatric endocrinology, paediatric phlebotomy, emergency paediatric medicine and several specialised paediatric nursing courses. The Hospital has an Ethics Review Committee (ERC) that acts independently from the appointing authority, hosting institution, researchers, sponsors and any other stakeholders in its review and decision-making processes. The ERC is accredited by the National Commission for Science and Technology and Innovation (NACOSTI), an institution mandated to advise the Government on policies and matters relating to the scientific and technological activities and research required for the proper development of the country. The population served by the hospital is cosmopolitan and English and Kiswahili are the predominantly spoken languages.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Site Study Staff Details</strong></div>\n <div>\n The site has a multidisciplinary study team that comprises specialists and professionals in many fields of medicine including; medical officers, paediatricians, haematologists, oncologists, pathologists, nurses, pharmacists, medical laboratory technologists. The Team has members who have been trained on the job as study coordinators. The team members are experienced in clinical trials and have all been trained in Good Clinical Practice and most have successfully participated in several other clinical trials.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Site personnel roles and responsibilities</strong></div>\n <div>\n  </div>\n <div>\n <strong>Principal Investigator</strong> • Prof Jessie Githanga A qualified haematologist/clinical pathologist, registered by the Kenya Medical Practitioners and Dentists Council (KMPDC). She will be responsible for the overall conduct of the trial at the study site, budgetary negotiations, administrative actions and communication between Institutional Review Boards, and the sponsor and oversight of patient care. She will oversee the recruitment of the subjects and directly supervise study staff.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Co-Investigator/main coordinator </strong>• Dr. Doreen Karimi Mutua A qualified paediatrician, with subspecialty training in paediatric haemato-oncology working at GCH and registered by the KMPDC. Dr Mutua will be responsible for clinical care provision of the patients, assist in supervision of study staff and will also participate in study recruitment. Dr Mutua supports PI and has roles that may be delegated such as ethical and sponsor communication and may be delegated related roles.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Study Coordinator</strong> • Dr Joy Githua A qualified medical officer, registered by the KMPDC working at GCH. She will be the main coordinator for the study and will be responsible for day to day management of trial aspects including participant recruitment, follows up, safety monitoring, data entry and maintaining the site files and other study records and may be delegated related roles.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Study Pharmacist and assistant</strong>:</div>\n <ul>\n <li>\n Dr Samuel Madere (pharmacist) • Crecencia Nekesa Makokha (pharmaceutical technologist) Qualified pharmacist, registered by the Pharmacy and Poison’s Board (PPB), will be delegated roles of the IP storage and related duties, dilution of IP and dispensing, processing of import permit for IP and may be delegated related roles. He will be assisted by a pharmaceutical technologist.</li>\n </ul>\n <div>\n <strong>Study nurses: </strong>• Hannah Wanjiku (assistant study coordinator) • Felicity Kamundi • Jane Nduati A registered nurse, registered by the Nursing Council of Kenya, will be responsible for co-ordinating the patient visits, taking patent vital signs and patient training. The assistant study coordinator will in addition be the assistant study coordinator.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Laboratory Manager:</strong> Peninah Chege: Laboratory manager registered by the Kenya Medical Laboratory Technologists and Technicians Board (KMLTTB) will coordinate laboratory functions, process the import permits for laboratory items, equipment and may be delegated related roles.</div>\n <div>\n <div>\n <strong>Laboratory technologist/phlebotomist</strong> • Charles Muia (technologist) • Herman Akumu(technologist) • Joseph Langat (phlebotomist) Trained laboratory technologists registered by the KMLTTB and trained in Good Clinical Practice (GCP) and phlebotomist who will obtain specimens from study participants. The technologists will perform any local laboratory testing where necessary and package specimens for shipping to Central or other local labs.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Quality Assurance Officer</strong> • Winnie Abuto Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and GCP trained. She will be tasked with ensuring that study documents are quality controlled so that they are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) in accordance GCP guidelines. She will ensure that staff are alerted to changes in standard operating procedures (SOPs) as necessary.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Administrative assistant </strong>• Truphena Otinyo The Administrative assistant will coordinate and maintain the records of communications with the ERC, assist the main coordinator in patient visit coordination. She may be delegated related roles.</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<div>\n  </div>\n<div>\n <strong>Kisumu/Siaya</strong></div>\n<div>\n  </div>\n<div>\n Site Site activities are located in Kisumu/Siaya and Nairobi Counties. Kisumu hosts the main IP storage site, administrative offices of the PI and co-investigators, procurement and Human Resource functions are housed at the KEMRI Kisian Campus. Recruitment, follow-up of study participants will occur in Siaya.</div>\n<div>\n  </div>\n<div>\n <div>\n KEMRI has a modern research annex at the Siaya county hospital with capacity to conduct phase I to Phase III studies. After community mobilization, screening and enrollment, IP dispensation will occur at the Siaya Clinical Research Annexe.</div>\n <div>\n  </div>\n <div>\n <div>\n Site investigators responsible for day to day running of the project include: Medical Officer 2, Pharmacist 1, Pharm tech 2, Nurses 5, Quality Assurance Officer 2, Quality Control 1, Clinical Officer 2, Community Interviewers 4.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>KEMRI/CRDR clinical research Site</strong></div>\n <div>\n  </div>\n <div>\n Site activities will take place within the KEMRI/CRDR clinical research annex. This facility has several clinical rooms available for consenting, nursing procedures, clinical exams and dosing. There are also additional facilities that include an inpatient ward, staff work areas and a monitoring space, a pharmacy, laboratory and kitchen for preparing participant meals.</div>\n <div>\n  </div>\n <div>\n Site staff include the principal investigator, 4 medical officers, 2 pharmacists, 1 pharmtech, 5 nurses, 5 quality assurance officers, 3 clinical officers and 6 community health workers.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>International Cancer Institute-Eldoret</strong></div>\n <div>\n  </div>\n <div>\n The Investigator (PI) has adequate staff and have the necessary time,capacity and availability to conduct the study, including site management, collection, processing and shipment of lab samples. Below is the list of the staff at the site:</div>\n <div>\n - Dr Fredrick Chite -PI - Joyce Chizi Kiti- Medical officer - Mercy Cherop-Biostatistician - Hildah Kaziga Chavera- Medical Officer -</div>\n <div>\n Collins Saina- Pharmacist - David Wambasi-Nurse - Stephen Karuru-Data manager - George Gitau Thumbi-Laboratory</div>\n <div>\n Technologist</div>\n <div>\n  </div>\n <div>\n <div>\n The site is in a spacious compound and has 5 building. The main clinic buildings, the Pharmacy, laboratory, an office for the study Coordinator and additional personnel (essential documents are stored in a locked cabinet in this office). The main administrative building has individual work space, the Investigators office, a reception area, ablution blocks and individual works space cabins. The site has an access-controlled pharmacy, with shelving for storage of IP and non-IP products. There are consultation rooms, a nursing station with emergency equipment which also serves as a reception area and a procedure room.</div>\n <div>\n  </div>\n <div>\n <div>\n The clinic is fully equipped to handle emergencies and the site has a 5-bed additional bed capacity that can be used as a temporary inpatient facility. The clinic also has a counselling room which will be used for the consenting process. Each consultation room is equipped with a desk, computer which is video enabled, a lamp, an examination couch, a trolley, a wooden lockable cabinet for supplies, equipment required to perform examinations e.g. sphygmomanometer, stethoscopes and several other scopes, blood collection tools e.g tourniquets. The site will outsource Xray services and laboratory services that require an accredited laboratory to Lancet laboratories. The site has a high-speed internet.</div>\n <div>\n  </div>\n <div>\n <div>\n <strong>Strathmore University Medical Centre (SUMC) Site</strong></div>\n <div>\n  </div>\n <div>\n The SUMC is designed for clinical trials and has a full clinical laboratory with bioanalytical capability. The Centre is managed</div>\n <div>\n by Strathmore University and the CREATES consortium. The Centre also has a dental unit.</div>\n <div>\n  </div>\n <div>\n <div>\n The medical centre is staffed by 2 pediatricians, 2 physicians, 1 medical officer, 1 clinical officer, 4 dental surgeons, 3 psychologists, 1 pharmacist, 1 visiting psychiatrist, 1 physician assistant, 4 nurses and 4 laboratory technologists. The facility supports healthcare to university students and staff and also general public. The centre currently runs a SCD clinic every Tuesday.