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• applications(array)
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    • Application(array)
      • id1513
      • user_id908
      • trial_status_id1
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multi-centre study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 12. As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited. There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus. The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose.</p>\n<p>\n  </p>\n<p>\n This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated. Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleClearance of High-Risk HPV
      • protocol_noECCT/25/02/07
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • 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_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.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_applicantGerald Carstens
      • declaration_date124-02-2025
      • declaration_principal_investigatorProf. Fredrick Chite Asirwa (NPI), Prof Elizabeth Anne Bukusi (PI)
      • declaration_date224-02-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objectives: </strong></p>\n<p>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives: </strong></p>\n<p>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n<p>\n <strong>Exploratory Objectives: </strong></p>\n<p>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed. </p>\n<p>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed.</p>\n<p>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n 1. Female sex, 25 to 55 years of age (inclusive).</p>\n<p>\n 2. Able and willing to provide informed consent.</p>\n<p>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</p>\n<p>\n a. One hrHPV+ result at least 12 months prior to screening</p>\n<p>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test. </p>\n<p>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible.</p>\n<p>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion.</p>\n<p>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.</p>\n<p>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor.</p>\n<p>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration.</p>\n<p>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed.</p>\n<p>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (e.g., athletes, perimenopause) may also be eligible with the approval of the Medical Monitor.</p>\n<p>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available.</p>\n<p>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit.</p>\n<p>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia.</p>\n<p>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females.</p>\n<p>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin.</p>\n<p>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection.</p>\n<p>\n 5. Have an active pelvic infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).</p>\n<p>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding.</p>\n<p>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1.</p>\n<p>\n 8. Any clinically significant immune suppressing condition.</p>\n<p>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.</p>\n<p>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1.</p>\n<p>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1.</p>\n<p>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).</p>\n<p>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1.</p>\n<p>\n 14. Known to be positive for human immunodeficiency virus.</p>\n<p>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1.</p>\n<p>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed.</p>\n<p>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible.</p>\n<p>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study. </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n For sentinel cohorts:</p>\n<p>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.</p>\n<p>\n  </p>\n<p>\n For fully expanded cohorts, including sentinel:</p>\n<p>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The KEMRI-RCTP facility has:</p>\n<p>\n <strong>1.   Reception and waiting bay:</strong></p>\n<p>\n Provides seating area with good air circulation. Enough seats for 20 participants at a time.</p>\n<p>\n <strong>2.   Six Clinic rooms:</strong></p>\n<p>\n The rooms each have a desk, chairs for participant and staff, an examination coach, examination lamp, BP machine, thermometer, desktop computers, waste bins and sharps container, privacy curtain.</p>\n<p>\n <strong>3.   Pharmacy:</strong></p>\n<p>\n Room has access control and is temperature-controlled with an Air Conditioner maintaining ambient temperature between 15-30°C. It is equipped with a pharmaceutical fridge (2-8°C), two desktop computers, bar code scanners, printer, lockable storage cabinets, ergonomic chairs, thermometers for temperature monitoring.</p>\n<p>\n <strong>4.   Laboratory:</strong></p>\n<p>\n Room is temperature controlled with an Air Conditioner maintaining ambient temperature between 15-30°C. The are temperature monitoring system, 4 printers, 3 desktops, 2 safety cabinets, GeneXpert machine, 2 light microscopes, 2 refrigerated centrifuge, ELISA machine, 2-8°C refrigerator, -20°C freezer, -40°C freezer, five -80°C freezers, Cobas biochemistry machine, Coulter full hemogram machine, incubator.</p>\n<p>\n <strong>5.   Data room:</strong></p>\n<p>\n The room has 10 computers with uninterrupted power supply, printer, label printer, lockable storage cabinets, seats, desk.</p>\n<p>\n <strong>6.   Administration office:</strong></p>\n<p>\n Has desks, desktop computers, seats and lockable storage cabinets.</p>\n<p>\n <strong>7.   Open Office:</strong></p>\n<p>\n Has adequate sitting space that can accommodate 30 Staff.</p>\n<p>\n <strong>8.   Washrooms:</strong></p>\n<p>\n Clean washrooms for both staff and participants.</p>\n<p>\n  </p>\n<p>\n The site also has a backup generator for backup power supply, archival space for storage of archived documents and material., and internet connection.</p>\n<p>\n Emergency facilities: The site has an emergency trolley and portable first aid kit that may be used in the event of an emergency. The facility is also located within a hospital facility that may handle referral cases.</p>\n<p>\n <strong><u>PERSONNEL</u></strong></p>\n<p>\n <strong>Elizabeth Bukusi, MBChB, MMed, MPH, PhD, Principal Investigator</strong></p>\n<p>\n She will provide substantial oversight of all activities that take place at the Kisumu site. As the site Principal Investigator (PI) for the KEMRI team leading activities, she will work closely with the coordinating center and provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, as well as fiscal and administrative management of the study.</p>\n<p>\n <strong>Josephine Odoyo, Internal monitor</strong></p>\n<p>\n Josephine Odoyo is a trained nurse by profession and has wide experience in sexual and reproductive health research having coordinated earlier clinical trials at the Kisumu site. She will be assisting the principal investigators in the planning and implementation stage of the project and offering regulatory services ensuring quality is maintained throughout the study implementation.</p>\n<p>\n <strong>Victor Omollo, MBChB, MPH, Sub-Investigator</strong></p>\n<p>\n Dr. Omollo will take the lead as a sub-investigator with experience having coordinated the POWER open- label PrEP delivery among adolescent girls and young women under RCTP-KEMRI and has been a Co-PI in other studies, including MK-4482-013 study, IMPOWER, and Pharmacy PrEP delivery study. He will assist the primary site coordinator in ensuring the smooth functioning of the research project, coordinating communications with regulatory boards, staff, and investigators, and assisting investigators with implementation, planning, and problem-solving to ensure project goals are met.</p>\n<p>\n <strong>Felix Mogaka, MBChB, MPH, Sub-investigator, primary site coordinator</strong></p>\n<p>\n Dr. Mogaka will be responsible for coordinating the site activities as well as acting as a physician for the study participants, review safety and Adverse event (AE) monitoring, and safety reporting to the study safety monitor, sponsor, and regulatory review bodies. As a coordinator, he will oversee the day-to- day running of the site on behalf of the site PI and supervision of site personnel, development of standard operating procedures including preparation and study results dissemination to the relevant regulatory review boards.</p>\n<p>\n <strong>Greshon Rota, B.Pharm, Pharmacist of Records</strong></p>\n<p>\n The Pharmacist of records will be involved in all matters pertaining to the Pharmacy and Poisons Board (PPB) in regard to the registration of the protocol and act as a link between the Study and PPB. He will assist in dispensing drugs and provide adherence counseling. He will also be responsible for tracking the amount of study drug kits and ensuring documentation of the same.</p>\n<p>\n <strong>Clinical Officer</strong></p>\n<p>\n The clinical officer will assist the study medical officer and physician in performing clinical assessments, carry out medical examinations and prescribe medication as required to the participants. Recognize, monitor, and report study adverse events and help in their management.</p>\n<p>\n <strong>Laboratory Technologist and Manager</strong></p>\n<p>\n The Lab Technologists will be responsible for performing all the lab tests required for the participants, maintaining and charting the temperature logs in the laboratory, preparing samples for archiving and shipment, and ensuring proper storage is done. They will also maintain the Study documents in files and folders appropriately monitor any abnormal results for participants and notify the clinicians appropriately. The Laboratory Manager will be responsible for the overall management of the laboratory, authoring the laboratory SOPs, ensuring that all equipment is serviced and calibrated, and ensuring that all tests are done as per the study protocol.</p>\n<p>\n <strong>Data Manager and data quality assurance officer</strong></p>\n<p>\n The data manager will be responsible for the overall management of the study data ensuring all the needed databases are created and reports generated on a timely basis as needed for each database. Ensuring the confidentiality of participants' data by creating a link log between the participants' study ID and participant's names which will be kept separately under double locked cabinets. The QA officer will be responsible for ensuring quality checks are done on data and all other aspects of the study and will work in collaboration with the coordinator to ensure the study data and processes are of the highest quality. Will also be responsible for entering all the participants data in the appropriate database, and checking data for accuracy, completeness, and consistency. They will also file participant’s binders in an orderly sequence.</p>\n<p>\n <strong>Community Liaison Recruitment and Retention Officer</strong></p>\n<p>\n The Community Liaison Recruitment and Retention Officer will be responsible for planning and mapping out the areas of participant recruitment, overseeing preparing SOPs and acting as a community linkage with the project. He/she will organize the stakeholder meetings and prepare the required IEC materials necessary for the project.</p>\n<p>\n <strong>Front Office Manager</strong></p>\n<p>\n The receptionist will be responsible for receiving the participants, registering their details, and guiding them to the appropriate staff for screening, enrolment, and follow-up visits. He/she will also schedule clinic visit dates for the participants reimburse the participants for their transport and ensure they also receive refreshments. He/she also ensures that there are sufficient screening folders, name charts, medical charts, and CRF files for upcoming screening and enrollment visits.</p>\n<p>\n <strong>HTS Counselor and Mobilizer</strong></p>\n<p>\n The HTS counselors will be responsible for community mobilization, counseling and testing the participants regarding HIV and referring them appropriately. Those who turn positive will be counseled and referred appropriately.</p>\n<p>\n <strong>Drivers</strong></p>\n<p>\n The drivers will assist with all project driving and delivery needs. They will transport staff members to various project activities and assist in the follow-up and recruitment of study participants and locating them where necessary during the accelerated mobilization. They will also be responsible for vehicle maintenance and keeping track of vehicle work tickets/logs.</p>\n<p>\n <strong>Study Administrator</strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the coordinator, PI, and the Chief Finance Administrator and assist in budget preparation, maintaining of proper audit trail for study funds and expenditures, generating monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for handling and accounting for the field advance given to the project.</p>\n<p>\n <strong>Finance Manager</strong></p>\n<p>\n The Finance & Admin Manager is based in Nairobi. She is instrumental in terms of procurement of equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, sub-contracts and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to budgets.</p>\n<p>\n <strong>Human Resource Manager</strong></p>\n<p>\n The Human Resource Manager is responsible for the recruitment of personnel and all staff related issues such as disciplinary, medical insurance, salaries and remuneration among others.</p>\n<p>\n <strong>Office Assistants</strong></p>\n<p>\n The office assistants will be responsible for delivering messages for study needs and ensure that there is a clean environment for participants. They will liaise with the administrator in sending and receiving parcels and courier services. They will also clean the office area, washrooms, and building surrounding, and maintain of study clinic grounds.</p>\n<p>\n <strong>ICT Officer</strong></p>\n<p>\n The ICT officer will be responsible for ensuring that the internet connectivity is of the right quality and speed to enable study activities such as online training, meetings, and data capture to be done with very minimal interruption. He/she will be in charge of network administration of the study.</p>\n<p>\n <strong>PA to the Principal Investigator</strong></p>\n<p>\n The PA to the principal Investigator ensures that the calendar for Prof. Bukusi is updated and that her appointments are scheduled efficiently and convenient for the operations of the project.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable </p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • 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_states4
      • number_of_sites7
      • multi_country_listAustralia \nKenya \nMexico \nNew Zealand \nTurkey
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment. 2-6 participants per site
      • total_participants_worldwide160
      • 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_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_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center, PO Box 088 30100, Nandi Road Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Dear PPB Reviewer,<o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">The application for Prof Elizabeth Anne Bukusi (ECCT/25/02/07) has been re-submitted, including a cover letter and additional documents as requested in the Second Screening Queries. <o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin:0in\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Thank you for your review.<o:p></o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\"><o:p> </o:p></span></p>\n<p style=\"margin: 0in;\">\n <span style=\"font-size: 10pt; font-family: Arial, sans-serif;\">Kind regards<o:p></o:p></span></p>\n<p>\n <span style=\"font-family: Arial, sans-serif; font-size: 10pt;\">Gerald Carstens</span></p>\n
      • approval_date13-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonSatisfactory feedback on review comments
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:27:44
      • created2025-02-07 14:01:00
      • total_sites1
      • ecitizen_invoice354575
    • InvestigatorContact(array)
      • 0(array)
        • id1227
        • application_id1513
        • given_nameElizabeth
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, Cert (Intl Health) PhD, PGD (Ethics), MBE, CIP.
