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  • 1Recruiting
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• applications(array)
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    • 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
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      • 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
  • 1(array)
    • Application(array)
      • id1533
      • user_id820
      • trial_status_id(null)
      • abstract_of_study<p>\n Server Migration</p>\n
      • study_title<p>\n Server Migration</p>\n
      • laymans_summary<p>\n Server Migration</p>\n
      • short_titleServer migration
      • protocol_noECCT/25/04/07
      • version_no1
      • date_of_protocol29-04-2025
      • study_drugServer Migration
      • disease_conditionServer Migration
      • 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_nameServer Migration
      • product_type_medical_device_nameServer Migration
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjkiprotich@intellisoftkenya.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_applicantserver migration
      • declaration_date129-04-2025
      • declaration_principal_investigatorserver migration
      • declaration_date229-04-2025
      • placebo_presentNo
      • study_objectives<p>\n Server Migration</p>\n
      • principal_inclusion_criteria<p>\n Server Migration</p>\n
      • principal_exclusion_criteria<p>\n Server Migration</p>\n
      • primary_end_points<p>\n Server Migration</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Server Migration</p>\n
      • other_details_explanation<p>\n Server Migration</p>\n
      • other_details_regulatory_notapproved<p>\n Server Migration</p>\n
      • other_details_regulatory_approved<p>\n Server Migration</p>\n
      • other_details_regulatory_rejected<p>\n Server Migration</p>\n
      • other_details_regulatory_halted<p>\n Server Migration</p>\n
      • estimated_duration12
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorServer Migration
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaServer Migration
      • single_site_physical_addressServer Migration
      • single_site_contact_personServer Migration
      • single_site_telephoneServer Migration
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site500
      • total_participants_worldwide10000
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameServer Migration
      • investigator1_middle_name
      • investigator1_family_nameServer Migration
      • investigator1_qualificationServer Migration
      • investigator1_professional_addressServer Migration
      • investigator1_telephone0724743788
      • investigator1_emailjkiprotich@intellisoftkenya.co.ke
      • organisations_transferred_No
      • number_participants20
      • notification
      • approval_date30-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted29-04-2025
      • is_child0
      • unsubmitted1
      • initial_date_submitted29-04-2025
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonServer Migration
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-30 14:39:51
      • created2025-04-28 20:07:09
      • total_sites2
      • ecitizen_invoice368738
    • InvestigatorContact(array)
      • 0(array)
        • id1250
        • application_id1533
        • given_nameServer Migration
        • middle_name
        • family_nameServer Migration
        • qualificationServer Migration
        • professional_addressServer Migration
        • telephone0724743788
        • emailjkiprotich@intellisoftkenya.com
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
    • SiteDetail(array)
      • 0(array)
        • id1876
        • application_id1533
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id824
        • application_id1533
        • sponsorServer Migration
        • sponsor_typeResearch Institution
        • contact_personjapheth kiprotich
        • addressServer Migration
        • telephone_number0724743788
        • fax_number
        • cell_number0724743788
        • email_addressjkiprotich@intellisoftkenya.com
        • created2025-04-29 08:11:39
        • modified2025-04-30 14:38:27
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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