</div>\n <div>\n  </div>\n <div>\n <div>\n Location The Sickle Cell study will be conducted at SUMC; recruitment will occur at the clinic. SUMC is located at Strathmore University in Madaraka Estate of Nairobi west, Nairobi County. SUMC will be staffed by qualified research personnel from KEMRI and SUMC. The site has a pharmacy, treatment area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done. SUMC currently runs a SCD clinic with more than 200 patients on follow up comprising of both adults and children.</div>\n <div>\n  </div>\n <div>\n <div>\n Provision of medical care SUMC is an outpatient facility with a 2-bed holding unit and a separate emergency resuscitation area. The centre serves as a clinical trials facility for both paediatric and adult studies. The participants who will require inpatient care will be admitted to Coptic Hospital Ngong Road as SUMC already has an existing working arrangement. As for the Sickle cell disease, there is a database in place that has over 200 patients and we hope to base our recruitment on this list.</div>\n <div>\n The SUMC is also linked to other private, government, non-governmental and county health facilities, in Nairobi County that take care of patients with SCD. For the care of sickle cell patients, the SCD clinic will work closely with the study team.</div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A, trial is being conducted in USA</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:207px;\">\n <p>\n <strong>Country </strong></p>\n </td>\n <td style=\"width:207px;\">\n <p>\n <strong>Date submitted</strong></p>\n </td>\n <td style=\"width:207px;\">\n <p>\n <strong>Status</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n France</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 20 Sep2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Kenya</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 23 Feb 2022</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Nigeria</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 25 May 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Ghana</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 27 Aug 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n Pending</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:207px;\">\n <p>\n <strong>Country </strong></p>\n </td>\n <td style=\"width:207px;\">\n <p>\n <strong>Date Approved</strong></p>\n </td>\n <td style=\"width:207px;\">\n <p>\n <strong>Number of sites</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Germany</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 10 Nov 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Italy</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 04 Aug 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Brazil</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 29 Jun2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 6</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Colombia</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 29 Nov 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Egypt</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 01 Sep 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 8</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Saudi Arabia</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 08 Dec 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 2</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Turkey</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 26 Dec 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n United Kingdom</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 27 Oct 2021</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Unites States of America</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 11 Dec 2020</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 25</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Zambia</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 11 Jan 2022</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 3</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Kenya</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 22 Mar 2022</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 1 out of 5 sites approved</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:207px;\">\n <p>\n Tanzania</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 01 Mar 2022</p>\n </td>\n <td style=\"width:207px;\">\n <p>\n 1</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n The regulatory authority has not halted the conduct of the study in any country.</p>\n
      • estimated_duration7 years 2 months day
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states17
      • number_of_sites5
      • multi_country_listColombia, Egypt, France ,Germany, Ghana, Italy ,Kenya, Lebanon ,Nigeria, Oman ,Saudi Arabia, Tanzania ,United Republic of Turkey, United Kingdom, United States ,Zambia
      • data_monitoring_committeeYes
      • total_enrolment_per_siteIt is competitive enrollment world wide. Participants who were enrolled in GBT2104-131 and GBT2104-132 will be given a chance to join the open label study if they consent.
      • total_participants_worldwide520
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyAdolescents from 12years to 17 years however they will assent to be in the study and their parents/legal representative will consent for them to join the study
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameVidelis
      • investigator1_middle_nameN
      • investigator1_family_nameNduba
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI-CRDR , Kenyatta National Hospital
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participantsThe sample size is approximately 520 participants and is based on the combined sample sizes from the originating studies.
      • notification
      • approval_date19-10-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-08-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonAll reviewer queries have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 11:29:40
      • created2022-05-16 09:34:43
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id821
        • application_id1147
        • given_nameProf Jessie
        • middle_nameN
        • family_nameGithanga
        • qualificationHaematologist/Clinical pathologist
        • professional_addressGertrude’s Children’s Hospital, 34 Muthaiga road,
        • telephone+254721245721
        • emailjgithanga3@gmail.com
        • created2022-05-16 09:36:59
        • modified2022-08-02 20:03:43
      • 1(array)
        • id823
        • application_id1147
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMedical Doctor
        • professional_addressStrathmore University Medical Centre
        • telephone+254 733812613
        • emailogutu6@gmail.com
        • created2022-05-16 15:56:43
        • modified2022-08-02 20:03:43
      • 2(array)
        • id824
        • application_id1147
        • given_nameFredrick
        • middle_nameAsirwa
        • family_nameChite
        • qualificationInternal Medicine Physician and Medical Oncologist & Hematologist
        • professional_addressDivision of Hematology and Oncology International Cancer Institute (ICI) P.O. Box 8088 – 30100, Eldoret – Kenya
        • telephone+254700522149
        • emailchiteasirwa@gmail.com and chite@intercancer
        • created2022-05-16 15:56:43
        • modified2022-08-02 20:03:43
      • 3(array)
        • id825
        • application_id1147
        • given_nameVidelis
        • middle_nameN
        • family_nameNduba
        • qualificationMedical Doctor
        • professional_addressKEMRI-CRDR , Kenyata National Hospital
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-05-16 16:02:55
        • modified2022-08-02 20:03:43
    • SiteDetail(array)
      • 0(array)
        • id1277
        • application_id1147
        • county_id47
        • site_nameGertrude’s Children’s Hospital
        • physical_addressGertrude’s Children’s Hospital-Muthaiga
        • contact_detailsTel:+254 721245721,34 Muthaiga Road,
        • contact_personProf.Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2022-05-16 09:36:59
        • modified2022-08-02 20:03:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1279
        • application_id1147
        • county_id47
        • site_nameStrathmore University Medical Centre
        • physical_addressStrathmore University Medical Centre,Ole Sangale Rd
        • contact_details+254733813613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
        • misc(null)
        • created2022-05-16 16:20:20
        • modified2022-08-02 20:03:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id1280
        • application_id1147
        • county_id27
        • site_nameInternational Cancer Institute (ICI)-Eldoret
        • physical_addressInternational Cancer Institute, Nandi Road, Block 8/553
        • contact_detailsTel:+254700522149, P.O. Box 8088 – 30100, Eldoret – Kenya,
        • contact_personProf. Fredrick Chite Asirwa
        • site_capacity(null)
        • misc(null)
        • created2022-05-16 16:21:24
        • modified2022-08-02 20:03:43
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 3(array)
        • id1281
        • application_id1147
        • county_id47
        • site_nameKEMRI/CRDR
        • physical_addressKenyatta National Hospital Off Hospital Road, CRDR.
        • contact_detailsTel:+254790484654, P.O Box 47855-00100
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-05-16 16:22:43
        • modified2022-08-02 20:03:43
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1282
        • application_id1147
        • county_id41
        • site_nameKEMRI Siaya Clinical Research Annex
        • physical_addressKEMRI Clinical research Annex,Siaya County Hospital,
        • contact_detailsTel: +254722205901, P.O Box 144-40600.
