Request History

• Restore to current request
• applications/index/page:7/trial_therapeutic_confirmatory:1
• applications/index/trial_therapeutic_confirmatory:1/page:8

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1763045663
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page56
  • sortprotocol_no
  • directiondesc
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page56
    • current5
    • count524
    • prevPage(true)
    • nextPage(true)
    • pageCount105
    • order(array)
      • Application.protocol_nodesc
    • limit5
    • options(array)
      • page56
      • order(array)
        • Application.protocol_nodesc
      • sortprotocol_no
      • directiondesc
    • paramTypenamed

Post data

• Application(empty)

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id927
      • user_id559
      • trial_status_id7
      • abstract_of_study<p>\n The current World Health Organization (WHO) control strategy for Soil-Transmitted Helminths (STH) emphasizes morbidity control through mass drug administration with albendazole or mebendazole, mainly targeting pre-school and school-aged children in endemic areas. Increasing concerns have been raised about the success of these monotherapy strategies: 1) whilst albendazole is still efficacious against <em>Ascaris lumbricoides </em>and hookworm, a low and decreasing efficacy against <em>Trichuris trichiura </em>is observed, and none of these strategies is effective against <em>S. stercoralis</em>; 2) the use of widespread monotherapy could lead to the emergence of albendazole resistance. Modelling studies predict a huge impact on years lived with disability and economic productivity, if these strategies remain unchanged. Ivermectin has shown an enhanced activity against <em>T. trichiura </em>when combined with albendazole, and is considered the drug of choice against strongyloidiasis and other parasitic infections. Adding ivermectin to albendazole would increase efficacy of the interventions, and decrease the possibility of emergence of resistance, as recently suggested by WHO and the Bill and Melinda Gates Foundation reports.</p>\n<p>\n  </p>\n<p>\n The main goal of this project is to develop and test the safety and efficacy of a fixed-dose co-formulation of ivermectin and albendazole against STHs, as a single dose and a three-dose regimen, compared to a single dose of albendazole in a phase III clinical trial. The project will be conducted in schools in Kwale county along the shoreline of the Indian Ocean that has been shown to have high prevalence of <em>Trichiris trichiura</em>. The study population will be school aged children 5-15 years.</p>\n<p>\n  </p>\n<p>\n The project will include capacity building and networking activities. Besides microscopy-based procedures, parasite DNA detecting techniques (PCR) will be used and validated as markers of treatment response. Modelling studies will evaluate the potential impact on transmission and economic benefits of the new treatment regimen. The scientific results will be presented to the scientific community, local governments and other implementation actors and stakeholders. Previous collaborations of members of this consortium developed and tested the safety of a fixed high dose of ivermectin, as a first step towards the fixed- dose combination with albendazole. This consortium integrates complementary expertise in drug development, manufacture and expertise in drug development, manufacture and regulatory processes, expertise in parasitology, veterinary, epidemiology and public health.</p>\n
      • study_title<p align=\"center\">\n <strong>Evaluation of the effectiveness of IVERMECTIN co-formulation vs ALBENDAZOLE for treatment of </strong><strong>for the Treatment of Soil-Transmitted Helminth Infections (<em>Trichuris trichiura</em>, hookworm, <em>Strongyloides stercoralis</em>) in school aged children and Young Adult Subjects (ALIVE Study)</strong></p>\n
      • laymans_summary<p>\n <em>Lay title</em></p>\n<p>\n Evaluation of the effectiveness of IVERMECTIN co-formulation vs. ALBENDAZOLE for treatment of worms</p>\n<p>\n <em>Background</em></p>\n<p>\n Intestinal parasitic worm (STH) are common parasitic infections in Kenya, causing loss of blood and gastrointestinal problems and affecting how a child perfomes at school. The current World Health Organization (WHO) control strategy for worms emphasizes control of sickness cause by worms through mass deworming with albendazole or mebendazole, mainly  pre-school and school-aged children in areas where worms are found in Kenya. However, researchers have raised concerns about the success of these treatment of worms using single drugs as a low and ability of these drugs aganist against whipworms, and the possibilities that mass deworming could lead to the emergence of albendazole failure of the drugs to cure sicknes caused by the worms. Investigating the effectiveness of alternative drugs is important to ensure that these control mass deworming programmes are successful in achieving the target of controlling sickness causes by worms and eventually get rid of worminfection.</p>\n<p>\n <em>What questions are we trying to answer?</em></p>\n<p>\n We want to find out whether combining albendazole and ivermectin into a single drug will be more effective in treating of whipworm infection. The current drugs (albendazole and mebendazole) that are being used for the treatment of whipworm infections are not efficacious; therefore, many children remain infected. We also wish to find out if there is any resistance that can be identified to current deworming drugs that are being used.</p>\n<p>\n <em>Where is the study taking place, how many people does it involve and how are they selected?