        • professional_addressKEMRI-RCTP, KEMRI CIS Building Lumumba Sub-County Hospital, Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
        • telephone+254 723 686 156
        • emailebukusi@rctp.or.ke
        • created2025-02-07 14:01:00
        • modified2025-02-24 16:25:23
    • SiteDetail(array)
      • 0(array)
        • id1842
        • application_id1513
        • county_id42
        • site_nameKEMRI-RCTP
        • physical_addressKEMRI CIS Building, Lumumba Sub-County Hospital Along Ondiek Highway, P.O Box 614-40100, Kisumu, Kenya
        • contact_details+254 7995 808 08, P.O. Box 614
        • contact_personDr Felix Mogaka
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:25:23
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id807
        • application_id1513
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberNA
        • cell_number+14084016086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:25:23
  • 1(array)
    • Application(array)
      • id1514
      • user_id908
      • trial_status_id1
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n  </p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multi-centre study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n  </p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 12. As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n<p>\n  </p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited. There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus. The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose. This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated.</p>\n<p>\n Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleClearance of High-Risk HPV
      • protocol_noECCT/25/02/06
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • 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_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.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_applicantGerald Carstens
      • declaration_date124-02-2025
      • declaration_principal_investigatorProf. Fredrick Chite Asirwa (NPI); Prof Omu Anzala (PI)
      • declaration_date224-02-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objectives: </strong></p>\n<p>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n<p>\n <strong>Secondary Objectives: </strong></p>\n<p>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n<p>\n <strong>Exploratory Objectives: </strong></p>\n<p>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed. </p>\n<p>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed.</p>\n<p>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</p>\n
      • principal_inclusion_criteria<p>\n 1. Female sex, 25 to 55 years of age (inclusive).</p>\n<p>\n 2. Able and willing to provide informed consent.</p>\n<p>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</p>\n<p>\n a. One hrHPV+ result at least 12 months prior to screening</p>\n<p>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test. </p>\n<p>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible.</p>\n<p>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion.</p>\n<p>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.</p>\n<p>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor.</p>\n<p>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration.</p>\n<p>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed.</p>\n<p>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (e.g., athletes, perimenopause) may also be eligible with the approval of the Medical Monitor.</p>\n<p>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available.</p>\n<p>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit.</p>\n<p>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1.</p>\n
      • principal_exclusion_criteria<p>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia.</p>\n<p>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females.</p>\n<p>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin.</p>\n<p>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection.</p>\n<p>\n 5. Have an active pelvic infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).</p>\n<p>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding.</p>\n<p>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1.</p>\n<p>\n 8. Any clinically significant immune suppressing condition.</p>\n<p>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.</p>\n<p>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1.</p>\n<p>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1.</p>\n<p>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).</p>\n<p>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1.</p>\n<p>\n 14. Known to be positive for human immunodeficiency virus.</p>\n<p>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1.</p>\n<p>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed.</p>\n<p>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible.</p>\n<p>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study. </p>\n
      • primary_end_points<p>\n For sentinel cohorts:</p>\n<p>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.</p>\n<p>\n  </p>\n<p>\n For fully expanded cohorts, including sentinel:</p>\n<p>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Research Clinic</strong></p>\n<p>\n The KAVI-ICR Kenyatta National Hospital (KNH) Research Clinic is located within the premises of the College of Health Sciences, University of Nairobi. The Institute is made up of 3 wings. One wing exclusively hosts the KAVI-ICR Research Laboratory which comprises of 5 laboratories (Safety, PBMC, Tissue Culture, Molecular and Pathogen Sequencing Labs). The floor also hosts our biorepositories that we use to freeze our samples, lab staff offices as well as the institution’s main back up UPS. The second wing hosts administrative, finance, Information Technology (IT), research offices as well as the mucosal lab. This same wing also hosts the investigational product pharmacy. The third wing primarily host the research clinic comprising of a reception/waiting area, 3 counseling rooms, 3 clinic rooms, 1 procedure room, a fully equipped emergency room, research offices, a data room and secure filing room. The second and the third wing also have conference rooms capable of sitting between 20 – 40 people as well as facilitating teleconference meetings. The pharmacy, laboratory and data rooms and offices have secure restricted access doors.</p>\n<p>\n Routine medical care for trial participants is provided on-site at the clinic, including general medical care, medication dispensing, HIV counselling and testing, family planning counselling, and provision of HIV post-exposure prophylaxis. The emergency room has resuscitation equipment including a cardiac defibrillator, oxygen cylinders, and emergency drugs in the event of anaphylaxis. Our procedure room is equipped for protocol specific requirements such administration of investigational product and venous blood sample collection.</p>\n<p>\n The nearby Kenyatta National Hospital is the main referral facility for non-study related health care and has capacity to provide:</p>\n<ol>\n <li>\n Treatment of cervical lesions by cryotherapy or by loop electrosurgical excision procedure (LEEP) at the Cervical Cancer Screening Clinic</li>\n <li>\n Treatment and follow-up of cervical cancer at the Gynecology Outpatient Clinic</li>\n <li>\n HIV care and treatment at the Comprehensive Care Clinic</li>\n <li>\n Outpatient and inpatient care for most medical conditions including COVID-19 disease</li>\n <li>\n Inpatient care for most surgical conditions</li>\n</ol>\n<p>\n In case of medical emergencies at the research clinic, participants will be evacuated by ambulance service to Coptic Hospital for inpatient care including Intensive Care Unit admission if necessary.</p>\n<p>\n KAVI-ICR has also identified community-based organizations that offer support for drug and alcohol addictions as well as victims of gender-based violence.</p>\n<p>\n <strong>Personnel</strong></p>\n<p>\n The site has adequate staff with vast experience in conducting clinical trials. In addition to the principal and sub-investigators, the site has the following staff who will be involved directly in conducting the trial:</p>\n<ol>\n <li>\n Clinical Officers – 4</li>\n <li>\n Nurse Counselors – 4</li>\n <li>\n Community Liaison Officers – 3</li>\n <li>\n Pharmaceutical Technologists – 2</li>\n <li>\n Laboratory Staff - 5</li>\n <li>\n IT Manager – 1</li>\n <li>\n Data Clerks – 2</li>\n</ol>\n<p>\n All research staff are trained in Good Clinical Practice (GCP) and Protection of Human Subjects Research (HSP) at minimum. All staff undergo periodic Standard Operating Procedures (SOP) training as well as Study Specific Procedures (SSP) training prior to the beginning of the trial and as frequently as is required thereafter.</p>\n<p>\n <strong>Pharmacy</strong></p>\n<p>\n The pharmacy is located on the 3rd floor at the University of Nairobi, College of Health Sciences in Kenyatta National and Referral Hospital in Nairobi along Ngong Road. This pharmacy space measures approximately 24 square meters and is divided into pharmacy office and the vaccine (IP) pharmacy. The IP pharmacy has a Sanyo MDF -80°C freezer, a Panasonic -80°C freezer, a Sanyo 2-8 refrigerator, a class II biosafety cabinet, open shelves and a lockable cabinet which act as room temperature storage unit. The room has an air conditioner unit for ambient temperature regulation. All these units are powered by the mains electricity but there exists a UPS and two generators on site which work as back-up facilities. </p>\n<p>\n Transmitters connected to the freezer, fridge and the lockable cabinet send data to the pharmacy computer, which is programmed to call relevant staff in the event of temperature excursions or power failure, and which downloads the temperature data stored in the Eltek Temperature Monitoring system. Room temperature can also be controlled in a similar manner. Access to the pharmacy is restricted and is limited to the pharmacy staff by the use of magnetic access cards. All visitors to the pharmacy must sign a visitor’s log and must be accompanied by at least one of the pharmacy staff. Security of the entire site including the pharmacy, is maintained by the University of Nairobi security staff. A back-up pharmacy is available at the KAVI-Kangemi site for emergency transfer of the Investigational Products in case of catastrophic power failure. Monitoring of the pharmacy activities is usually conducted by a single monitor facilitated by the study sponsor. Pharmacy staff who are un-blinded do not participate in the safety assessment of volunteers. </p>\n<p>\n <strong>Laboratory</strong></p>\n<p>\n The main lab occupies the 2^nd floor of the KAVI-ICR building at the College of Health sciences (University of Nairobi) and it is accredited to Good Clinical Laboratory Practice standards (GCLP). The laboratory is also registered with KMLTTB (Kenya Medical Technicians and Technologists Board) which is the regulatory body under Ministry of Health, Kenya governing all diagnostic and clinical research laboratories in the country. The lab has capacity to perform HLA molecular tissue typing, serological assays for HIV, HBV, and HCV (using ELISA) and RPR (syphilis), hematology (CBC and differential), biochemistry (liver and renal function tests), urinalysis, and pregnancy tests, PCR tests (CT/NG, HIV Viral Load), PBMC separation, intracellular cytokine staining, mucosal sample processing, ELISpot, FlowCytometry, HIV Viral mobility assays and a variety of basic immunological assays e.g. B cell sorting and antibody response determination. There is ongoing capacity building to improve the ability to conduct COVID-19 related trials. Turn-around time for results is approximately 3 days but more critical results can be provided within 24hours.</p>\n<p>\n KAVI-ICR has engaged the services of the Pathologists LANCET Kenya laboratories as a back-up and referral to the main KAVI lab.</p>\n<p>\n <strong>Data Management</strong></p>\n<p>\n Data management is mainly through online and offline data capture system and datafax. In addition to the electronic swipe cards that limit access to the data office, access to the database is password controlled and staff have limited access levels to the database. Study documents that contain volunteer identifiers are stored separately in fireproof cabinets located in a different office within the site facilities. There are 2 computers dedicated to data entry. During power outages, all critical operations are supported by a diesel-powered generator and a UPS system. The site has data management SOPs including data backup and disaster management. Off-site long-term archiving of study documents is outsourced to a company called The Filing Room. </p>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.<br />\n  </p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • 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_states4