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-05-16 16:23:34
        • modified2022-08-02 20:03:43
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
    • Sponsor(array)
      • 0(array)
        • id591
        • application_id1147
        • sponsorGlobal Blood Therapeutics, Inc.
        • sponsor_typeIndustry
        • contact_personKalyan Obalampalli
        • address181 Oyster Point Blvd.South San Francisco CA 94080 United States
        • telephone_number001 916 284 0777
        • fax_numberN/A
        • cell_number001 916 284 0777
        • email_addresskobalampalli@gbt.com
        • created2022-05-16 09:36:59
        • modified2022-08-02 20:03:43
  • 2(array)
    • Application(array)
      • id495
      • user_id77
      • trial_status_id5
      • abstract_of_study<p>\n This is a phase II open-label, single arm, multicenter, steady-state pharmacokinetic (PK) study of drug-drug interactions in Human Immunodeficiency Virus (HIV) infected women treated with depot medroxyprogesterone acetate (DMPA) while receiving an efavirenz (EFV)-based combination antiretroviral therapy (cART), rifampicin (RIF) and isoniazid (INH) during the treatment of active tuberculosis (TB). The objectives of this study are to estimate the optimal dosing frequency of depot medroxyprogesterone acetate (DMPA) for HIV and TB coinfected women taking EFV-based cART and RIF-containing TB treatment based on a target MPA concentration >0.1 ng/mL and to determine whether a 150 mg DMPA IM injection will be adequate to suppress ovulation through 12 weeks in women taking EFV-based cART and RIF-containing TB treatment based on serial plasma progesterone concentrations. Premenopausal women 18 to 46 years of age who are co-infected with HIV and TB and are on EFV plus two or more nucleoside reverse transcriptase inhibitors (NRTIs) for at least 4 weeks and intend to continue on this regimen without modifications for the duration of the study will participate. The women must also be on the continuation phase of active TB treatment taking RIF and INH on a 5-day or more per week schedule. Blood samples for DMPA PK analysis will be collected at pre-dose and every 2 weeks post DMPA administration. Progesterone levels will be tested every 2 weeks post DMPA administration. Depot medroxyprogesterone acetate (DMPA) 150 mg administered intramuscularly (IM) as a single-dose at study entry and an optional dose of DMPA will be available at no cost to all qualifying study participants after all week 12 study evaluations are completed. The sample size will comprise 46 evaluable participants who will be followed for 12 weeks The results of this study, if successful, will help inform the optimal frequency of DMPA injections in HIV/TB co-infected patients.</p>\n
      • study_title<div>\n A5338</div>\n<div>\n An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among</div>\n<div>\n Depot Medroxyprogesterone Acetate (DMPA), Rifampicin (RIF), and Efavirenz</div>\n<div>\n (EFV) in Women Co-Infected with Human Immunodeficiency Virus (HIV) and</div>\n<div>\n Tuberculosis (TB)</div>\n
      • laymans_summary<p>\n Effective contraception is critical to young women with HIV-associated tuberculosis (TB), as unintended pregnancy is associated with increased maternal illness and death. The effects of co-administration of efavirenz and rifampicin on the mechanisms of action of depot medroxyprogesterone acetate (DMPA) are unknown. We hypothesized that clearance of medroxyprogesterone acetate (MPA) would increase when given with rifampicin and efavirenz, thus increasing risk of pregnancies. This pharmacokinetics (PK) study assessed DMPA among HIV/TB coinfected women on an efavirenz-based antiretroviral treatment and rifampicin-based TB treatment. Plasma MPA concentrations and progesterone were measured before dosing (MPA only) and 2, 4, 6, 8, 10, and 12 weeks after a single DMPA 150 mg intramuscular injection. The primary outcome measure, MPA concentration (less than 0.1 ng/mL) at week 12, was assessed and the parameters of MPA mechanism of action were calculated using statistical analysis. Among 42 evaluable women from 5 African countries, median age was 32 years and median CD4 was 414 cells/ mm3. Five women had MPA less than 0.1 ng/mL at week 12; of these, one had MPA less than 0.1 ng/mL at week 10. The median clearance of MPA was 19 681 L/week compared with 12 118 L/week for historical controls. There were no adverse events related to DMPA, and progesterone concentrations were less than 1 ng/mL for all women for the study duration. In conclusions, DMPA when given with rifampicin and efavirenz, was safe. MPA clearance was higher than in women with HIV and not on any Anti-HIV treatment suggesting that more frequent DMPA dosing might be needed.</p>\n
      • short_titleA5338
      • protocol_noECCT/16/05/01
      • version_noVersion 1.0
      • date_of_protocol12-12-2014
      • study_drugDMPA
      • disease_conditionHIV and TB
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones1
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_namemedoxyprogesterone acetate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantElizabeth A. Ayuo
      • declaration_date109-05-2016
      • declaration_principal_investigatorDr. David Schnabel
      • declaration_date209-05-2016
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<div>\n HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or</div>\n<div>\n chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry</div>\n<div>\n and confirmed by a licensed Western blot or a second antibody test by a </div>\n<div>\n <div>\n Currently receiving RIF and Isoniazid (INH)-based TB therapy on at least 5 days</div>\n <div>\n per week schedule after completion of the intensive phase of TB treatment</div>\n <div>\n (minimum of 8 weeks of TB treatment) and expected to be on TB treatment for a</div>\n <div>\n minimum of 12 weeks after enrollment.</div>\n <div>\n 4</div>\n</div>\n<div>\n <div>\n Last menstrual period (LMP) ≤35 days prior to study entry.</div>\n <div>\n 4.1.6.1 If LMP is >35 days prior to study entry, serum follicle-stimulating</div>\n <div>\n hormone (FSH) must be ï‚£40 MIU/mL.</div>\n <div>\n NOTE: Enrollment after the start of the monthly menstrual flow is preferred.</div>\n <div>\n 4.1.7 Negative serum or urine-HCG pregnancy test within 30 days prior to study entry</div>\n <div>\n and negative pregnancy test at entry at any network-approved laboratory that</div>\n <div>\n operates in accordance with Good Clinical Practices and participates in</div>\n <div>\n appropriate external quality assurance programs.</div>\n <div>\n 4.1.8 All participants must agree not to participate in a conception process (eg, active</div>\n <div>\n attempt to become pregnant or in vitro fertilization) for the duration of the study.</div>\n <div>\n Women of reproductive potential, who are participating in sexual activity that</div>\n <div>\n could lead to pregnancy, must agree to use an additional reliable method of</div>\n <div>\n contraception while in the study. Acceptable forms of contraceptives include:</div>\n <div>\n ï‚· Condoms (male or female) with or without a spermicidal agent</div>\n <div>\n ï‚· Diaphragm or cervical cap with spermicide</div>\n <div>\n ï‚· Non-hormonal IUD</div>\n <div>\n ï‚· Bilateral tubal ligation</div>\n <div>\n ï‚· Male partner vasectomy</div>\n <div>\n 4.1.9 Laboratory values within 30 days prior to study entry:</div>\n <div>\n ï‚· Absolute neutrophil count ≥500 cells/mm3</div>\n <div>\n ï‚· Platelet count ≥50,000 platelets/mm3</div>\n <div>\n ï‚· Hemoglobin ≥8.0 g/dL</div>\n <div>\n ï‚· Aspartate transaminase (AST) and alanine aminotransferase (ALT) <5 x</div>\n <div>\n upper limit of normal (ULN)</div>\n <div>\n ï‚· Creatinine ≤1.5 x ULN</div>\n <div>\n ï‚· Total bilirubin ≤2.0 x ULN</div>\n <div>\n  Women between the ages of 18 to 46 years</div>\n <div>\n  Ability and willingness to provide written informed consent</div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<div>\n Receipt of DMPA and any other injectable contraceptives within 180 days prior to</div>\n<div>\n study entry.</div>\n<div>\n 24 A5338</div>\n<div>\n Final Version 1.0</div>\n<div>\n 12/12/14</div>\n<div>\n 4.2.2 Receipt of other hormonal contraceptives within 30 days prior to study entry.