</em></p>\n<p>\n The study will take place in public primary schools whose village catchment areas are villages along the shores of the Indian Ocean in Kwale county. Approximately 800 children aged between 5-17 years attending one of the participating primary schools who have informed parental consent will be recruited into the study. Children will be selected to be part of the study based on willingness to be part of the research study and being infected with either hookworm, whipworm or threadworm.</p>\n<p>\n <em>What does the study involve for those who are taking part?</em></p>\n<p>\n At the beginning of the study, we will take a stool sample from the children to find out whether or not they are infected with worms. If children do not have worms or only have bilharzia, they will not be included in the study. Children who are infected with hookworm or whipworm or both will be recruited into the study. Once recruited, the children will be randomly assigned into one of the three study arms. Children will then be treated according to the treatment arm in which they were assigned. Twenty-one days after treatment, a stool sample will be collected to check for infection clearance. Study participants will be monitored by study doctors for 3h after treatment for adverse events that may have occurred as a result of treatment. Three and seven days after treatment, children will be revisited at the school premises for adverse event monitoring. In 100 childeren included in the first part of the study blood from a finger prick less than 1ml will be taken to conuct pharmacokinetics assessment at 4, 8, 24, 52 and 78 hours post treatment.</p>\n<p>\n <em>What are the risks and benefits involved in taking part?</em></p>\n<p>\n The drugs are known to show excellent safety profile except for those patients harbouring <em>Loa loa</em> infection(1). In recent studies, descriptions of little visual disturbance were observed. These events were reported to be mild, transient, and of short duration (a few minutes to a few hours). For this reason, in this study, subjects will be observed closely for any immediate risks after study drug administration. We do not think there will be any long-term effects on the participants. The use a combination of albendazole and ivermectin in the proposed combination therapy against STH could offer a solution to several disadvantages in the current strategy in terms of curing of whipworm infection. Participants may experience minor discomfort during the collection of finger-prick blood samples.</p>\n<p>\n <em>How will the study benefit society?</em></p>\n<p>\n The results from this study will offer insight for the effectiveness of a new combination of albendazole and ivermectin with great potential of improving the control of helminth worldwide, with emphasis on whipworms that are currently difficult to treat. Further this results, may increases the possibility of elimination of helminth with the possibility of a more effective drug. Millions of Africans living in areas where whipworm occurs may benefit.</p>\n<p>\n <em>When does the study start and finish?</em></p>\n<p>\n It is estimated that the study will take 18 months from recruitment (January 2021) until completion of data analyses (September 2022).</p>\n<p>\n  </p>\n
      • short_titleALIVE study
      • protocol_noECCT/20/08/02
      • version_noKenya Specific Protocol v1.7, 22nd May 2020
      • date_of_protocol06-08-2020
      • study_drugIVERMECTIN co-formulation vs. ALBENDAZOLE
      • disease_conditionSoil-Transmitted Helminth Infections
      • 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_nameIVERMECTIN co-formulation vs. ALBENDAZOLE
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameALBENDAZOLE
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressstellakepha2005@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_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantCharles Mwandawiro
      • declaration_date117-08-2020
      • declaration_principal_investigatorCharles Mwandawiro
      • declaration_date217-08-2020
      • placebo_presentNo
      • study_objectives<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width:312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width:312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;height:21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;height:21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Specific Phase II/Phase III</p>\n<ol>\n <li>\n Phase II: Positive infection test by microscopy for <em>T. trichiura</em></li>\n <li>\n Phase III: Positive infection test by microscopy for at least one of the following STH: <em>T. trichiura</em> hookworms, and/or larvae of <em>S. stercoralis</em>.</li>\n</ol>\n<p>\n To be applied to Phase II and Phase III</p>\n<ol>\n <li>\n Weight ≥15 Kg.</li>\n <li>\n Male or female, aged 5 to 18 years.</li>\n <li>\n Female subjects who are ≥12 years old must have a negative urine pregnancy test at screening or at the time of randomization.</li>\n <li>\n Ability to take oral medication, willingness to comply with all study procedures.</li>\n <li>\n Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. Verbal assent will also be obtained from children aged 12–18 years.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Intake of ALB, mebendazole and/or IVM or any potentially interacting drug three months prior to the time of randomisation within the previous 3 months before screening.</li>\n <li>\n Residence outside the study area or planning to move away in the four weeks following recruitment.</li>\n <li>\n Epidemiological risk of <em>Loa loa</em> infection.</li>\n <li>\n Serious medical illness, per investigator’s criteria.</li>\n <li>\n Any participant’s condition preventing from the appropriate evaluation and follow-up, as per investigator’s criteria.</li>\n <li>\n Known hypersensitivity to any component of either study treatment.</li>\n <li>\n Positive urine test, pregnant or first week post-partum.</li>\n</ol>\n