      • number_of_sites7
      • multi_country_listAustralia\nKenya\nMexico\nTurkey\nNew Zealand
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment with 2-6 participants per site
      • total_participants_worldwide160
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • 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_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center, PO Box 088 30100, Nandi Road, Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n Dear PPB Reviewer,</p>\n<p>\n We hereby wish to respond to the second Screening Queries for the site of Prof Omu Anzala: ECCT/25/02/06.</p>\n<p>\n The cover letter and additional documents have been added under Section 13, Checklist. </p>\n<p>\n  </p>\n<p>\n Kind regards</p>\n<p>\n Gerald Carstens</p>\n
      • approval_date06-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonWe appreciate that the study has been approved for other sites where original application was made to PPB. After review of this application and the Site-Specific Addendum, PPB is satisfied and approves clinical study activities at Kenya AIDS Vaccine Initiative (KAVI) Institute of Clinical Research, Nairobi
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:27:29
      • created2025-02-07 14:01:13
      • total_sites1
      • ecitizen_invoice354576
    • InvestigatorContact(array)
      • 0(array)
        • id1228
        • application_id1514
        • given_nameOmu
        • middle_name
        • family_nameAnzala
        • qualificationMBChB, Dip Epidemiology, M Infectious Diseases, PhD, Postdoctoral IMM
        • professional_addressKAVI-Institute of Clinical Research (KAVI - ICR), Faculty of Health Science, University of Nairobi, KNH Complex, Off Mbagathi Way, P.O. Box 19676-00202, Nairobi, Kenya
        • telephone+254 20 2717 694
        • emailoanzala@kaviuon.org
        • created2025-02-07 14:01:13
        • modified2025-02-24 16:38:46
    • SiteDetail(array)
      • 0(array)
        • id1841
        • application_id1514
        • county_id47
        • site_nameKAVI-Institute of Clinical Research (KAVI - ICR)
        • physical_addressFaculty of Health Science, University of Nairobi, KNH Complex, Off Mbagathi Way, P.O. Box 19676-00202, Nairobi, Kenya
        • contact_detailsTel: +254 20 2717694, P.O. Box 19676
        • contact_personProf Omu Anzala
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:38:46
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id806
        • application_id1514
        • sponsorSponsor: Antiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberNA
        • cell_number+1 408 401 6086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:49
        • modified2025-02-24 16:38:46
  • 2(array)
    • Application(array)
      • id1515
      • user_id908
      • trial_status_id4
      • abstract_of_study<p>\n Human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI), and it is estimated that ~85% of all women will be infected during their lifetime. While most HPV infections are transient and clear within a couple of years, persistent hrHPV types are associated with 95% of cervical cancer cases, with genotypes 16 and 18 being the most common. Worldwide, the overall burden of cervical cancer and related deaths ranks fourth among all cancers for women. In Sub-Saharan Africa, cervical cancer continues to be a significant health burden. In 2023, estimates show up to 5236 new cases of cervical cancer in Kenya. Over 60% of the cases were related to HPV 16 and 18. Anecdotal evidence suggests that the burden cuts across the country and is more pronounced in rural Kenya; western Kenya included; where resources are more scarce. Current management guidelines call for expectant management and re-testing in 12 months for hrHPV-positive (hrHPV+) women without evidence of high-grade cervical dysplasia (i.e., CIN2/3) or malignancy. This means women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix.</p>\n<p>\n The study drug, ABI-2280, is a pro-drug of a potent human DNA polymerase inhibitor, for topical intravaginal treatment of several precancerous and potentially precancerous conditions related to human papillomavirus (HPV) infection, including persistent hrHPV infection in women. This Phase 1b/2 placebo-controlled global, multi-centre study will primarily evaluate the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. A total of 160 patients will be enrolled globally.</p>\n<p>\n The primary endpoint in the sentinel cohorts (first 8 subjects of each cohort) will be the incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo. The primary endpoint of the full expanded cohorts (i.e., all 40 subjects in the cohort) will be to evaluate clearance of the hrHPV infection at Week 12. As there are currently, no approved treatments for hrHPV infections, findings from this study will be key in providing an option for treating persistent hrHPV infection before progression to the pre-cancerous stage and ultimately to cervical cancer.</p>\n<p>\n  </p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts</p>\n
      • laymans_summary<p>\n Human Papillomavirus (HPV) is a common virus that can affect both men and women. There are several types of HPV, with some considered high-risk for causing cancers, particularly cervical cancer in women. High-risk HPV (hrHPV) infections are a global health concern. These infections are often spread through intimate contact and can persist for years without causing symptoms. In some cases, however, hrHPV infections can lead to the development of cancers, including cervical cancers. Globally, hrHPV is a widespread issue. It is estimated that over 80% of sexually active individuals may acquire an HPV infection at some point in their lives. Cervical cancer, primarily caused by hrHPV, is a leading cause of cancer-related deaths among women in many parts of the world, particularly in low- and middle-income countries where access to screening and preventive measures is limited.</p>\n<p>\n There are currently no treatments options for persistent hrHPV, and women are essentially asked to “wait and see” if their hrHPV infections resolve, persist, or progress to pre-cancer or cancer of the cervix. A topical treatment that is safe and effective in clearing persistent hrHPV would be beneficial in not only preventing progression of infection to pre-cancer and cervical cancer, but also in reducing potential transmission of the virus. The study drug, ABI-2280 is an experimental drug, developed to treat persistent hrHPV infection. The purpose of this study is to identify the effect, good or bad of ABI-2280 while identifying the highest tolerated dose. This will be compared against placebo to tell how well ABI-2280 works against hrHPV. Placebo is an inactive substance that contains no active ingredient but looks like the study drug. A total of 160 participants will be enrolled globally across 5 countries. Participants will be allocated by chance to receive ABI-2280 (3 out of 4 chance) or placebo (1 out of 4 chance) and assigned to one of up to 11 treatment groups where different doses may be evaluated.</p>\n<p>\n Subject participation will involve a combination of visits to the clinic and wellness visits (contact by telephone, email, or text) over approximately 30 weeks total and a final follow-up visit at Week 52 (about one year after the first dose). Some of the risks of participating in the study include mild to severe side effects of the study drug. These will be closely monitored by the study team. Although the study drug may or may not benefit the participants, information learned may help guide the treatment of other patients with persistent hrHPV infection. The results of the study will be shared openly and information on the trial provided to healthcare professionals and to the public, at scientific congresses, in clinical trial registries, and in peer-reviewed journals. The results will also be shared with the study participants.</p>\n
      • short_titleClearance of High-Risk HPV
      • protocol_noECCT/25/02/08
      • version_no3.0
      • date_of_protocol09-05-2024
      • study_drugABI-2280 Vaginal Insert
      • disease_conditionHuman papillomavirus (HPV) infection
      • 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_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressssusa.submissions@iconplc.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_applicantGerald Carstens
      • declaration_date124-02-2025
      • declaration_principal_investigatorProf. Fredrick Chite Asirwa (NPI); Dr Valentine Chepkorir Sing’oei (PI)
      • declaration_date224-02-2025
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Objectives: </strong></p>\n<p>\n For sentinel cohorts: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate type-specific hrHPV DNA test negativity at Week 12 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Secondary Objectives:</strong></p>\n<p>\n For fully expanded cohorts, including sentinel: To assess the safety and tolerability of various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo. </p>\n<p>\n For fully expanded cohorts, including sentinel: To evaluate persistence of type-specific hrHPV DNA test negativity at Week 24 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n <strong>Exploratory Objectives:</strong></p>\n<p>\n To evaluate persistence of type-specific hrHPV DNA test negativity at Week 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test and extended genotyping as needed. </p>\n<p>\n To explore hrHPV DNA test negativity for persistent cervical hrHPV genotypes 16 (HPV-16) and/or 18 (HPV-18) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert, as assessed by an HPV DNA test and extended genotyping as needed.</p>\n<p>\n To evaluate complete hrHPV DNA test negativity (i.e., absence of detectable hrHPV DNA for any genotype) at Weeks 12, 24, and 52 following treatment with various doses and dosing regimens of ABI-2280 Vaginal Insert vs. placebo, as assessed by an HPV DNA test.</p>\n