</div>\n<div>\n 4.2.3 Use of any drugs other than RIF and EFV known to: 1) induce CYP3A4 system</div>\n<div>\n within 30 days and to 2) inhibit the CYP3A4 system with one week prior to study</div>\n<div>\n entry.</div>\n<div>\n 4.2.4 ≤40 kg in weight.</div>\n<div>\n 4.2.5 Bilateral oophorectomy.</div>\n<div>\n 4.2.6 Less than 30 days postpartum at study entry.</div>\n<div>\n 4.2.7 Hypersensitivity to DMPA, MPA, or any of the other ingredients in DMPA.</div>\n<div>\n 4.2.8 Breast cancer.</div>\n<div>\n 4.2.9 Serious illness requiring systemic treatment and/or hospitalization within 21 days</div>\n<div>\n prior to study entry.</div>\n<div>\n 4.2.10 Karnofsky performance score <70 within 14 days prior to study entry.</div>\n<div>\n 4.2.11 Use of any immunosuppressant medication including systemic corticosteroids</div>\n<div>\n within 30 days prior to study entry.</div>\n<div>\n NOTE: Use of systemic or inhaled corticosteroids, such as for acute therapy for</div>\n<div>\n Pneumocystis jiroveci pneumonia (previously called Pneumocystis carinii</div>\n<div>\n pneumonia; PCP) or asthma exacerbation or TB Immune Reconstitution</div>\n<div>\n Inflammatory Syndrome (IRIS), and prednisone ≤10 mg (or equivalent) is</div>\n<div>\n permitted as a stable or tapering dose.</div>\n<div>\n 4.2.12 Active drug or alcohol use or dependence that, in the opinion of the site</div>\n<div>\n investigator, would interfere with adherence to study requirements.</div>\n<div>\n 4.2.13 History of deep venous thrombosis or pulmonary emboli</div>\n
      • primary_end_points<div>\n MPA concentration levels obtained at 2, 4, 6, 8, 10, and 12 weeks after DMPA is</div>\n<div>\n administered. The 12 week measurement will be the measurement obtained</div>\n<div>\n closest to 84 days after DMPA is administered. The allowable window for the</div>\n<div>\n measurement is ±7 days, as stated in section 6.2.3.</div>\n<div>\n Plasma progesterone levels obtained at 2, 4, 6, 8, 10, and 12 weeks after DMPA</div>\n<div>\n is administered.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Dr. David Schnabel MPH</p>\n<p>\n Dr. Eunice Akinyi Ouma MD</p>\n<p>\n Dr. kevin P. Cain MD</p>\n<p>\n Mr. Francis Mbata Angira </p>\n
      • other_details_explanation<p>\n Phase 1 was done in the sponsor's country.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU - 25th April 2016</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • 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 CRS
      • single_site_physical_addressJOOTRH GROUNDS , CLINICAL RESEARCH CENTRE
      • single_site_contact_personDR. DAVID SCHNABEL
      • single_site_telephone+254703485481
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4 Sites
      • number_of_sites
      • multi_country_listSouth Africa - Durban CRS, Parirenyatwa, University of Wittswatersrand\nGaborone - Botswana CRS
      • data_monitoring_committeeYes
      • total_enrolment_per_site10 participants
      • total_participants_worldwide46 participants
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • 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_nameDavid
      • investigator1_middle_name
      • investigator1_family_nameSchnabel
      • investigator1_qualificationMPH
      • investigator1_professional_addressKisumu CRS, JOOTRH Grounds, Box 1578, Kisumu 40100
      • investigator1_telephone+254703485481
      • investigator1_emaildschnabel@cdc.gov
      • organisations_transferred_No
      • number_participants10 participants
      • notification<p>\n we have requested for an expedited review. Attached evidence of payment of 2000 USD</p>\n
      • approval_date28-07-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-05-2016
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This was a 12-week, phase II, open-label, single-arm, study of steady-state PK interactions among women coinfected with HIV and TB receiving EFV-based cART and RIF-based anti-TB Treatment. Among 42 PK-evaluable women from Kenya (10) South Africa (20), Botswana (6) and Zimbabwe (6) , median age was 32 years and median CD4 was 414 cells/mm3. Five women (11.9%; 95% CI, 4.0–25.6%) had MPA <0.1 ng/mL at week 12; of these, one had MPA <0.1 ng/mL at week 10. The median clearance of MPA was 19 681 L/week compared with 12 118 L/week for historical controls. There were no adverse events related to DMPA, and progesterone concentrations were <1 ng/mL for all women for the study duration. DMPA, when given with rifampicin and efavirenz, was safe. MPA clearance was higher than in women with HIV not on ART, leading to subtherapeutic concentrations of MPA in 12% of women, suggesting that more frequent dosing might be needed.</p>\n
      • implication_results<p>\n Since Depot Medroxyprogesterone (DMPA) clearance was higher in women on concurrent Rifampicin and Efavirenz treatment than in women with HIV and not on ART, more frequent DMPA dosing might be needed to prevent unintended pregnancies which studies have associated with increased perinatal morbidity and mortality. There is however need to conduct Phase 3 trials to see if these findings are consistent and replicable</p>\n
      • quantity_importedPlease check A5338 Drug AC
      • quantity_dispensedPlease check A5338 Drug AC
      • quantity_destroyedPlease check A5338 Drug AC
      • quantity_exportedPlease check A5338 Drug AC
      • balance_site0
      • final_date0000-00-00
      • modified2020-09-22 08:28:46
      • created2016-05-09 09:58:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id327
        • application_id495
        • given_nameDavid
        • middle_name
        • family_nameSchnabel
        • qualificationMPH
        • professional_addressKisumu CRS , JOOTRH Grounds, Box 1578, Kisumu 40100
        • telephone+254703485481
        • emaildschnabel@cdc.gov
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
    • SiteDetail(array)
      • 0(array)
        • id390
        • application_id495
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id259
        • application_id495
        • sponsorThe National Institute of Allergy and Infectious Diseases
        • sponsor_type(null)
        • contact_person
        • addressDrban 4001
        • telephone_number27315663933
        • fax_number
        • cell_number27315663933
        • email_addressmnggibisa@ecarefoundation.com
        • created2016-05-09 10:10:16
        • modified2016-05-10 10:39:56
  • 3(array)
    • Application(array)
      • id844
      • user_id577
      • trial_status_id6
      • abstract_of_study<div>\n Introduction:</div>\n<div>\n Dominated by depression, mental disorders are a leading cause of global disability. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy studies showing that local non-specialists can provide evidence-based care for depression in LMICs, few studies have advanced to implementation research. As emphasized by a recent World Health Organization (WHO) initiative, integration of depression treatment into existing systems of care is critical to achieving public health impact. Kenyan leaders recently launched an initiative to scale-up treatment for mental disorders in primary healthcare, prioritizing depression. Yet, they lack an evidence base for the two essential treatments – psychotherapy and second-generation antidepressants - without which the scale-up will fall short of its potential. The proposed research responds to this need and builds on our current work in Kisumu, showing that Interpersonal Psychotherapy (IPT) can be delivered by trained non-specialists with high efficacy for the treatment of depression and/or PTSD using fluoxetine or Interpersonal therapy. Additionally, the study applies a SMART design to manage non-responsiveness to the given treatment by switching or combination.</div>\n<div>\n Objectives: We propose to partner with local and national mental health stakeholders in Kenya to evaluate: (1) non-specialist delivery of evidence-based depression and/or PTSD treatment integrated within existing healthcare centers in regard to clinical effectiveness and implementation parameters; including (2) costs and cost-benefit ratios for depression and/or PTSD care. Given that evidence-based psychotherapy and second-generation antidepressants are the two leading first-line treatments for depression and/or PTSD and are feasible to deliver in Kenya, our goal is to test an implementation strategy for improving equitable access to these treatments by integrating them with primary care.