      • primary_end_points<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width: 312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width: 312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px; height: 21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px; height: 21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n This study will be conducted in primary and secondary schools in Ethiopia, Kenya and Mozambique.</p>\n<p>\n Kenya (phase II and III components)</p>\n<p>\n The study will take place in Kwale county situated on the South coast of Kenya. It borders Tanzania to the South west, Taita taveta County to the West. The total area of the county is approximately 8,270 Km2 with a population of about 760,897.  The southern region of the county is on the shoreline of the Indian Ocean. The county is divided into four sub-counties, twenty wards (and thirty-four (34) locations. The county has 357 public primary schools (class 1-8). Stool and urine sample will be processed at the KEMR-Kwale laboratory.</p>\n<p>\n Ethiopia (phase III component only)</p>\n<p>\n The study will be conducted in the Bahir Dar Zurya woreda (district) in the West Gojam zone of the Amhara region which has an area of 1,443.37 Km2, and a population of 230,000. The district has 36 primary (grade 1 to 8) and 6 secondary (grade 9 and 10) schools. The total number of student population is 49,013 with an average of 1,160 students in each school. Stool and urine samples will be processed at the BDU laboratory by competent laboratory technicians.</p>\n<p>\n Mozambique (phase III component only)</p>\n<p>\n The study will be conducted in the Manhiça district in Southern Mozambique, a peri-urban setting with a predominantly young population. The site runs a Demographic Surveillance System in the area which covers the entire district, with a population of ≈204,000 inhabitants under surveillance, 44% of which are <15 years of age. Every household from the study area is geo-localised with an identification number.  The district has 93 primary and 9 secondary schools with a total student population of 72,829. Stool and urine samples will be processed at the FM-CISM laboratory by competent laboratory technicians.</p>\n<p>\n  </p>\n<p>\n At all sites, community sensitization will be conducted in the villages where the school children live by community health workers. Only children with informed consent and assent will be screened for eligibility and those who are eligible will be enrolled into the study</p>\n
      • other_details_explanation<p>\n The STOP the consortium is coordinated by the <strong>Barcelona Institute for Global Health (ISGlobal)</strong>, in Spain. The institute has greatly contributed to the translation of health research into public health policies, specially, in the fields of NTDs such as Chagas and Yaws disease as well as in Malaria. ISGlobal will coordinate the execution of the Clinical Trial in three sub-Saharan research centres:</p>\n<p>\n 1) The <strong>Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) </strong>has an excellence track record conducting clinical trials with high international standards, and has strong international partnerships, including with the EDCTP Network of Excellence TESA (Trials of Excellence in Southern Africa). Moreover, CISM has a state-of-the-art molecular biology laboratory and the WP5 leader has extensive experience with the performance of molecular diagnostics.</p>\n<p>\n 2) <strong>Bahir Dar University (Ethiopia) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa.</p>\n<p>\n 3) <strong>Kenyan Medical Research Institute (KEMRI) </strong>is one of the leading institutions in sub-Saharan Africa conducting integrated epidemiological, social, laboratory and clinical research in parallel, with results feeding into local and international health policy. The research facilities in KEMRI include state-of-the-art laboratories, including molecular biology expertise.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n 1) The Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) review Board, submitted awaiting feedback</p>\n<p>\n 2) Bahir Dar University (Ethiopia<strong>) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa<strong> s</strong>ubmitted awaiting feedbacl</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRegistered Albendazole
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKwale
      • single_site_physical_addressMsambweni, Lunga Lunga
      • single_site_contact_personStella kepha
      • single_site_telephone0721 831303
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listEthiopia and Mozambique
      • data_monitoring_committeeYes
      • total_enrolment_per_site527
      • total_participants_worldwide1223
      • 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_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStella
      • investigator1_middle_name
      • investigator1_family_nameKepha
      • investigator1_qualificationPhD
      • investigator1_professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
      • investigator1_telephone+254-20-2722541
      • investigator1_emailstellakepha2005@yahoo.com
      • organisations_transferred_Yes
      • number_participants126 in Phase II\n401 Phase III\n
      • notification<p>\n N/A</p>\n
      • approval_date12-01-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">Among 1001 </span><span style=\"outline: none !important;\">participants, 636 (63·5%) were infected with </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, 360 (36·0%) with hookworm, and 104 (10·4%) with </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span><span style=\"outline: none !important;\">. A total of 243 </span>participants were allocated to the ALB arm, 381 to the FDCx1, and 377 to the</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">FDCx3· In both Phase II and III, gastrointestinal symptoms were the most common </span>mild-to-moderate adverse events (AEs) in FDC groups, being resolved within 48 <span style=\"outline: none !important;\">hours without intervention. No serious AEs occurred. For </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, FDCx3 and FDCx1 showed higher CR (97·2% and 82·9%, </span>respectively) than ALB (35·9%). For hookworms, FDCx3 showed a superior CR (95·0%)</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">than ALB (65·1%), while FDCx1 had a similar CR (79·8%) to ALB. The sample size </span><span style=\"outline: none !important;\">for efficacy evaluation of </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span></p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">was not met.</span></p>\n