      • principal_inclusion_criteria<p>\n 1. Female sex, 25 to 55 years of age (inclusive).</p>\n<p>\n 2. Able and willing to provide informed consent.</p>\n<p>\n 3. Positive hrHPV result on at least 2 consecutive tests prior to randomization:</p>\n<p>\n a. One hrHPV+ result at least 12 months prior to screening</p>\n<p>\n b. A second hrHPV+ result at screening, as measured using the Roche cobas® HPV test. </p>\n<p>\n Any intervening hrHPV tests between (a) and (b) must all be positive in order to be eligible.</p>\n<p>\n Approximately 33% of participants enrolled shall have HPV-16 and/or -18, although the quota may be adjusted while the study is ongoing at the Sponsor’s discretion.</p>\n<p>\n 4. Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.</p>\n<p>\n 5. Generally, in good health, with no clinically significant pulmonary, cardiac, gastrointestinal, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease. Medical conditions that are not severe, are well-controlled, and stable are acceptable with the approval of the Medical Monitor.</p>\n<p>\n 6. Able and willing to abstain from vaginal douching, insertion of any vaginal products other than the investigational product (study drug and retaining device/vaginal applicator), and sexual intercourse for 48 hours prior to dosing and 48 hours after each dose, for the duration of study medication administration.</p>\n<p>\n 7. Must agree to use highly effective contraception as defined by Clinical Trials Facilitation and Coordination Group guidance (Version 1.1, 21 Sep 2020) starting at screening and continuing throughout the study. Under the guidance of the Principal Investigator (PI), participants will be informed of reliable birth control methods to include oral, transdermal, injectable or implantable hormonal contraceptives; long-acting reversible contraceptive methods; complete (not periodic abstinence); or permanent sterilization. Intrauterine devices (IUDs) are acceptable but should be inserted at least 1 month prior to enrollment; however, the use of vaginally administered contraception methods such as a spermicide or Nuvaring® are not allowed.</p>\n<p>\n 8. Generally experiencing regular menstrual cycles (as determined by the PI), unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant, continuous oral contraceptives) or post-menopausal. Post-menopausal participants must be without evidence of genitourinary atrophy. Women with prolonged amenorrhea due to other causes (e.g., athletes, perimenopause) may also be eligible with the approval of the Medical Monitor.</p>\n<p>\n 9. Willing to provide access to medical records consisting of hrHPV test results and pathology reports, if available.</p>\n<p>\n 10. Willing to defer HPV vaccination until after the Week 24 EOS/Early Termination (ET) visit.</p>\n<p>\n 11. Able and willing to adhere to protocol-specified assessments and procedures, including ability and willingness to use a retaining device or vaginal applicator as directed in the participant instructions for use by Day 1.</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n 1. History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia.</p>\n<p>\n 2. Women who are pregnant, plan to become pregnant in the next 6 months, or lactating females.</p>\n<p>\n 3. History of cancer, except basal cell or squamous cell carcinoma of the skin.</p>\n<p>\n 4. History of genital herpes with outbreak within 6 months prior to Day 1, or active non-HPV vaginal infection.</p>\n<p>\n 5. Have an active pelvic infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).</p>\n<p>\n 6. Current or recent (within 6 weeks of Day 1) abnormal vaginal discharge and/or abnormal vaginal bleeding.</p>\n<p>\n 7. Had a therapeutic abortion or miscarriage less than 6 weeks prior to Day 1.</p>\n<p>\n 8. Any clinically significant immune suppressing condition.</p>\n<p>\n 9. Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.</p>\n<p>\n 10. Use of topical imiquimod, 5-fluorouracil or other antiviral/antiproliferative therapies in the genital area within 3 months prior to Day 1.</p>\n<p>\n 11. Taking any of the following medications: corticosteroids (non-systemic corticosteroids are allowed), immunomodulatory treatments, any prescription that in the opinion of the Investigator could interfere with the interpretation of the results, or any over-the-counter intravaginal preparation within 2 weeks of Day 1.</p>\n<p>\n 12. Hypersensitivity to any component of the product formulation excipients and/or other nucleoside analogues (such as cidofovir, etc.).</p>\n<p>\n 13. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of Day 1.</p>\n<p>\n 14. Known to be positive for human immunodeficiency virus.</p>\n<p>\n 15. Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) within the last 3 months prior to Day 1.</p>\n<p>\n 16. History or current diagnosis of cervical cancer, suspected or confirmed.</p>\n<p>\n 17. History of hysterectomy; patients who have undergone subtotal/supracervical hysterectomy and have a residual cervix that does not preclude appropriate placement of a retaining device or sampling of the endocervix for hrHPV may be eligible.</p>\n<p>\n 18. Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study. </p>\n<p>\n  </p>\n
      • primary_end_points<p>\n For sentinel cohorts:</p>\n<p>\n For each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.</p>\n<p>\n For fully expanded cohorts, including sentinel:</p>\n<p>\n For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 12 as assessed by an HPV DNA test (e.g., Roche cobas®) and extended genotyping (e.g., Seegene) as needed.</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase 1b/2
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kombewa CRC has adequate staff and facilities to conduct the trial. The site has the following cadres of staff; 4 pediatricians, 4 medical offices, 1 regulatory officer, 5 study coordinators, 6 clinical officers, 7 Lab technologist, 9 nurses, 1 pharmacist, 2 pharmaceutical technologist, 6 data clerks and 38 field workers. The unit has a two-story building consisting of office space, laboratory, clinical rooms, pharmacy, emergency room, observation room and records storage rooms.</p>\n<p>\n Key departments:</p>\n<ul>\n <li>\n <strong>Health Demographic Surveillance System (HDSS):</strong>\n <ul>\n <li>\n The <strong>DRIVING</strong> force of study recruitment for Kombewa CRC</li>\n <li>\n Bio-surveillance platform within Kisumu County</li>\n <li>\n HDSS uses meta-data and other identifiers to build a surveillance map using ArcGIS software (granular, longitudinal geographic, behavioral, & demographic data)</li>\n <li>\n Has been successful in maintaining recruitment & retention rates for various clinical trials (over 90%)</li>\n <li>\n ONLY surveillance platform of Kisumu Field Station facilities</li>\n </ul>\n </li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n <strong>Pharmacy:</strong>\n <ul>\n <li>\n Fully equipped to run double-blinded studies</li>\n <li>\n Located adjacent to the consult rooms with dispensing windows for blinded IP (investigational product) delivery</li>\n <li>\n Stocks basic medications to treat routine illnesses</li>\n <li>\n Nearby access to refrigerators (2-8°C) and freezers (-20°C to -80°C) with remote monitoring</li>\n </ul>\n </li>\n <li>\n <strong>Laboratory (meets GCLP standards but is not ISO 15189 or CAP-accredited): below are tests conducted by the lab </strong>\n <ul>\n <li>\n Chemistry</li>\n <li>\n Hematology</li>\n <li>\n Immunology (includes PBMC processing; HBV/HCV serology)</li>\n <li>\n Malaria microscopy</li>\n <li>\n Microbiology</li>\n <li>\n GeneXpert Tuberculosis</li>\n </ul>\n </li>\n <li>\n PBMC (peripheral blood mononuclear cells)</li>\n <li>\n RPR (syphilis)</li>\n <li>\n ELISA\n <ul>\n <li>\n HIV</li>\n <li>\n Hepatitis B</li>\n <li>\n Hepatitis C</li>\n </ul>\n </li>\n <li>\n MTB (tuberculosis)</li>\n <li>\n CRAg (cryptococcal)</li>\n <li>\n Urinalysis</li>\n <li>\n HCG - Urine or Blood (pregnancy)</li>\n <li>\n CCA (Schistosomes)</li>\n <li>\n Malaria</li>\n <li>\n CD4 counting</li>\n <li>\n Serum for IgG/IgA will be stored</li>\n <li>\n CBC with differentials</li>\n <li>\n Blood chemistries - 22 analytes: ALT, AST, ALP, Bilirubin, Electrolytes, etc.</li>\n <li>\n Cultures: Blood, Stool, Urine, CSF, Pus Swabs, etc.</li>\n <li>\n Bacterial identification (Gram +ve/-ve)</li>\n <li>\n Antimicrobial sensitivity</li>\n <li>\n INR</li>\n</ul>\n<p>\n The site has 4 laboratories i.e. clinical, microbiology, microscopy and immunology. The lab is equipped with eight -80c freezers with remote temperature monitoring system.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n There is a plan to conduct the study in the United States, the host country of the sponsor.  Currently, the sponsor is discussing the clinical/nonclinical and manufacturing development plan with the US FDA.  The outcomes of these discussions will determine the timing of the submission of a US IND to the FDA.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n The submission to the Turkey MoH occurred on 27 June 2024.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n 1. New Zealand MedSafe approval dated 04 Jun 2024. Number of sites: 8</p>\n<p>\n 2. Australia TGA approval/acknowledgement dated 13 Feb 2024. Number of sites: 1</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n<p>\n  </p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n<p>\n  </p>\n
      • estimated_duration2 years starting April 2024
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo Vaginal Insert
      • 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_states4
      • number_of_sites7
      • multi_country_listAustralia \nKenya \nMexico \nNew Zealand \nTurkey
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrolment. 2-6 participants per site
      • total_participants_worldwide160
      • 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_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_nameFredrick
      • investigator1_middle_nameChite
      • investigator1_family_nameAsirwa
      • investigator1_qualificationMBChB
      • investigator1_professional_addressInternational Cancer Institute (ICI) Research, Training and Development Center, PO Box 088 30100, Nandi Road Eldoret, Kenya
      • investigator1_telephone+254 700 522 149
      • investigator1_emailchite@intercancer.com
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n Dear PPB Reviewer,</p>\n<p>\n The application for Dr Valentine C. Sing'oei (ECCT/25/02/08) has been re-submitted, including a cover letter and additional documents as requested in the Second Screening Queries.</p>\n<p>\n <strong>Please note that the PI's surname is Sing'oei</strong>, not Chepkorir.  </p>\n<p>\n Thank you for your review.</p>\n<p>\n Kind regards</p>\n<p>\n Gerald Carstens</p>\n
      • approval_date06-03-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted07-02-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved after satisfactory screening feedback. We appreciate that the study has been approved for other sites where original application was made to PPB. After review of this application and the Site-Specific Addendum, PPB is satisfied and approves clinical study activities at this site.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-17 17:26:07
      • created2025-02-07 14:01:51
      • total_sites1
      • ecitizen_invoice354577
    • InvestigatorContact(array)
      • 0(array)
        • id1229
        • application_id1515
        • given_nameValentine
        • middle_nameChepkorir
        • family_nameSing’oei
        • qualificationMaster\'s in Public Health, MBChB
        • professional_addressKEMRI–USAMRD-A, Kombewa Clinical Research Centre, Off Kisumu-Bondo Road, Opposite Kombewa County Hospital, P.O. Box 54-40100, Kisumu, Kenya
        • telephone+254 726 502 606
        • emailvalentine.singoei@usamru-k.org
        • created2025-02-07 14:01:51
        • modified2025-02-24 17:07:28
    • SiteDetail(array)
      • 0(array)
        • id1840
        • application_id1515
        • county_id42
        • site_nameKEMRI –USAMRD-A, Kombewa Clinical Research Centre
        • physical_addressOff Kisumu-Bondo Road, Opposite Kombewa County Hospital, P.O. Box 54-40100, Kisumu, Kenya
        • contact_details+254 726502606, PO Box 54
        • contact_personDr. Valentine Sing’oei
        • site_capacity(null)
        • misc(null)
        • created2025-02-07 14:11:48
        • modified2025-02-24 17:07:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id805
        • application_id1515
        • sponsorAntiva Biosciences, Inc.