</div>\n<div>\n Methodology:</div>\n<div>\n Given the novelty of non-specialist depression care and primary care integration for Kenya, we will use an effectiveness-implementation hybrid design type I, which emphasizes effectiveness outcomes for the new setting and study population, while also gathering implementation data for future scale up. In collaboration with the 80-member FACES team currently providing integrated HIV care to Kisumu County Hospital (KCH) primary care outpatient clinics (~10,000 patients/month), we will randomize 2000 adult KCH primary care patients with Major Depressive Disorder (MDD) to receive IPT delivered by non-specialists trained in the study or fluoxetine delivered by fluoxetine trained providers in the study and follow them for 30 months. We will use the Exploration, Preparation, Implementation and Sustainment (EPIS) framework to inform the research and incorporate positive findings into practice. Given the high prevalence of MDD-PTSD co- morbidity, we will leverage the U01 to support a Sequential, Multiple Assignment Randomized Trial (SMART) by recruiting an additional 710 participants with MDD and/or PTSD (irrespective of HIV status) for a total of 2710 participants. Local non-specialists will be trained in mental health care for the SMART and hired</div>\n<div>\n August 22, 2019 iv Version 1.9</div>\n<div>\n through the Kenyan Ministry of Health to work at KCH. After the study, Kisumu County will continue their payroll and the fluoxetine supply.</div>\n<div>\n Data analysis: the study will compare short and long term (relapse) outcomes for IPT versus fluoxetine treatment (Aim 1), and calculate costs and cost-benefit ratios for each treatment arm (Aim 2).</div>\n<div>\n Results:</div>\n<div>\n The results of the proposed research will (1) produce a scalable strategy for delivering depression treatments in sub-Saharan Africa using non-specialists integrated within existing primary care structures and (2) offer policy makers short and long-term cost-benefit options for integrated depression care with corresponding effectiveness and implementation values.</div>\n
      • study_title<div>\n A SEQUENTIAL, MULTIPLE ASSIGNMENT RANDOMIZED TRIAL (SMART) FOR NON-SPECIALIST TREATMENT OF COMMON MENTAL DISORDERS IN KENYA: LEVERAGING THE DEPRESSION AND PRIMARY-CARE PARTNERSHIP FOR EFFECTIVENESS-IMPLEMENTATION RESEARCH (DAPPER) PROJECT (SMART-DAPPER)</div>\n<div>\n  </div>\n<div>\n  </div>\n
      • laymans_summary<p>\n Global standard, evidence-based care for major depression and PTSD, fluoxetine and Interpersonal Psychotherapy (IPT), can be effectively delivered by non-specialists. 73-79% of participants experienced complete remission from depression and PTSD after 1st line treatment.   For those who achieved remission after 1st line treatment, only 4-5% have depression or PTSD 9-12m after treatment ended. Non-specialist treatment is low cost and linked to strong economic gains, which may offset costs. </p>\n
      • short_titleLEVERAGING THE DEPRESSION AND PRIMARY-CARE PARTNERSHIP FOR EFFECTIVENESS-IMPLEMENTATION RESEARCH
      • protocol_noECCT/20/01/01
      • version_noVersion 2.0
      • date_of_protocol08-08-2019
      • study_drugDeprozet
      • disease_conditionDepression and Post Traumatic Stress Disorder (PTSD)
      • 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_nameFluoxetine
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresslinongeri@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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert0
      • applicant_pictorial_sample1
      • applicant_gcp_training0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Linnet Ongeri
      • declaration_date107-01-2020
      • declaration_principal_investigatorMuthoni Mathai
      • declaration_date207-01-2020
      • placebo_presentNo
      • study_objectives<p>\n Aim 1: Determine the effectiveness of non-specialist-delivered Interpersonal Psychotherapy(IPT), fluoxetine, or combination for MDD and PTSD. </p>\n<p>\n Aim 2: Investigate key presumed mediators of the relationship between treatment and remission  </p>\n<p>\n Aim 3: Identify demographic and clinical moderators of the relationship between treatment and remission.  </p>\n<p>\n  Aim 4. Estimate the costs and cost-benefit ratios for fluoxetine and IPT treatment of depression and PTSD.</p>\n
      • principal_inclusion_criteria<div>\n (1) KCH adult primary care outpatient clinic attendees who screen positive for MDD on the MINI;</div>\n<div>\n (2) KCH adult primary care outpatient clinic attendees who screen positive for PTSD on the PCL</div>\n<div>\n (3) Ability to attend weekly IPT sessions/fluoxetine monitoring;</div>\n<div>\n (4) 18 years or older.</div>\n
      • principal_exclusion_criteria<div>\n (1) Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation);</div>\n<div>\n (2) Acute suicidality (moderate or high score on the MINI suicidality module) requiring higher level of care;</div>\n<div>\n (3) drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher or DAST score of 3 or higher);</div>\n<div>\n (4) History of mania or requiring treatment for bipolar affective disorder hypomania (positive score on MINI mania/hypomania module);</div>\n<div>\n (5) Outside mental health treatment during the SMART-DAPPER treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team). Participants will be asked to not start new mental health treatment during the SMART-DAPPER treatments, but will be assured that this is not prohibited. Participants who do will be treated as dropouts.</div>\n<div>\n (6) Pregnant or breastfeeding</div>\n
      • primary_end_points<p>\n <span class=\"term\" data-term=\"primary outcome measure\" display:=\"\" font-size:=\"\" helvetica=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; background-position: left bottom; background-size: 4px 1px; background-repeat: repeat-x; transition: background-color 0s ease 0s, all 0.2s ease 0s, box-shadow 0s ease 0s, all 0.2s ease 0s, color 0s ease 0s, all 0.2s ease 0s; border-bottom: 1px dotted; color: rgb(17, 46, 81); cursor: pointer; font-family: \" tabindex=\"0\" title=\"Show definition\">Primary Outcome Measures </span><span font-size:=\"\" helvetica=\"\" sans=\"\" source=\"\" style=\"font-family: \"> :</span></p>\n<ol font-size:=\"\" helvetica=\"\" margin-bottom:=\"\" margin-top:=\"\" sans=\"\" source=\"\" style=\"box-sizing: border-box; font-family: \">\n <li style=\"box-sizing: border-box; font-size: 15px; line-height: 1.6; margin-top: 0.7ex;\">\n Change in the Mini International Psychiatric Interview (MINI) depression module [ Time Frame: baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months ]\n <div class=\"tr-indent2\" style=\"box-sizing: border-box; line-height: 1.6; clear: both; margin-left: 1em; margin-top: 1ex;\">\n Change in the diagnostic measure of major depressive disorder</div>\n </li>\n <li style=\"box-sizing: border-box; font-size: 15px; line-height: 1.6; margin-top: 0.7ex;\">\n Change in the Mini International Psychiatric Interview (MINI) PTSD module [ Time Frame: baseline, 1.5, 3, 6, 9, 12, 18, 24 and 30 months ]\n <div class=\"tr-indent2\" style=\"box-sizing: border-box; line-height: 1.6; clear: both; margin-left: 1em; margin-top: 1ex;\">\n Change in the diagnostic measure of PTSD</div>\n </li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifySMART-DAPPER is an implementation study of how to integrate proven treatments for depression and trauma-related disorders into public sector primary care at Kisumu County Hospital (KCH). The treatments (interpersonal Psychotherapy [IPT]) and Fluoxetine), as well as the indications for which they will be used, and their delivery modality, have all been thoroughly empirically validated.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifySMART-DAPPER is an implementation study of how to integrate proven treatments for depression and trauma-related disorders into public sector primary care at Kisumu County Hospital (KCH). The treatments (interpersonal Psychotherapy [IPT]) and Fluoxetine), as well as the indications for which they will be used, and their delivery modality, have all been thoroughly empirically validated.