      • implication_results<div>\n This Phase II/III study met its primary objectives of demonstrating safety (Phase II) and efficacy (Phase III) of FDC in the enrolled pediatric populations:</div>\n<div>\n ï‚· FDC is more effective for curing T. trichiura infections than ALB, as shown by the significantly higher CRs compared with ALB, and supported by the secondary efficacy endpoint result of significantly higher T. trichiura ERRs compared with ALB.</div>\n<div>\n ï‚· Both of the FDC administration schedules are considered viable dosing strategies, as shown by significantly higher T. trichiura CRs with both the FDC Single Dose and FDC x3 compared with ALB.</div>\n<div>\n ï‚· FDC x3 is more effective for curing hookworm infection than ALB.</div>\n<div>\n ï‚· The efficacy of FDC for curing S. stercoralis was considered inconclusive due to the small sample size of participants positive for this STH.</div>\n<div>\n ï‚· Results of the PPK analysis indicate that the FDC single dose and FDC x3 dosing regimens are adequate for participants over or under 30 kg.</div>\n<div>\n ï‚· FDC single dose and FDC x3 are safe in pediatric populations, as shown by no serious TEAEs and only mild or moderate TEAEs.</div>\n
      • quantity_imported3400
      • quantity_dispensed1116
      • quantity_destroyed2284
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2024-03-25 17:10:18
      • created2020-08-06 14:15:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id573
        • application_id927
        • given_nameCharles
        • middle_name
        • family_nameMwandawiro
        • qualificationPhD
        • professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
        • telephone+254-20-2722541
        • emailcmwandawiro@kemri.org
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
    • SiteDetail(array)
      • 0(array)
        • id802
        • application_id927
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id447
        • application_id927
        • sponsorBARCELONA INSTITUTE FOR GLOBAL HEALTH FOUNDATION
        • sponsor_typeResearch Institution
        • contact_personDr. Nana Aba Williams
        • addressBarcelona (08036), Rosselló, 132
        • telephone_number0034 932275400
        • fax_number
        • cell_number0034 932275400
        • email_addressnana.williams@isglobal.org
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
  • 1(array)
    • Application(array)
      • id914
      • user_id636
      • trial_status_id5
      • abstract_of_study<p style=\"direction: ltr; \">\n First in human study to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Feefteen subjects will be enrolled after screening by the participating clinical sites’ clinical team (physician and study staff) during a screening visit. Each subject will sign the ICF prior to any study activities and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr;\">\n  </p>\n
      • study_title<p dir=\"ltr\">\n <strong>The CorNeat EverPatch – A First-In-Human Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts</strong></p>\n<p>\n  </p>\n
      • laymans_summary<p style=\"direction: ltr; \">\n This is a First in human study aimed to demonstrate the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts.</p>\n<p style=\"direction: ltr;\">\n Each subject will sign an informed consent form prior to any study activities. Subjects will be screened by the participating clinical sites’ clinical team (physician and study staff) during a screening visit and will be evaluated for inclusion and exclusion criteria. Only eligible subjects will be enrolled.</p>\n<p style=\"direction: ltr;\">\n Demographic data, medical history and concomitant medication use data will be collected from enrolled subjects. Subjects will be implanted with the CorNeat EverPatch and followed-up for ocular wall integrity at the implantation site (primary endpoint) and stability in patch dimensions - less than 10% change (length, projected width and thickness) measured by OCT on 6 months and 12 months. 9 clinic visits will be required: Screening, Implantation and 7 follow up visits. During follow-up visits safety data and use of concomitant medications will be documented. Subjects successfully completing 12 months of follow-up will be monitored for device retention and local tissue reaction every 6 months by a comprehensive ophthalmologist’s exam.</p>\n<p style=\"direction: ltr;\">\n Follow-up plan will include complete clinical exam and anterior segment OCT examining the EverPatch and measuring its dimensions. An alternative to OCT is Ultra Sound Bio-Microscopy (UBM)- high frequency US.</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • short_titleCorNeat EverPatch
      • protocol_noECCT/20/08/01
      • version_no7.2
      • date_of_protocol11-06-2020
      • study_drugCorNeat EverPatch
      • disease_conditionConcealment of artificial implants and glaucoma tube shunts
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_namePermanent ophthalmic implant
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressido@corneat.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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantGerry Tal
      • declaration_date103-08-2020
      • declaration_principal_investigatorLily Nyamai