        • sponsor_typeIndustry
        • contact_personAnnie Warsi, MD MAS
        • address555 Twin Dolphin Drive, Suite 620 Redwood City, CA, 94065
        • telephone_number+16508221400
        • fax_numberN/A
        • cell_number+1 4084016086
        • email_addressawarsi@antivabio.com
        • created2025-02-07 14:11:48
        • modified2025-02-24 17:07:28
  • 3(array)
    • Application(array)
      • id821
      • user_id43
      • trial_status_id9
      • abstract_of_study<p>\n <strong> Broad Objectives: </strong></p>\n<p>\n To determine if HPV vaccination reduces the occurrence of cervical HSIL among HIV-infected women participating in anHPV test-and-treat strategy for cervical cancer prevention.</p>\n<p>\n <strong>Specific Objectives:</strong><br />\n •To describe occurrence of cervical HSIL from week 52 to</p>\n<p>\n week 104.</p>\n<p>\n •To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment,including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA,ART use, age, sexual behavior, and vaccination use.</p>\n<p>\n •To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results.</p>\n<p>\n •To describe prevalent and incident vulvar HSIL or cancer in this population.</p>\n<p>\n  </p>\n<p>\n <strong>Study setting: </strong>[  MTRH Chandaria Cancer and Chronic Disease Centre, Cervical Cancer Screening Clinic]</p>\n<p>\n <strong>Study population: </strong>[HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer.</p>\n<p>\n <strong>Number of subjects to be contacted: </strong></p>\n<p>\n 536 participants</p>\n<p style=\"margin-left:-21.3pt;\">\n <strong>Stu  Study procedures (main) done on participants: </strong></p>\n<p>\n Potential participants will be tested for cervical human papillomavirus</p>\n<p>\n (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo.</p>\n<p>\n Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical Cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52,and 104</p>\n
      • study_title<p>\n A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT)</p>\n
      • laymans_summary<p>\n HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history</p>\n<p>\n of cervical, vulvar, or vaginal cancer. Participants must be HPV-positive by GeneXpert hrHPV assay with HPV16, 18/45, or 31/33/35/52/58 detected. Participants must not have had a hysterectomy, prior treatment for cervical HSIL or prior HPV vaccination.</p>\n<p>\n <strong>Regimen:</strong></p>\n<p>\n Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXperthrHPV assay and HPV DNA PCR)</p>\n<p>\n and undergo cervical colposcopy. If eligible the participant will be randomized to receive either the 9-valent HPV vaccine or saline</p>\n<p>\n placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series.At week 4, participants will have</p>\n<p>\n cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate.</p>\n<p>\n Participants undergoing cervical cryotherapy will have cervical biopsies obtained just prior to the</p>\n<p>\n treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well</p>\n<p>\n as with cytology and cervical colposcopy with biopsies at week 26, 52, and 104.</p>\n
      • short_titleAMC-099
      • protocol_noECCT/19/10/01
      • version_noVersion 3
      • date_of_protocol01-08-2018
      • study_drugGardasil 9
      • disease_conditionCervical Cancer
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamckenya@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDR. OMENGE ORANGO
      • declaration_date123-08-2019
      • declaration_principal_investigatorDR. NAFTALI BUSAKHALA
      • declaration_date223-08-2019
      • placebo_presentYes
      • study_objectives<div>\n Primary Objective</div>\n<div>\n <ol>\n <li>\n To determine if HPV vaccination reduces the occurrence of cervical HSIL among HIV-infected women participating in an HPV test-and-treat strategy for cervical cancer prevention.</li>\n </ol>\n</div>\n<div>\n Secondary Objectives</div>\n<ol>\n <li>\n To describe occurrence of cervical HSIL from week 52 to week 104.</li>\n <li>\n To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment, including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA, ART use,age, sexual behavior, and vaccination use.</li>\n <li>\n To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results.</li>\n <li>\n To describe prevalent and incident vulvar HSIL or cancer inthis population.</li>\n</ol>\n
      • principal_inclusion_criteria<ol>\n <li>\n HIV-1 infection</li>\n <li>\n <p>\n HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected. <u>Note</u>: Participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible.</p>\n </li>\n <li>\n <p>\n Age ≥ 25 years.</p>\n </li>\n <li>\n <p>\n Receipt of ART for at least 180 days prior to randomization.</p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study.</p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n <o:p>If the participant is of childbearing potential, she should be at least 3 months postpartum.</o:p></p>\n </li>\n <li>\n <p class=\"Level3Heading\">\n Karnofsky score <u>></u>70%.</p>\n </li>\n <li>\n <p>\n  </p>\n <p class=\"Level3Heading\">\n  Ability to understand and the willingness to sign a written informed consent document.</p>\n <p class=\"Level3Heading\">\n  </p>\n <br />\n  </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Current STI requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider).</li>\n <li>\n History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9.</li>\n <li>\n Uncontrolled intercurrent illness that would limit compliance with study requirements.</li>\n <li>\n Prior hysterectomy with removal of the cervix.</li>\n <li>\n Prior treatment for cervical HSIL.</li>\n <li>\n Prior history of cervical, vulvar, or vaginal cancer.</li>\n <li>\n Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer.</li>\n <li>\n Known bleeding diathesis.</li>\n <li>\n Prior HPV vaccination</li>\n <li>\n Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents.</li>\n <li>\n Documentation of WHO Clinical Stage 3 or 4 condition within 6 months of entry.</li>\n <li>\n CD4 count <200 cells/mm³ within 6 months of entry.</li>\n</ol>\n
      • primary_end_points<p class=\"Bodytextlevel3\">\n Cervical HSIL or invasive cervical cancer diagnosed after the week 4 visit through week 52 post-randomization.<o:p></o:p></p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>taff</u></p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Naftali Busakhala MBChB, MMed, Site Investigator</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Dr. Omenge Orango, MBChB, MMed, Prinicipal Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Peter Itsura - MBChB, MMed- Investigator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Gabriel Kigen, B Pharm, Pharmacist of Record</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Job Kisuya, PhD - Site Coordinator</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Seth Kirui, Bsc - Data Manager</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Joyce Musimbi, Bsc - Research Assistant</p>\n<p style=\"margin-left:5.2pt;\">\n  </p>\n<p style=\"margin-left:5.2pt;\">\n David Oduori - Recruitment Officer</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Simon Wachira, B Pharm- Back-up Pharmacist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n Fred Kiplagat, Dip Pharm- Back-up Pharmaceutical Technologist</p>\n<p>\n  </p>\n<p style=\"margin-left:5.2pt;\">\n <u>S</u><u>ite/Emergency Facilities:</u></p>\n<p>\n  </p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Program– Has 24 care sites and 34 satellite clinics in North Rift and Western</p>\n<p style=\"margin-left:41.2pt;\">\n Kenya</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Oncology Clinic-Has 1 care site and 4 satellite clinics in North Rift and</p>\n<p style=\"margin-left:41.2pt;\">\n Western</p>\n<p style=\"margin-left:23.2pt;\">\n ·    AMPATH Reference Laboratory and MTRH histopathology Laboratory</p>\n<p style=\"margin-left:23.2pt;\">\n ·    Moi Teaching and Referral Hospital (MTRH)- Second largest referral Hospital in Kenya.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Eldoret, Kenya is one of the Africa AMC sites. When protocols are developed by the AMC, sites express interests considering the patient population and relevance of the study. Our site expressed interest and was chosen as a participating site.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n AUTHORITY: MOI UNIVERSITY INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE</p>\n<p>\n DATE OF APPROVAL : 2019</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration48
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorGardasil 9 vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMOI UNIVERSITY CLINICAL RESEARCH CENTER
      • single_site_physical_addressCHANDARIA CANCER AND CHRONIC DISEASE CENTRE, NANDI ROAD
      • single_site_contact_personDR. NAFTALI BUSAKHALA
      • single_site_telephone0722496933
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites
      • multi_country_listKENYA: MOI UNIVERSITY CLINICAL RESEARCH CENTER UGANDA: UGANDA CANCER INSTITUTE ZIMBABWE: UNIVERSITY OF ZIMBABWE SOUTH AFRICA: WITWATERSRAND UNIVERSITY, TANZANIA: BUGANDO MEDICAL CENTER, MALAWI: UNC PROJECT
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide536
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • 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_nameNAFTALI
      • investigator1_middle_nameWISINDI
      • investigator1_family_nameBUSAKHALA
      • investigator1_qualificationMBCHB, MMED
      • investigator1_professional_address4606
      • investigator1_telephone0722496933
      • investigator1_emailnbusakahala@yahoo.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date01-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-03-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy Approved
      • final_report<p>\n A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT). </p>\n<p>\n HIV-infected females 25 and older, currently receiving antiretroviral therapy for at least 6 months with no prior history of cervical, vulvar, or vaginal cancer. Participants must be HPV-positive by GeneXpert hrHPV assay with HPV16, 18/45, or 31/33/35/52/58 detected. Participants must not have had a hysterectomy, prior treatment for cervical HSIL or prior HPV vaccination.</p>\n<p>\n Potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo. Participants will return 4 and 26 weeks later to complete the vaccination (or placebo) series. At week 4, participants will have HPV testing, cervical colposcopy, and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies obtained just prior to the treatment. Participants will be followed with HPV testing (GeneXpert and HPV DNA PCR) at week 26, 52, 78, and 104, as well as with cytology and cervical colposcopy with biopsies at week 26, 52, and 104.</p>\n
      • implication_results<p>\n Not applicable because Moi site will not participate in the study and therefore we are requesting for witdrawal from activation of ECCT/19/10/01 ( AMC-099).</p>\n
      • quantity_importedNone
      • quantity_dispensedNone
      • quantity_destroyedNone
      • quantity_exportedNone
      • balance_siteNone
      • final_date0000-00-00
      • modified2024-06-04 14:23:27
      • created2019-08-23 16:50:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id508
        • application_id821
        • given_nameELKANAH
        • middle_nameORANGO
        • family_nameOMENGE
        • qualificationMBCHB, MMED
        • professional_address4606
        • telephone0722609132
        • emailbworango2000@yahoo.com
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
    • SiteDetail(array)
      • 0(array)
        • id665
        • application_id821
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id396