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The SMART DAPPER study core team consists of 5 psychiatrist who provide supervision to both the fluoxetine team providers and study therapists. Supervision is done through weekly calls to each member of the study team during this inital stage of practice and weekly online call meetings with the core team. The core team on the ground in Kisumu consists of 1 study pharmacist, 2 study cordinators, 1 lead nurse, 2 lead therapists, a lead clinical evaluator and a tracker. Diagnosis is done using a standardized diagnostic tool called the MINI(tool designed to be used by lay trained personnel) by trained clinical evaluators who are 16 in number. The fluoxetine arm is  undertaken by a team of 6 fluoxetine nurses and clinical officers. The IPT arm is undertaken by a team of 27 trained lay therapists.</p>\n<p>\n This is an implementation type of trial and hence our study will be supported by a number of KCH staff. KCH has 2 CO psychiatrists who form a part of our study team (fluoxetine providers), the lead pharmacist also works in the facility. All study staff have been trained in GCP and study SOPs. The hospital being a county hospital has all critical staff including specialist doctors (surgeon, physician, paeditrician, psychiatrist). The hospital has a theatre facilities for emergency care. Kisumu county hospital is the only hospital in Kisumu with an in patient admission facility for mental illness care. </p>\n
      • other_details_explanation<p>\n Trail is being conducted in the host country of the applicant</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n UCSF ethical continuing approval committee 04/05/2019</p>\n<p>\n Kenyatta National Hospital continuing ethical approval commitee 20th July 2019</p>\n<p>\n 1 site</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorActive Comparator: Interp
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKisumu County Hospital
      • single_site_physical_addressKisumu City
      • single_site_contact_personDr. Dickens Onyango
      • single_site_telephone+254726797844
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site2710
      • total_participants_worldwide2710
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • 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_nameLinnet
      • investigator1_middle_name
      • investigator1_family_nameOngeri
      • investigator1_qualificationPsychiatrist
      • investigator1_professional_addressP.O Box 5840-00200
      • investigator1_telephone+254722615999
      • investigator1_emaillinongeri@gmail.com
      • organisations_transferred_Yes
      • number_participants2710
      • notification
      • approval_date31-03-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonProtocol
      • final_report<div>\n Mental conditions are a leading cause of global disability. The World Health Organization identifies psychosocial and psychopharmacological treatments as essential to mental health care. The SMART DAPPER study used a sequential-multiple-assignment-randomized trial with 1:1 randomization to Interpersonal Psychotherapy (IPT) or fluoxetine to evaluate the effectiveness of these interventions delivered by non-specialists to treat major depression and posttraumatic stress disorder (PTSD). Participants not in remission at the end of first-line treatment were randomized to switch or combination treatment.  Participants were public sector primary care patients in Kisumu who provided informed consent, aged 18 or older, and had major depression and/or PTSD. IPT is an evidence-based treatment for depression and PTSD, which improves symptoms by addressing problems in social relationships. Fluoxetine is a Selective Serotonin Reuptake Inhibitor on the Kenyan essential drugs list. Medication for the study was obtained through KEMSA.  </div>\n<div>\n  </div>\n<div>\n The primary outcome was remission of depression and PTSD at the end of the first-line treatment, assessed by thresholds on the Beck-Depression-Index-2 and PTSD-Checklist-5. Participants were randomly assigned to IPT (1082) or fluoxetine (1079). At treatment end, 12.9% of IPT (127 of 986) and 10.0% of fluoxetine (88 of 877) met threshold score for major depression—odds ratios (ORs) 0.024 (IPT), 0.017 (fluoxetine), no significant group difference. At the end of treatment, 17.5% of IPT (173 of 986) and 12.2% of fluoxetine (107 of 877) met the threshold score for PTSD—ORs 0.028 (IPT), 0.018 (fluoxetine), favoring fluoxetine (ratio of ORs 0.645, p=0.015).  For those who achieved remission after 1st line treatment, only 4-5% have major depression or PTSD 9-12m after treatment ended.  </div>\n<div>\n  </div>\n<div>\n There were also statistically significant gains in economic productivity from baseline to the end of first-line treatment. The percentage of participants earning a monthly income rose from 54.9% at baseline to 59.8% after treatment in the IPT group, and from 54.5% to 61.5% in the FLX group. Average monthly income among earners increased by KES 1920 with IPT and KES 1350 with FLX. Both treatments lowered absenteeism, with reductions of 1.5 and 1.9 days per month in the IPT and FLX arms, respectively. FLX was significantly more effective in reducing presenteeism, with a decrease of 4.8 days of partial inability to work per month, compared to a 3.3 day reduction in the IPT group (p=0.006).</div>\n<div>\n  </div>\n
      • implication_results<p>\n Mental health services, adherent to global standards, can be successfully implemented at a large scale in low-resource settings. Non-specialist delivery of Interpersonal Psychotherapy (IPT) and fluoxetine integrated with primary care is highly effective for remission of major depression and PTSD and may lead to significant gains in economic productivity</p>\n
      • quantity_imported0
      • quantity_dispensed131,685
      • quantity_destroyed0
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2024-10-02 15:38:27
      • created2020-01-07 09:39:23
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id522
        • application_id844
        • given_nameAnne
        • middle_nameMuthoni
        • family_nameMathai
        • qualificationPsychiatrist
        • professional_addressP.O.Box 30197, GPO, Nairobi, Kenya
        • telephone0722329904
        • emailmuthonimathai@gmail.com
        • created2020-01-07 09:45:39
        • modified2020-03-18 19:27:54
      • 1(array)
        • id523
        • application_id844
        • given_nameSusan
        • middle_name
        • family_nameMeffert
        • qualificationPsychiatrist
        • professional_addressUCSF
        • telephone+4155151290
        • emailSusan.Meffert@ucsf.edu
        • created2020-01-07 09:50:37
        • modified2020-03-18 19:27:54
    • SiteDetail(array)
      • 0(array)
        • id694
        • application_id844
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        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-01-07 09:45:39
        • modified2020-03-18 19:27:54
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id410
        • application_id844
        • sponsorNIMH
        • sponsor_typeResearch Institution
        • contact_personAndrea Horvathmarques
        • addressBethesda, Maryland
        • telephone_number301-443-3945
        • fax_number
        • cell_number301-443-3945
        • email_addressandrea.horvathmarques@nih.gov
        • created2020-01-07 09:45:39
        • modified2020-03-18 19:27:54
  • 4(array)
    • Application(array)
      • id1148
      • user_id659
      • trial_status_id1
      • abstract_of_study<div>\n Study CKJX839B12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1,</div>\n<div>\n Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD</div>\n<div>\n (atherosclerotic cardiovascular disease)will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of</div>\n<div>\n CV death, non-fatal MI and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.</div>\n<div>\n This is a multi-center, multi-country and event-driven study. Approximately 15,000 participants meeting the eligibility criteria will be randomized. Since 50%</div>\n<div>\n screening failure rate is expected, approximately 30,000 participants are expected to be screened. Participants eligible for this trial will include male and female</div>\n<div>\n participants age 40 years and older who (a) have established ASCVD, and, (b) an LDL-C 1≥.8 mmol/L (70 mg/dL) despite the use of high-intensity statin</div>\n<div>\n therapy.</div>\n