      • declaration_date203-08-2020
      • placebo_presentNo
      • study_objectives<p style=\"direction: ltr; \">\n This clinical trial will assess the safety of the CorNeat EverPatch device</p>\n
      • principal_inclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Male or female</li>\n <li style=\"direction: ltr; text-align: left;\">\n Aged ≥ 18 and ≤ 80 years on screening day</li>\n <li style=\"direction: ltr; text-align: left;\">\n Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Candidates must have the ability and willingness to attend all scheduled visits and   comply with all study procedures</li>\n <li style=\"direction: ltr; text-align: left;\">\n Adequate tear film and lid function </li>\n <li style=\"direction: ltr; text-align: left;\">\n Visual acuity of light perception or better</li>\n <li style=\"direction: ltr; text-align: left;\">\n Female patients of childbearing age must agree to use a method of contraception and have negative pregnancy test at screening. An effective method of contraception must be used throughout the study.</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li style=\"direction: ltr; text-align: left;\">\n Current retinal detachment</li>\n <li style=\"direction: ltr; text-align: left;\">\n Active ocular or orbital infection</li>\n <li style=\"direction: ltr; text-align: left;\">\n History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of ocular or periocular malignancy</li>\n <li style=\"direction: ltr; text-align: left;\">\n History of extensive keloid formation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or         component of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Signs of current infection, including fever and current treatment with antibiotics</li>\n <li style=\"direction: ltr; text-align: left;\">\n Severe generalized disease that results in a life expectancy shorter than a year</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Currently pregnant or breastfeeding</li>\n <li style=\"direction: ltr; text-align: left;\">\n Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device</li>\n <li style=\"direction: ltr; text-align: left;\">\n Intraoperative complication that would preclude implantation of the study device.</li>\n <li style=\"direction: ltr; text-align: left;\">\n Any traumatic perforation</li>\n <li style=\"direction: ltr; text-align: left;\">\n Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage</li>\n <li style=\"direction: ltr; text-align: left;\">\n Loss of scleral integrity where use of tissue or substitutes is indicated</li>\n</ol>\n<p style=\"direction: ltr; \">\n  </p>\n
      • primary_end_points<p style=\"direction: ltr;\">\n Primary Safety Endpoint:</p>\n<p style=\"direction: ltr;\">\n The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, and follow-up for up to 12 months will be 10% or less.</p>\n<p style=\"direction: ltr;\">\n Effectiveness Endpoints:</p>\n<p style=\"direction: ltr;\">\n Primary: Conjunctival integrity at the implantation site will be 90% or more.</p>\n<p style=\"direction: ltr;\">\n Secondary: Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p dir=\"RTL\" style=\"direction: ltr; margin-right: 5.4pt;\">\n The proposed sites can ensure patient safety as they are centers of excellence. The centers are all well equipped to manage glaucoma cases and any complication if they occur; they all have well-equipped clinics, OR (operating room), pharmacies and lasers used in glaucoma (YAG, SLT). The PI will conduct enrollment, surgeries and follow-up in both centers. There is room for cross referral across disciplines in all centers.</p>\n<p style=\"direction: ltr;\">\n Additionally, EverPatch device replaces the use of artificial / tissue-based patches and does not require any specific change in the implantation procedure. Dr. Nyamai has successfully completed the Sponsor’s training during which the necessary information pertaining the specific protocol, the investigational product, data collection procedures and safety management was provided. This training was set to ensure that the clinical study will be conducted in accordance with the study protocol and Good Clinical Practice principles.</p>\n<p style=\"direction: ltr;\">\n <u>Description of Study Sites in Kenya:</u></p>\n<ol>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>Lions SightFirst Hospital</strong> -  is the largest eye hospital in Kenya. It is well equipped with subspecialty clinics, operating room (OR), diagnostic equipment (OCT and visual fields), pharmacies and lasers used in glaucoma (Argon, YAG). The glaucoma patients at the Lions SightFirst hospital are currently followed up by general ophthalmologists and clinical officers.  These ophthalmologists get referrals from outreach activities and other subspecialty clinics (cornea and retina). The clinic has an average of 20- 30 glaucoma patients visiting per week with 7-10 glaucoma surgeries performed per week. The PI will carry out a glaucoma clinic on two clinic days and one operating day for purposes of the study.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kenyatta National Hospital</strong> – is the oldest and largest hospital in the country. The PI also runs a general ophthalmology clinic in the KNH COC, with an average of 5 patients a month with a diagnosis of glaucoma. As the clinic in COC is relatively new and first line treatment for glaucoma is eye drops, only about 1 patient a month or less requires an Ahmed Glaucoma Valve (AGV) insertion. Ophthalmologists from the specialist clinics from the general eye clinic in the hospital will also be engaged by referring cases for AGV insertion.</li>\n <li style=\"direction: ltr; text-align: left;\">\n <strong>The Kwale Eye institute</strong> - is a well-equipped center with clinics, OR, diagnostic equipment (OCT and visual fields) pharmacy, wet-lab and lasers used in glaucoma (SLT, YAG & Argon). The Kwale Eye Center has about 20 glaucoma patients per week seen at the general ophthalmology clinic. Glaucoma surgeries performed are about 3 per week. The PI will carry out clinic and OR for purposes of the study as deemed necessary.