        • application_id821
        • sponsorNational Cancer Institute Office of HIV and AIDS Malignancy (OHAM)
        • sponsor_typeOthers
        • contact_person
        • address31 Center Drive, Room 3A33 Bethesda, MD, USA 20852-2440
        • telephone_number301-496-4995
        • fax_number
        • cell_number301-496-4995
        • email_addressNCIOHAMContact@mail.nih.gov
        • created2019-08-23 20:40:16
        • modified2020-03-05 10:20:05
  • 4(array)
    • Application(array)
      • id1280
      • user_id263
      • trial_status_id2
      • abstract_of_study<p>\n Etavopivat (FT-4202) is a potent, selective, orally bioavailable, small-molecule activator of pyruvate kinase-red blood cell (PKR) being developed by Forma Therapeutics, Inc and is intended for use as a treatment for patients with sickle cell disease (SCD). The clinical hypothesis is that PKR activation will reduce the rate of sickle cell polymerization and improve red blood cell (RBC) membrane function, thereby reducing RBC sickling and RBC hemolysis that lead to vascular obstruction and anemia, two hallmarks of SCD pathology.</p>\n<p>\n This multi -centre phase 1/2, study aims to evaluate the pharmacokinetics and safety of Etavopivat in SCD patients aged 12 years to below 18 years in a single arm, open label study. This study will enroll 50 patients aged 12 years to below 18 years with SCD. ACTU site will enroll at least 15 participants into the study.</p>\n<p>\n The participants will be seen at the study sites at screening, day 1, week 2, week 4 then approximately every 4 weeks until week 24, then approximately every 8 weeks until week 96, which is the end of treatment. End of study visit will occur 4 weeks after the last full dose with a tolerant window of 1week. Safety will be monitored throughout the study, and PK, QoLs, and clinical outcome measures will be performed at specified visits.</p>\n<p>\n 8. INTRODUCTION</p>\n<p>\n Currently, therapeutic treatment of SCD is inadequate. Potentially curative therapies, such as bone marrow transplant or gene therapies, are invasive and such high-risk procedures are limited to only a subset of patients. For most patients, treatment involves supportive care for management of vaso-occlusive crisis (VOC) or the use of hydroxyurea (HU), to stimulate production of fetal Hb (HbF) and reduce Hb polymerization. While inducing HbF can be effective therapeutically, HU can be myelosuppressive and is a teratogen (Sampson et al. 2010). Although HU is considered to have an acceptable therapeutic index, the myelosuppressive and teratogenic risks limit its effectiveness (Platt 2008).</p>\n<p>\n Chronic transfusion is another way of preventing stroke recurrence in patients with SCD. However, frequent transfusion is associated with significant co-morbidities, such as secondary hemochromatosis; cardiomyopathy and infections; alloimmunization; social and family burden (Franke 2018). An oral therapy reducing the need for RBC transfusion and the associated iron overload, would therefore address a critical unmet medical need for patients with SCD on chronic transfusions for prevention of stroke recurrence.</p>\n<p>\n FT-4202 is a potent, selective, orally bioavailable, small-molecule activator of pyruvate kinase-red blood cell (PKR). Pyruvate kinase R (PKR) is the isoform of pyruvate kinase expressed in RBCs and is a key enzyme in glycolysis (Zanella et al. 2005). Activation of PKR is proposed to directly target both sickling by reducing deoxy-HbS and hemolysis by improving RBC membrane integrity. Specifically, PKR activation inhibits Hb deoxygenation and sickling by decreasing levels of the glycolytic intermediate 2,3- diphosphoglycerate (2,3-DPG) and increasing O2 affinity of HbS. Furthermore, PKR activation increases adenosine triphosphate (ATP), which has been shown to support overall RBC membrane integrity and stress resilience (Betz et al. 2009), thus potentially decreasing hemolysis. ATP also supports elimination of reactive oxygen species (ROS) which damage RBCs and impair their functionality, and reduces vascular adhesion associated with membrane injuries (Banerjee and Kuypers 2004). The combination of antisickling effects, decreased hemolysis, and improved RBC membrane fitness is proposed to reduce the onset and complications of vaso-occlusive events and, in parallel, address the chronic anemia of SCD</p>\n<p>\n A First-in-Human (FIH) clinical study (Protocol 4202-HVS-101) entitled “A Randomized, Placebo-controlled, Double Blind, Single Ascending and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of FT-4202 in Adult Healthy Volunteers and Sickle Cell Disease Patients” has completed enrollment. A total of 90 healthy subjects and 42 SCD patients had been enrolled in the study, including 32 healthy subjects and seven SCD patients in the single ascending dose (SAD) cohorts, 48 healthy subjects and three SCD patients in the multiple ascending dose (MAD) cohorts, and 10 subjects in the food effect (FE) cohort. The 42 SCD patients were enrolled 7 in the SAD cohort,14 in the MAD cohort and 15 in the 12-week open label.</p>\n<p>\n For the healthy subject SAD cohorts, a total of 6 (18.8%) subjects were reported with at least one treatment-emergent adverse event (TEAE), including 5 (20.8%) subjects who received FT-4202 and 1 (12.5%) subject who received placebo. No TEAE was reported in more than 1 subject. No treatment-emergent serious adverse events (TESAEs) were reported and there were no TEAEs that led to dose reduction/interruption or discontinuation of study drug.</p>\n<p>\n For the healthy subject MAD cohorts, a total of 18 (37.5%) subjects were reported with at least one TEAE, including 15 (41.7%) of subjects who received FT-4202 and 3 (25.0%) subjects who received placebo. The most common TEAE was headache, which was reported in 10 (27.8%) subjects receiving FT-4202 and 2 (16.7%) subjects receiving placebo. For headache TEAEs, there was no apparent relationship between daily FT-4202 exposure and incidence. For subjects receiving FT-4202, all other TEAEs were reported in 1 (2.8%) subject each. No TESAEs were reported and there were no TEAEs that led to dose reduction/interruption or discontinuation of study drug.</p>\n<p>\n For the SCD SAD cohort, TEAEs were reported in 2 (100.0%) patients who received placebo and 2 (40.0%) patients who received Etavopivat. For patients who received Etavopivat, 1 TEAE of transient, mild (Grade 1) palpitations was considered possibly treatment-related and resolved without treatment. For the SCD SAD cohort, no TESAEs were reported, and there were no TEAEs that led to dose reduction/interruption or discontinuation of study drug.</p>\n<p>\n For the SCD multiple dose cohorts, TEAEs were reported in 7 (87.5%) patients who received Etavopivat in the MAD-1 cohort (300 mg Etavopivat × 14 days), 6 (75.0%) patients who received Etavopivat in the MAD-2 cohort (600 mg of Etavopivat × 14 days), and 14 (93.3%) patients in the 12-week OL cohort. For patients receiving Etavopivat, treatment-related TEAEs were reported in 2 (25.0%) patients in the MAD-1 cohort and 7 (46.7%) patients in the OL cohort. Treatment-emergent SAEs were reported in 1 (12.5%) patient in the MAD-2 cohort and 5 (33.3%) patients in the OL cohort; 1 (6.7%) patient in the OL cohort had a TEAE that led to study discontinuation (SAE of deep vein thrombosis [DVT]). For patients with SCD receiving Etavopivat in the 14-day cohorts, the TEAEs reported in > 1 patient were sickle cell anemia with crisis (MAD-1, n=3 [37.5%]; MAD-2, n=3 [37.5%]), headache (MAD-1, n=3 [37.5%]; MAD-2, n=1 [12.5%]), nausea (MAD-1, n=2 [25.0%]; MAD-2, n=1 [12.5%]), and vomiting (MAD1, n=1 [12.5%]; MAD-2, n=1 [12.5%]).</p>\n<p>\n In the 12week OL cohort, the TEAEs reported in > 1 patient were sickle cell anemia with crisis (n=7 [46.7%]); headache (n=4 [26.7%]); and dizziness, nausea, and upper respiratory tract infection (n=2 [13.3%] for each). Six patients receiving Etavopivat in the SCD multiple dose cohorts were reported with TESAEs, including 1 (12.5%) patient in the MAD-2 cohort (1 event of unrelated Grade 3 sickle cell anemia with crisis) and 5 (33.3%) patients in the 12-week OL cohort (2 patients with events of unrelated Grade 3 sickle cell anemia with crisis and single-patient events of ACS [unrelated Grade 3], corona virus infection [unrelated Grade 3], DVT [possibly related Grade 3], non-cardiac chest pain [unrelated Grade 3], and syncope [unrelated Grad</p>\n
      • study_title<p>\n A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease</p>\n
      • laymans_summary<p>\n About 300,000 children are born each year with SCD(Sickle Cell Disease). It affects the red blood cells within the blood that carries the important function of transporting oxygen to all body parts. Normal red blood cells have a regular circular shape and it is maintained that way in the body. For patients with SCD, their red blood cell takes the shape of a sickle when the body is stressed and clogs the blood vessels, leading to early destruction of the deformed sickled red blood cell and damage of the body parts because of lack of oxygen. The abnormality and many other processes make it difficult for the sickled red blood cell to transport oxygen. The lack of oxygen in the body parts can cause severe body pains which is a key presentation of SCD. Potential cure for SCD such as bone marrow transplant and gene treatment are limited by their high cost and use of advanced medical technology not available in many countries.. About a quarter of patients with SCD develop stroke by the age of 45 years with a very high likelihood of recurrence. Lifelong blood transfusion can be used to prevent stroke recurrence in patients with SCD who have a stroke by reducing the percentage of sickled haemoglobin to below 30 percent. However, this lifelong transfusion has many challenges such as iron overload, heart problems, social and family burden. Currently there are no treatments approved for the reduction of the transfusion burden in these patients and therefore an oral treatment reducing the need for blood transfusion and its associated iron overload will be key in addressing this unmet need for patients on long term transfusion for prevention of stroke. Another drug that prevents initial stroke in patients with SCD is hydroxyurea but is not well tolerated by some patients thus an unmet need still exists. There are other new drugs which are also being developed and what we are proposing is one of them </p>\n
      • short_titleHibiscus Kid\'s Study
      • protocol_noECCT/23/06/09
      • version_no3.0
      • date_of_protocol01-07-2022
      • study_drugEtavopivat
      • disease_conditionSickle Cell Anaemia
      • 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_nameEtavopivat
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantElizabeth Miron
      • declaration_date130-06-2023
      • declaration_principal_investigatorDr Walter Otieno
      • declaration_date230-06-2023
      • placebo_presentNo