      • study_title<div>\n A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with</div>\n<div>\n established cardiovascular disease</div>\n
      • laymans_summary<div>\n A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular</div>\n<div>\n disease.</div>\n
      • short_titleVICTORION-2 PREVENT
      • protocol_noECCT/22/05/01
      • version_noCKJX839B12302 Protocol Version 00
      • date_of_protocol08-07-2021
      • study_drugInclisiran
      • disease_conditionAtherosclerotic cardiovascular disease (ASCVD)
      • 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_nameInclisiran
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameNot applicable
      • comparator_registeredNot applicable
      • comparator_countriesNot applicable
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressraps.clinicaltrials@novartis.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd0
      • 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_applicantSarah Muthuri
      • declaration_date119-05-2022
      • declaration_principal_investigatorDr. Anthony Gikonyo
      • declaration_date219-05-2022
      • placebo_presentYes
      • study_objectives<div>\n <strong>Primary objective:</strong></div>\n<div>\n Inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal</div>\n<div>\n ischemic stroke) in participants with established ASCVD and a LDL-C ≥1.8 mmol/L (70 mg/dL)</div>\n<div>\n <strong>Secondary objective(s)</strong></div>\n<div>\n Inclisiran compared to placebo in reducing the risk of CV death.</div>\n<div>\n Inclisiran compared to placebo in reducing the risk of 4P-MAC (composite of CV death, non-fatal MI, non-fatal ischemic</div>\n<div>\n stroke and urgent coronary revascularization).</div>\n<div>\n Inclisiran compared to placebo in reducing the risk of all-cause death.</div>\n
      • principal_inclusion_criteria<div>\n Patients eligible for inclusion in this study must meet all of the following criteria:</div>\n<div>\n - Male or female ≥40 years of age</div>\n<div>\n - Fasting LDL-C ≥1.8 mmol/L (70 mg/dL) at the Screening Visit</div>\n<div>\n - At the Screening Visit, participants must be on a stable (≥4 weeks) and</div>\n<div>\n well-tolerated lipid-lowering regimen (including e.g. with or without</div>\n<div>\n Ezetimibe) that must include a high-intensity statin therapy with either</div>\n<div>\n atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD</div>\n<div>\n - Established CV disease, defined as any of the following:</div>\n<div>\n - Previous myocardial infarction</div>\n<div>\n - Previous ischemic stroke</div>\n<div>\n - Symptomatic peripheral arterial disease (PAD), as evidenced by either</div>\n<div>\n intermittent claudication with ABI <0.85, prior peripheral arterial</div>\n<div>\n revascularization procedure, or, amputation due to atherosclerotic</div>\n<div>\n disease</div>\n<div>\n Other inclusion criteria are listed in the clinical study protocol.</div>\n
      • principal_exclusion_criteria<div>\n <strong>Patients meeting any of the following criteria are not eligible for inclusion in this study.</strong></div>\n<div>\n - New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if</div>\n<div>\n applicable), Screening Visit, or at the Baseline Visit (Day1)</div>\n<div>\n - Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or</div>\n<div>\n marketed drug within 2 years prior to the first study visit</div>\n<div>\n - Pregnant or nursing (lactating) women</div>\n<div>\n - Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study</div>\n<div>\n treatment</div>\n<div>\n Other exclusion criteria are listed in the clinical study protocol.</div>\n
      • primary_end_points<p>\n Time to the first occurrence of 3P-MACE</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Site 1200: THE KAREN HOSPITAL LTD</div>\n<div>\n Address: The Karen Hospital Langata Road, Karen, Nairobi P.O. BOX 74240-00200</div>\n<div>\n  </div>\n<div>\n <div>\n The Karen Hospital is designed for care and treatment of cardiology patients and has a full clinical laboratory capability. The Hospital also has a dental unit.</div>\n <div>\n The hospital is staffed by 4 Cardiologists, 4 physicians, 10 medical officers, 10 clinical officer, 1 dental surgeons, 2 psychologists,1 pharmacist, 2 visiting</div>\n <div>\n psychiatrist, 10 physician assistant, 96 nurses and 10 laboratory technologists. The facility supports healthcare to the general public and has satellite units</div>\n <div>\n serving a wide population in Nairobi and adjacent counties. This is enough to meet recruitment requirements.</div>\n <div>\n The site has a waste disposal policy and this in in line with the regulatory requirements of the hospital. The waste is disposed by a third-party entity, with</div>\n <div>\n whom we have a written contract in place. There is also a quality assurance policy which is implemented at the hospital according to ISO standards.</div>\n <div>\n  </div>\n <div>\n <p>\n <strong><u>Site 1202: Strathmore University Medical Centre (SUMC) </u></strong></p>\n <p>\n The SUMC is designed for clinical trials and has a full clinical laboratory with bioanalytical capability. The Centre is managed by Strathmore University and the CREATES consortium. The Centre also has a dental unit. The medical centre is staffed by 2 pediatricians, 2 physicians, 1 medical officer, 1 clinical officer, 4 dental surgeons, 3 psychologists, 1 pharmacist, 1 visiting psychiatrist, 1 physician assistant, 4 nurses and 4 laboratory technologists. The facility supports healthcare to university students and staff and also general public.</p>\n <p>\n <strong><u>Location:</u></strong></p>\n <p>\n The cardiovascular study will be conducted at SUMC; recruitment will occur at the clinic. SUMC is located at Strathmore University in Madaraka Estate of Nairobi west, Nairobi County.</p>\n <p>\n SUMC will be staffed by qualified research personnel from KEMRI, UoN and SUMC. The site has a pharmacy, treatment area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done.</p>\n <p>\n <strong><u>Provision of medical care </u></strong></p>\n <p>\n SUMC is an outpatient facility with a 2-bed holding unit and a separate emergency resuscitation area. The center serves as a clinical trials facility for both pediatric and adult studies. The participants who will require inpatient care will be admitted to Coptic Hospital Ngong Road or Nairobi South Hospital as SUMC already has an existing working arrangement</p>\n <p>\n  </p>\n </div>\n <div>\n <p>\n The patients will be recruited from the SUMC database and referral from other health facilities and other medical practitioners. SUMC currently runs a diabetic clinic and follows a cohort of more than 300 patients. The Clinical also runs Sickle cell clinic as one of the NCDs programs.</p>\n </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The Sponsor has decided that Switzerland (the host country of the Sponsor) will not be conducting this study due to low recruitment potential.