</li>\n</ol>\n<p style=\"direction: ltr;\">\n The PI assists with outreach activities at the Kwale Eye Center and was trained in cataract surgery and general ophthalmology in this center during her elective term as a resident in ophthalmology under the mentorship of Dr. Helen Roberts, a general ophthalmologist  and medical director of the hospital</p>\n<p style=\"direction: ltr;\">\n Kwale Eye Institute has conducted a clinical study on SLT laser in glaucoma among African eyes and was able to conclude the effectiveness of SLT laser in an African population; in addition, they acquired an SLT laser machine for the center through the study. The Kwale and Lions Sight first Eye centers have also been active in clinical research through residents in ophthalmology attending elective terms there, carrying out research for their dissertation.</p>\n<p style=\"direction: ltr;\">\n  </p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_explanation<p style=\"direction: ltr; \">\n Clinical sites have been chosen according to future markets planned for the devices</p>\n
      • other_details_regulatory_notapproved<p style=\"direction: ltr; \">\n ANSM - French National Agency for Medicines and Health Products Safety - Submitted on April 12th, 2020</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_approved<p style=\"direction: ltr; \">\n Health Canada (Canada) - approved on December 16th, 2019; Two sites in Canada</p>\n<p style=\"direction: ltr; \">\n  </p>\n
      • other_details_regulatory_rejected<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • other_details_regulatory_halted<p style=\"direction: ltr; \">\n Not Applicable</p>\n
      • estimated_duration3 months recruitment + 12 months follow up = up to 15 months
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorHistorical Data
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites3
      • multi_country_listCanada, France, Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_siteLions SightFirst hospital will recruit 8 participants for the study, KNH (Kenyatta National Hospital) will recruit 2 participants and The Kwale center will recruit 5 participants
      • total_participants_worldwide40
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLily
      • investigator1_middle_nameAdhiambo
      • investigator1_family_nameNyamai
      • investigator1_qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
      • investigator1_professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
      • investigator1_telephone+254721710027
      • investigator1_emaillilynyamai@gmail.com
      • organisations_transferred_No
      • number_participants15
      • notification
      • approval_date10-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication approved by the expert committee
      • final_report<p>\n <strong>Introduction:</strong> This executive summary presents the key findings from the CorNeat EverPatch FIH clinical trial, conducted at two clinical sites in Kenya: Lions SightFirst Hospital in Nairobi and Kwale Eye Center in Mombasa. The trial aimed to evaluate the safety and efficacy of the CorNeat EverPatch, a novel medical device for ocular applications.</p>\n<p>\n <strong>Clinical Site: Lions SightFirst Hospital – Nairobi, Kenya:</strong></p>\n<p>\n Of the 8 implanted patients, 4 patients successfully completed the 12-month follow-up without noteworthy device-related complications. It's important to note that a unique surgical technique was employed, with sutures placed on top of the implanted patch, which may have affected the outcomes due to potential migration and increased susceptibility to breakdown.</p>\n<p>\n A single patient experienced patch exposure and complications leading to implant removal, primarily due to recurrent conjunctival erosion and infection. Another patient had patch exposure, leading to implant removal and replacement with another CorNeat EverPatch. No significant damage to ocular structures was noted in either case.</p>\n<p>\n Two additional patients exhibited recurring patch exposure, which resolved without surgical intervention. No other abnormalities were observed.</p>\n<p>\n <strong>Clinical Site: Kwale Eye Center – Mombasa, Kenya:</strong></p>\n<p>\n Five patients were enrolled to the trial out of which, 2 patients completed the follow-up period without any adverse reactions, indicating the safety of the CorNeat EverPatch in these cases.</p>\n<p>\n A single patient experienced a large conjunctival defect and patch exposure at 2 months post-op, which recurred after a failed attempt to close the gap with sutures. At 9 months post-op, the patch was surgically removed, replaced with a scleral patch, and covered with conjunctiva graft. No infection or adverse reactions to ocular tissues were observed.</p>\n<p>\n The trial excluded the two remaining patients, with one being lost to follow-up, and the other passing away during the trial from natural causes unrelated to the device or the procedure.</p>\n<p>\n  </p>\n
      • implication_results<p>\n The CorNeat EverPatch FIH clinical trial in Kenya has yielded mixed results. While some patients experienced successful implantation without complications, others faced patch exposure and device-related complications, leading to explantation. The unique surgical technique employed may have influenced outcomes. Further evaluation and refinement of the device and surgical approach are warranted to enhance the safety and efficacy profile. These findings will contribute valuable insights for the ongoing development and regulatory evaluation of the CorNeat EverPatch in Kenya.</p>\n<p>\n  </p>\n
      • quantity_imported20
      • quantity_dispensed20
      • quantity_destroyed6