      • study_objectives<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Primary Objectives</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To assess the PK of etavopivat in patients with SCD</li>\n <li style=\"line-height: 20px;\">\n To assess the safety and tolerability of etavopivat during the 24-week primary treatment period</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Secondary Objectives</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n To assess the safety and tolerability of etavopivat during the 72-week treatment extension period</li>\n <li style=\"line-height: 20px;\">\n To assess the effects of etavopivat on hemoglobin (Hb) response</li>\n <li style=\"line-height: 20px;\">\n To describe the occurrence of VOCs in enrolled patients</li>\n <li style=\"line-height: 20px;\">\n To assess changes in fatigue of patients with SCD taking etavopivat</li>\n <li style=\"line-height: 20px;\">\n To assess changes in cerebral blood flow in patients with SCD taking etavopivat</li>\n</ul>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Inclusion Criteria</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Informed Consent</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Patient’s parent, legal guardian, or legal representative has provided documented informed consent and patients have provided age-appropriate assent</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  Age</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. 12 to < 18 years of age</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Type of Participant and Disease Characteristics</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. Patient has confirmed diagnosis of SCD • Documentation of SCD genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing. Molecular genotyping is not required. SCD genotype may be determined from the results of Hb electrophoresis, high-performance liquid chromatography (HPLC), or similar testing. Note that Hb electrophoresis is performed by the local laboratory at Screening.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. Hemoglobin ≥ 5.5 and < 10.5 g/dL</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Adolescent patients with severe SCD, as defined by at least 1 of the following:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Two or more VOCs in the past 12 months, defined as a previously documented episode of acute chest syndrome (ACS) or acute painful crisis (for which there was no explanation other than VOC) which required prescription or healthcare professional-instructed use of analgesics for moderate to severe pain</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Hospitalization for any SCD-related complication in the last 12 months</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Proteinuria, defined as an albumin:creatinine ratio (ACR) > 100 mg/g on 2 measures (separated by ≥ 1 month) as an indicator of early renal disease</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • History of a conditional TCD in the last 12 months, but not currently being treated with chronic transfusion therapy. Conditional TCD is defined as a TAMMV of 170-199 cm/s by TCD or 155-184 cm/s by imaging TCD (TCDi).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6. For participants taking HU, the dose of HU (mg/kg) must be stable (no more than a 20% change in dosing) for at least 90 days prior to start of study treatment with no anticipated need for dose adjustments during the study, in the opinion of the Investigator</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 7. Patients on crizanlizumab or L-glutamine treatment at the time of consent may be eligible if they:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Have been on a stable dose for ≥ 12 months at the time of consent (ie, no changes to the dose except for changes to weight or for safety reasons)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • For patients on crizanlizumab, have been ≥ 80% compliant with the planned regimen during the 12 months prior to the time of consent.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Sex and Contraceptive Requirements</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 8. Patients, who if female and of childbearing potential, are using acceptable methods of contraception and agree not to donate ova from study start to 90 days after the last dose of study drug, and who if male, are willing to use acceptable methods of contraception and agree not to donate sperm, from study start to 90 days after the last dose of study drug.</p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Exclusion Criteria</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Medical Conditions</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Female who is breast feeding or pregnant</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. More than 10 VOCs within the 12 months prior to starting study treatment that required a hospital, ER, or clinic visit</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of Screening</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) > 4 × upper limit of normal (ULN) and/or direct bilirubin > 3 × ULN</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Patients with clinically significant bacterial, fungal, parasitic, or viral infection requiring systemic therapy</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Patients with acute bacterial, fungal, parasitic, or viral infection requiring systemic therapy should delay screening/enrollment until active therapy has been completed</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Patients with acute viral infections (eg, coronavirus disease 2019 [COVID-19]) should delay screening/enrollment until the acute infection has resolved. Note: Infection prophylaxis is allowed (see concomitant medication restrictions)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6. Known human immunodeficiency virus (HIV) positivity</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 7. Known infection with hepatitis B virus (hepatitis B surface antigen [HepBsAg] and hepatitis B core antibody [HepBcAb] positive)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 8. Active Hepatitis C infection</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 9. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit; calculated by the local laboratory) < 30 mL/min/1.73 m2 or on chronic dialysis</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 10. History of malignancy within the past 2 years prior to treatment Day 1 requiring systemic chemotherapy and/or radiation</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Patients with malignancy considered surgically cured are eligible (eg, non-melanoma skin cancer, cancer of the cervix in-situ, ductal carcinoma in situ [stage 1], Grade 1 endometrial cancer)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 11. History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to uncontrolled clinically significant arrhythmias and congenital heart disease requiring treatment. Children with well-controlled asthma are not excluded.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 12. Any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 13. Abnormal TCD in the 12 months prior to starting study treatmen</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Prior/Concomitant Therapy</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 14. Has chronic daily use of opioid analgesia for any reason (defined as opioid use in the majority of the 30 days prior to starting study treatment)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 15. Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 16. Received any blood products within 30 days of starting study treatment</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 17. Receiving or use of concomitant medications that are strong inducers of CYP3A4/5 within 2 weeks of starting study treatment</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 18. Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 19. Receipt of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 20. Receipt of prior cellular based therapy (eg, hematopoietic cell transplant, gene modification therapy)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 21. Patients who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Prior/Concurrent Clinical Study Experience</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 22. Participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of date of last dose prior to date of informed consent, whichever is longer, or is currently participating in another trial of an investigational agent (or medical device)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Other Exclusions</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 23. Inadequate venous access as determined by the Investigator/ site staff.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 24. Medical, psychological, or behavioral conditions, which, in the opinion of the Investigator, may preclude safe participation, confound study interpretation, interfere with compliance, or preclude informed consent</p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Single-dose: maximum concentration (Cmax), area under the concentration time curve (AUC)0-t, AUC0-inf</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Steady-state etavopivat plasma exposure (Cmax,ss, AUCtau,ss, Cavg,ss, Cmin,ss)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Estimated using population PK</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs related to etavopivat</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n • Number of premature discontinuations, dose interruptions, and dose reductions</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyTolerability
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><u><strong>Site # 960 AHERO CLINICAL TRIALS UNIT</strong></u></span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><strong><span lang=\"EN-US\" style=\"line-height: 17.76px;\">Study Site </span></strong></span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The study will be conducted at Ahero Clinical Trials Unit (ACTU), a satellite unit of Centre for Clinical Research of the Kenya Medical Research Institute (KEMRI) and also affiliated to the Center for Research in Therapeutic Sciences (CREATES), Strathmore University. The unit was set up in the year 2008 for the conduct of clinical trials in malaria as the area is within an area of all year transmission of malaria.</span></span><span style=\"font-family: arial, helvetica, sans-serif;\">The site has a well-equipped consultation office with coaches, emergency tray and drugs including oxygen with the ability to manage appropriately medical emergencies. There is also a pharmacy, well equipped laboratory with the ability to perform routine tests and a spacious archive and data entry rooms</span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <strong><span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Staffs</span></span></strong></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.76px;\">The site has 1 PI Dr Bernherads Ogutu, 1 pediatrician  Dr Allan Otieno assisted by 2 medical officers  Dr John Orimbo and Dr Fredrick Olewe. @ Pharmacists Dr. Ruth Wasuna and Dr. Simeon Onyango. A study Coordinator Ms. Cecilia Awino and a number of clinical officers, nurses and laboratory technicians to conduct the clinical trials and offer medical care to research participants.</span></span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Site # 961 Kombewa Clinical Research Centre</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Study Site</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The study will be conducted at the KCRC and recruitment will occur at the Kombewa County hospital and in the surrounding health facilities. The HDSS (Health Demographic Surveillance System) may be used to locate potential participants. The KEMRI/WRP Kombewa Clinical Research Center (KCRC) is designed for large clinical trials and has a full clinical laboratory including microbiology capability.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KCRC is part of The Walter Reed Project (WRP), which is a 40-year collaboration between the Kenya Medical Research Institute, (KEMRI) and the Walter Reed Army Institute of Research (WRAIR). The US Army Medical Research Unit in Kenya (USAMRU-K) is a WRAIR attachment stationed in Kenya with headquarters in Nairobi and field stations in Kericho and Kisumu. WRP-Kisumu conducts a wide spectrum of field and laboratory work including numerous clinical research trials.