</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n country</td>\n <td>\n agency</td>\n <td>\n application date</td>\n </tr>\n <tr>\n <td>\n Norway</td>\n <td>\n <div>\n Norwegian Medicines AgencyGrensesvingen 26,</div>\n <div>\n 0663 Oslo</div>\n </td>\n <td>\n 24-Feb-2022</td>\n </tr>\n <tr>\n <td>\n Poland</td>\n <td>\n <div>\n Departament BadaÅ„ Klinicznych Produktów</div>\n <div>\n Leczniczych, UrzÄ…d</div>\n <div>\n Rejestracji Produktów Leczniczych, Wyrobów</div>\n <div>\n Medycznych i Produktów Biobójczych,</div>\n <div>\n Al.Jerozolimskie 181C, 02-222 Warsaw</div>\n </td>\n <td>\n 02-Feb-2022</td>\n </tr>\n <tr>\n <td>\n Romania</td>\n <td>\n <div>\n National Agency for Medicines and Medical</div>\n <div>\n Devices, Str. Aviator Sanatescu 48, Sector 1,</div>\n <div>\n Bucharest, 011478, Romania</div>\n </td>\n <td>\n 28-Oct-2021</td>\n </tr>\n <tr>\n <td>\n Slovenia</td>\n <td>\n <div>\n Agency for Medicinal Products and</div>\n <div>\n Medical Devices of the Republic of</div>\n <div>\n Slovenia</div>\n <div>\n Slovenčeva ulica 22, 1000 Ljubljana</div>\n </td>\n <td>\n 22-Dec-2021</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <tbody>\n <tr>\n <td>\n Country</td>\n <td>\n Agency</td>\n <td>\n Decision date</td>\n <td>\n Number of sites</td>\n </tr>\n <tr>\n <td>\n Austria</td>\n <td>\n <div>\n Bundesamt für Sicherheit im Gesundheitswesen (BASG), Österreichische Agentur für</div>\n <div>\n Gesundheit und Ernährungssicherheit (AGES), Institut Überwachung (INS),</div>\n <div>\n Abteilung Klinische Prüfung (CLTR) ", Traisengasse 5, 1200 Wien</div>\n </td>\n <td>\n 30-Nov-2021</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Belgium</td>\n <td>\n <div>\n Agence Fédérale des Médicaments et Produits de Santé, Département Recherche</div>\n <div>\n et Développement, Eurostation II, Avenue Galilée 5/03, 1210 Brussels</div>\n </td>\n <td>\n 02-Feb-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Bulgaria</td>\n <td>\n Bulgarian Drug Agency, 8 Damyan Gruev Str., Sofia, 1303</td>\n <td>\n 10-Mar-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Croatia</td>\n <td>\n Ministarstvo zdravlja, Ksaver 200a, 10 000 Zagreb, Hrvatska</td>\n <td>\n 20-Jan-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Czech Republic</td>\n <td>\n State Institute for Drug Control Šrobárova 48, 100 41, Prague 10</td>\n <td>\n 10-Mar-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Denmark</td>\n <td>\n Danish Health and Medicines Authority Axel Heides Gade 1, 2300 Copenhagen S</td>\n <td>\n 18-Jan-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Estonia</td>\n <td>\n State Agency of Medicines, Nooruse 1, 50411 Tartu</td>\n <td>\n 09-Dec-2021</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Finland</td>\n <td>\n <div>\n Finnish Medicines Agency, Mannerheimintie 103b, P.O BOX 55, FI-00034</div>\n <div>\n Helsinki</div>\n </td>\n <td>\n 21-Mar-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n France</td>\n <td>\n <div>\n Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), 143/147,</div>\n <div>\n boulevard Anatole France, 93285 SAINT-DENIS CEDEX</div>\n </td>\n <td>\n 15-Nov-2021</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Hungary</td>\n <td>\n National Institute of Pharmacy and Nutrition, 1051 Budapest, V. Zrínyi u. 3.</td>\n <td>\n 18-Jan-2022</td>\n <td>\n  </td>\n </tr>\n <tr>\n <td>\n Italy A </td>\n <td>\n genzia Italiana del Farmaco (AIFA), Via del Tritone, 181, 00187 Roma</td>\n <td>\n 03-Dec-2021</td>\n <td>\n  </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<div>\n Germany / Rejection date: 14-Dec-2021</div>\n<div>\n The Victorion-2 Prevent study has been approved by 12 Health Authorities to date, (including the US, Canada, France, Spain, Italy, Estonia, Lithuania, Slovakia, China and India); however, the</div>\n<div>\n application was rejected by the German Health Authority (BfArM)</div>\n
      • other_details_regulatory_halted<p>\n Not applicable to date. Should the study be halted in any country during the conduct or the review process, the MoH will be informed accordingly</p>\n
      • estimated_durationApprox. 18 - 19 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNot applicable
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states47
      • number_of_sites2
      • multi_country_list1. Argentina 2. Australia; 3. Austria; 4. Belgium; 5. Bosnia and Herzegovina; 6. Brazil; 7. Bulgaria; 7. Canada; 8. Chile; 9.\nChina; 10. Colombia; 11. Croatia; 12. Czechia; 13. Denmark; 14. Estonia; 15. France; 16. Georgia; 17. Germany; 18.\nHungary; 19. India; 20. Israel; 21. Italy; 22. Japan; 23. Kenya; 24. Republic of Korea; 25. Latvia; 26. Lithuania; 27.\nMalaysia; 28. Mauritius; 29. Mexico 30. Netherlands; 31. New Zealand; 32. Philippines; 33. Poland; 34. Portugal; 35.\nRomania; 36. Russian Federation; 37. Singapore; 38. Slovakia; 39. Slovenia; 40. South Africa; 41. Spain; 42. Sweden; 43.\nTaiwan; 44. Thailand; 45. Turkey; 46. United Kingdom; 47. USA
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive Recruitment\n15 Participants per site\n
      • total_participants_worldwideApproximately Fifteen Thousand(15000) participants will join the study worldwide.
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameAnthony
      • investigator1_middle_name
      • investigator1_family_nameGikonyo
      • investigator1_qualificationMedical Doctor- Cardiologist
      • investigator1_professional_addressThe Karen Hospital Langata Road, Karen, Nairobi
      • investigator1_telephone+254700535280
      • investigator1_emailanthony.gikonyo@karenhospital.org
      • organisations_transferred_No
      • number_participantsApproximately thirty (30) participants are expected to join this study in Kenya
      • notification
      • approval_date05-10-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-04-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-17 20:53:59
      • created2022-05-17 11:49:53
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id826
        • application_id1148
        • given_nameAnthony
        • middle_name
        • family_nameGikonyo
        • qualificationMedical Doctor- Cardiologist
        • professional_addressThe Karen Hospital Langata Road, Karen, Nairobi
        • telephone+254700535280
        • emailanthony.gikonyo@karenhospital.org
        • created2022-05-17 12:21:12
        • modified2023-04-04 10:31:10
      • 1(array)
        • id920
        • application_id1148
        • given_nameELIJAH
        • middle_nameSAMMY NYAINDA
        • family_nameOGOLA
        • qualificationMB.ChB, M.Med
        • professional_addressP.O.BOX 19676 - 002020, NAIROBI
        • telephone254 (0) 20 2710062,2726502,2725452
        • emailelijah.ogola@uonbi.ac.ke;onogola@gmail.com
        • created2023-04-03 19:51:22
        • modified2023-04-04 10:31:10
    • SiteDetail(array)
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        • id1283
        • application_id1148
        • county_id47
        • site_nameThe Karen Hospital
        • physical_addressThe Karen Hospital Langata Road, Karen, Nairobi, PO BOX 74240-00200
        • contact_details+254700535280
        • contact_personDr. Anthony Gikonyo
        • site_capacity(null)
        • misc(null)
        • created2022-05-17 12:21:12
        • modified2023-04-04 10:31:10
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          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1469
        • application_id1148
        • county_id47
        • site_nameCentre for research in Therapeutic Sciences (CREATES
        • physical_addressStrathmore University, Madaraka Estate, Ole Sangale Road
        • contact_details254 (0) 20 2710062,2726502,2725452
        • contact_personProf Elijah SN OGOLA
        • site_capacity(null)
        • misc(null)
        • created2023-04-03 20:05:03
        • modified2023-04-04 10:31:10
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id593
        • application_id1148
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personSarah Muthuri
        • addressNVS Kenya Limited 27th Floor, Britam Towers Hospital Road, Upperhill, P.O.Box 46057-00100 GPO, Nairobi, Kenya
        • telephone_number+254 20 245 9112
        • fax_number
        • cell_number+ 254 722706941
        • email_addresssarah.muthuri@novartis.com
        • created2022-05-17 12:21:12
        • modified2023-04-04 10:31:10
• page_options(array)
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  • Application(array)
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  • Permission(empty)
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App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

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