      • quantity_exportedNA
      • balance_site0
      • final_date0000-00-00
      • modified2023-09-06 10:47:39
      • created2020-06-23 08:29:27
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id565
        • application_id914
        • given_nameLily
        • middle_nameAdhiambo
        • family_nameNyamai
        • qualificationCertified Ophthalmologist MBChB, MMed Ophth, FCOECSA, Fellowship Glaucoma
        • professional_addressUniversity of Nairobi, P.O. BOX 19676, Nairobi, Kenya
        • telephone+254721710027
        • emaillilynyamai@gmail.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
    • SiteDetail(array)
      • 0(array)
        • id787
        • application_id914
        • county_id47
        • site_nameLions SightFirst Hospital
        • physical_addressKaptagat Rd, Nairobi, Kenya
        • contact_details+254721710027
        • contact_personDr. Lily Nyami
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id788
        • application_id914
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressHospital Rd, Nairobi, Kenya
        • contact_details+254722766233
        • contact_personDr. Owen Ogony
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id789
        • application_id914
        • county_id2
        • site_nameKwale Eye Centre
        • physical_addressLikoni-Ukunda Rd, Mombasa, Kenya
        • contact_details+25472220287
        • contact_personDr. Helen Roberts
        • site_capacity(null)
        • misc(null)
        • created2020-06-23 09:49:09
        • modified2020-08-05 16:05:31
        • County(array)
          • id2
          • county_nameKwale
          • created2012-05-31 16:15:21
          • modified2012-05-31 16:15:21
    • Sponsor(array)
      • 0(array)
        • id439
        • application_id914
        • sponsorCorNeat Vision
        • sponsor_typeIndustry
        • contact_personGerry Tal
        • addressHasheizaf 4, st Raanana, Israel
        • telephone_numberNA
        • fax_number
        • cell_number+972 52-356-2826
        • email_addressgerry@corneat.com
        • created2020-06-23 09:37:41
        • modified2020-08-05 16:05:31
  • 2(array)
    • Application(array)
      • id886
      • user_id659
      • trial_status_id(null)
      • abstract_of_study<p>\n Pre-clinical data have established P-selectin as a key mediator of vaso-occlusion in SCD and suggest that its blockade could eliminate or reduce VOCs</p>\n<p>\n The A2210 study (SUSTAIN) compared  the mean trough percentage P-selectin inhibition obtained with crizanlizumab following administration of 2.5mg/kg dose and 5.0mg/kg dose and suggested that the degree of clinical benefit may be correlated with achieving a certain level of P-selectin inhibition.</p>\n<p>\n Since trough concentration is highly correlated with % P-selectin inhibition 7.5mg/kg is the proposed dose to achieve higher percentage P-selectin inhibition in SCD patients</p>\n<p>\n The purpose of this study is to compare the efficacy and safety of two doses of crizanlizumab 5mg/kg and 7.5mg/kg verses placebo in adolescent and adult SCD patients with history of VOC leading to healthcare visit</p>\n
      • study_title<p>\n A Phase III multicenter, randomized, double blind study to assess efficacy and safety of two doses of crizanlizumab verses placebo, with or without hydroxyurea/hydroxycarbamide therapy in adolescent and adult sickle cell disease patients with Vaso-Occlusive Crises (STAND)</p>\n
      • laymans_summary<p>\n A study of two doses of crizanlizumab versus placebo in adolescent and adult sickle cell disease patients with vaso-occlusive crises</p>\n
      • short_titleSTAND
      • protocol_noECCT/20/07/03
      • version_no2
      • date_of_protocol02-06-2020
      • study_drugCrizanlizumab
      • disease_conditionSickle Cell Disease
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssarah.muthuri@novartis.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantSarah Muthuri
      • declaration_date131-07-2020
      • declaration_principal_investigatorProf Bernard Oguti
      • declaration_date231-07-2020
      • placebo_presentYes
      • study_objectives<p>\n Primary Objective: • To compare the efficacy of 7.5 mg/kg of crizanlizumab versus placebo on the annualized rate of VOC leading to healthcare visit, in addition to standard of care • To compare the efficacy of 5.0 mg/kg of crizanlizumab versus placebo on the annualized rate of VOC leading to healthcare visit, in addition to standard of care Secondary Objective •To assess the time to first and second VOC leading to healthcare visit in each group •To assess rate of subjects free from VOC leading to healthcare visit in each group •To assess the number of days with VOC leading to healthcare visit in each group •Healthcare resource utilization (visits to clinic, Emergency room (ER) and hospitalizations) in each group •To assess SCD-related renal damage in each group •To characterize the pharmacokinetic (PK) profile of crizanlizumab at 5.0 and 7.5 mg/kg •To characterize the pharmacodynamic (PD) (P-selectin inhibition) of crizanlizumab at 5.0 and 7.5 mg/kg •To assess efficacy, safety and immunogenicity of crizanlizumab over the study period (taking into account potential treatment switch after primary analysis)</p>\n