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Staffs</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The site has 1 PI Dr. Walter Otieno who will be responsible for the overall conduct of the trial at this study site, administrative actions between WRP, Institutional Review Boards, and the sponsor, oversight of field activities and patient care. She contributed to the site protocol development and will contribute to the statistical analysis and writing of the scientific report, 5 associate Investigators, Dr. Jack Hutter, Dr. Janet Oyieko, Dr. Valentine Sing’oei, Dr. Doris Njoroge and Dr. Michal Ohaga who will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of field activities. They will also contribute to the statistical analysis and writing of scientific report(s). 1 Regulatory Affairs oversight Miss Irene Onyango who will be responsible for communication with IRBs and ECs. 1 Clinical Research Coordinator Ms Caroline Laboso who will be responsible for overall study coordination while working in a team environment under the direction of the investigators. Coordinating the recruiting, screening, and enrolling of study volunteers; arranging follow-up visits; completing and ensuring the accuracy of CRFs and regulatory documents; and ensuring the adherence to GCP guidelines. There are also several Clinical Officers, Nurses and Laboratory technologists <span style=\"font-family: arial, helvetica, sans-serif;\">to conduct the clinical trials and offer medical care to research participants</span>.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong><span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><span lang=\"EN-US\" style=\"line-height: 17.76px;\">Site #  962 </span></span></span>KEMRI-Walter Reed-Kericho</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Study Site</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The study will be conducted at KEMRI-Walter Reed-Kericho. The site has a long-standing experience in conducting several studies including clinical trials, ranging from therapeutics that included a study of the safety and impact of broadly neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone or in combination with antiretroviral therapy (ART), vaccines (HIV, Polio, Ebola, Shigella) and cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly, some of which are randomized double blind, placebo controlled and United States Investigational New Drug (IND)/ Food and Drug Administration (FDA)- regulated.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Staffs</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The site has 1 PI Dr. Isaac Tsikhutsu who will be responsible for the overall conduct of the trial at these study site administrative actions between Institutional Review Boards, and the sponsor, oversight of field activities and patient care. He contributed to the protocol development and will contribute to the statistical analysis and writing of the scientific report. 4 Sub-Investigators Dr. Fredrick Sawe, Dr. Deborah Langat,Dr. Josphat Kosgey and Dr. Lucy Koech who will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of field activities. They will contribute to the statistical analysis and writing of scientific report(s). 1 study pahrmacist Dr. Faith Riziki will be responsible for handling of IP including receipt, storage, and dispensing. 1 study coordinator Ms Linet Cherono will be responsible for the regulatory activities of the study. Several clinical officers, nurses and laboratory technologists <span style=\"font-family: arial, helvetica, sans-serif;\">to conduct the clinical trials and offer medical care to research participants</span>.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Site # 963 KEMRI: Siaya Clinical Research Annexe</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Study Site </strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The study will be conducted at the KEMRI CRDR Clinical Research Annexe Siaya  within Siaya County Referral Hospital. KEMRI has a modern research annex at the Siaya County Referral hospital with capacity to conduct phase I to Phase III studies through training and experience.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u><strong>Staffs</strong></u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site investigators responsible for day to day running of the project include: I PI Dr Videlis Nduba who will be responsible for the overall conduct of the trial at this study site, administrative actions between site, Institutional Review Boards, and the sponsor, oversight of site activities and clinical care provision to study participants. He will contribute to the writing of the scientific report. 1 Medical Officer Dr Mercy Mwale who will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of study activities at the site. Reviewing potential Study participants for eligibility, supervising Clinical Officers, review of laboratory results, adverse events and serious adverse events surveillance, documentation and reporting, providing first hand clinical care to participants. Data entry, 1 Pharmacist Dr. Ian Mwangi who will be responsible for the  application of import license for Investigational Products, IMP accountability from receipt to storage, cold chain maintenance, preparation and dispensing and accountability logs, and IMP destruction. Supervision of the Pharmaceutical Technologists at each of the study sites, and other 2 Pharm tech, 6 Nurses, 5 Quality Assurance/Quality Control Officers, 2 Clinical Officers, 7 Community Interviewers, 2 Data personnel and 3 Laboratory Personnel <span style=\"font-family: arial, helvetica, sans-serif;\">to conduct the clinical trials and offer medical care to research participants</span>.</p>\n
      • other_details_explanation<p>\n <span style=\"color: rgb(51, 62, 72); font-family: sans-serif; font-size: 16px; background-color: rgb(238, 238, 238);\">Forma Therapeutics, Inc. (Sponsor) is initiating Study 4202-HEM-202, titled, “A Single Arm,</span><br style=\"box-sizing: inherit; color: rgb(51, 62, 72); font-family: sans-serif; font-size: 16px;\" />\n <span style=\"color: rgb(51, 62, 72); font-family: sans-serif; font-size: 16px; background-color: rgb(238, 238, 238);\">Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease,” outside of the United States, specifically in Canada, UK, Lebanon, Nigeria, Turkey, and Kenya. Studies of etavopivat are ongoing in the United States (US) and globally where there is a consistent interest in etavopivat from sickle cell experts. Although 8 etavopivat clinical studies have been conducted or are currently being conducted in the US (2 of which include adolescent patients), US sites are not currently planned for Study 4202-HEM-202. There are several reasons for this, including that the sickle cell disease population in the US is rare, and sites have exhausted eligible patients with on-going Studies 4202-HEM-201 and 4202-HEM-301. The patient availability in the selected countries has the potential to provide improved therapy to children with sickle cell disease with significant unmet medical need. Depending on enrollment, the Sponsor may expand the conduct of the study to other countries including the US</span></p>\n
      • other_details_regulatory_notapproved<table class=\"table table-condensed\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; width: 917.271px; margin-bottom: 20px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <tbody>\n <tr>\n <td colspan=\"2\" style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221);\">\n <p style=\"margin: 0px 0px 10px;\">\n National Agency for Food & Drug Administration - Submitted 14Oct2022</p>\n <p style=\"margin: 0px 0px 10px;\">\n T.R. Ministry of Health Turkish Medicines and Medical Devices Agency - Submitted on 19 Sep 2022</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p 0px=\"\" font-size:=\"\" margin:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 16px;\">Health Canada (the Competent Authority in Canada) - Approved on 30Jun2022</span></p>\n<p 0px=\"\" font-size:=\"\" margin:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 16px;\">United Kingdom Regulatory Approval was received on 04Nov2022</span></p>\n<p 0px=\"\" font-size:=\"\" margin:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 16px;\">Healthcare Products Regulatory Agency approved on 04 Nov 2022</span></p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration100 Weeks
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
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      • design_controlled_parallel_group
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      • single_site_member_stateNo
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      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites4
      • multi_country_listNigeria, UK, Lebanon, Canada and Turkey
      • data_monitoring_committeeNo
      • total_enrolment_per_site4-6
      • total_participants_worldwide50
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
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      • investigator1_telephone+254733812613
      • investigator1_emailogutu@gmail.com
      • organisations_transferred_Yes
      • number_participants18
      • notification
      • approval_date19-07-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-06-2023
      • is_child0
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      • initial_date_submitted(null)
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      • approved2
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-20 17:43:13
      • created2023-06-12 12:34:13
      • total_sites(null)
      • ecitizen_invoice(null)
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        • given_nameWalter
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        • qualificationMD, Mmed
        • professional_addressUSAMRU-A/K PO Box 54, Kisumu
        • telephone+254 714481488
        • emailwalter.otiemo@usamru-k.org
        • created2023-06-13 10:23:38
        • modified2023-06-30 19:55:17
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        • application_id1280
        • given_nameVidelis
        • middle_name
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        • professional_addressKenya Medical Research Institute-Centre for Respiratory Disease Research P.O Box 47855-00100
        • telephone+254 724 522 474
        • emailvnduba@gmail.com
        • created2023-06-13 10:33:15
        • modified2023-06-30 19:55:17
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        • contact_details+254714481488
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        • created2023-06-13 10:23:38
        • modified2023-06-30 19:55:17
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • county_id42
        • site_nameKEMRI, Siaya Clinical Research Annex
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        • contact_details+254724522474
        • contact_personProf. Videlis Nduba
        • site_capacity(null)
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        • created2023-06-13 11:15:47
        • modified2023-06-30 19:55:17
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id670
        • application_id1280
        • sponsorForma Therapeutics, Inc
        • sponsor_typeIndustry
        • contact_person
        • address300 North Beacon Street, Suite 501 Watertown, MA 02472
        • telephone_number617-679-1970
        • fax_number
        • cell_number+1-857-209-2235
        • email_address4202-202Clinical@formarx.com
        • created2023-06-13 10:23:38
        • modified2023-06-30 19:55:17
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