      • principal_inclusion_criteria<p>\n 1.Written informed consent must be obtained prior to any screening procedures 2.Male or female patients aged 12 years and older on the day of signing informed consent. Adolescent include patients aged 12 to 17 years old and adults ≥ 18 years and older 3.Confirmed diagnosis of SCD by Hb electrophoresis or high performance liquid chromatography (HPLC) (performed locally). All SCD genotypes are eligible, genotyping is not required for study entry 4.Experienced at least 2 VOCs leading to healthcare visit within the 12 months prior to screening visit as determined by medical history. Prior VOC leading to healthcare visit must include: a.Pain crisis defined as an acute onset of pain for which there is no other medically determined explanation other than vaso- occlusion b.a visit to a medical facility and/or healthcare professional, c.and receipt of oral/parenteral opioids or parenteral nonsteroidal anti- inflammatory drug (NSAID) analgesia As well as other complicated crises, such as ACS, priapism, and hepatic or splenic sequestration 5.If receiving HU/HC or erythropoietin stimulating agent or L-glutamine, must have been receiving the drug for at least 6 months prior to Screening visit and plan to continue taking at the same dose and schedule until the subject has reached one year of study treatment 6.Patients must meet the following central laboratory values at the screening visit: •Absolute Neutrophil Count ≥1.0 x 109/L •Platelet count ≥75 x 109/L •Hemoglobin: for adults (Hb) ≥4.0 g/dL and for adolescents (Hb) ≥5.5 g/dL •Glomerular filtration rate ≥ 45 mL/min/1.73 m2 using CKD-EPI formula in adults, and Schwartz formula in adolescents •Direct (conjugated) bilirubin < 2.0 x ULN •Alanine transaminase (ALT) < 3.0 x ULN 7.ECOG performance status ≤2.0 for adults and Karnofsky ≥ 50% for adolescents</p>\n
      • principal_exclusion_criteria<p>\n 1.History of stem cell transplant. 2.Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted. 3.Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction. 4.Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to Screening visit or plans to participate in another investigational drug trial. 5.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception during dosing and for 15 weeks after stopping treatment. 6.Concurrent severe and/or uncontrolled medical conditions which, in the opinion of the Investigator, could cause unacceptable safety risks or compromise participation in the study. 7.History or current diagnosis of ECG abnormalities indicating significant risk of safety such as: •Resting QTcF ≥470 msec at pretreatment (baseline) for both male and female or instability to determine QTc •Concomitant clinically significant cardiac arrhythmias (e.g ventricular tachycardia), and clinically significant second or third degree AV block without a pacemaker •History of familial long QT syndrome or know family history of Torsades de Pointes 8.Not able to understand and to comply with study instructions and requirements.</p>\n
      • primary_end_points<p>\n The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult SCD patients with history of VOC leading to healthcare visit. Phase 3, randomized, placebo-controlled, double-blind study comparing 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in addition to standard of care that subjects might be taking at the time of study start in adolescent and adult SCD patients with history of VOC leading to healthcare visit.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic1
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyBiomarker, Adult Sickle cell quality of Life measurement system short forms (ASCQ-MeSF) and Sickle cell pain Diary self report (SCPD-S)
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n These are included in the checklist</p>\n
      • other_details_explanation<p>\n The host country has focussed on the paediatric CSEG101B2201 Study.They expect a low protocol compliance of the population</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <tbody>\n <tr>\n <td>\n Country</td>\n <td>\n HA approval date</td>\n <td>\n No of sites</td>\n </tr>\n <tr>\n <td>\n Belgium</td>\n <td>\n 7 Jun 2019</td>\n <td>\n 5</td>\n </tr>\n <tr>\n <td>\n Brazil</td>\n <td>\n 21 Jun 2019</td>\n <td>\n 9</td>\n </tr>\n <tr>\n <td>\n Canada</td>\n <td>\n 29 May 2019</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Colombia</td>\n <td>\n 18 Dec 2019</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n Egypt</td>\n <td>\n Pending</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Finland</td>\n <td>\n 12 Jul 2019</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n France</td>\n <td>\n 17 Jun 2019</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Germany</td>\n <td>\n 8 Jul 2019</td>\n <td>\n 5</td>\n </tr>\n <tr>\n <td>\n Ghana</td>\n <td>\n 16 Mar 2020</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Greece</td>\n <td>\n 8 Jul 2019</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n India</td>\n <td>\n 4 Jul 2019</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n Italy</td>\n <td>\n 5 Jul 2019</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n Jordan</td>\n <td>\n 31 Jul 2019</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Lebanon</td>\n <td>\n 5 Jul 2019</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Netherlands</td>\n <td>\n 23 Apr 2019</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Oman</td>\n <td>\n NA EC only</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Panama</td>\n <td>\n NA EC only</td>\n <td>\n 3</td>\n </tr>\n <tr>\n <td>\n Saudi Arabia</td>\n <td>\n Submission under preparation</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n South Africa</td>\n <td>\n 24 Jul 2019</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n Spain</td>\n <td>\n 22 Oct 2019</td>\n <td>\n 4</td>\n </tr>\n <tr>\n <td>\n Turkey</td>\n <td>\n 16 Oct 2019</td>\n <td>\n 2</td>\n </tr>\n <tr>\n <td>\n UAE</td>\n <td>\n 29 Oct 2019</td>\n <td>\n 1</td>\n </tr>\n <tr>\n <td>\n UK</td>\n <td>\n 16 May 2019</td>\n <td>\n 6</td>\n </tr>\n <tr>\n <td>\n USA</td>\n <td>\n Submitted 6 Mar 2019</td>\n <td>\n 9</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • 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_states24
      • number_of_sites3
      • multi_country_listBelgium Brazil Canada Colombia Egypt Finland France Germany Ghana Greece India Italy Jordan Lebanon Netherlands Oman Panama Saudi Arabia South Africa Spain Turkey UAE UK USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site7
      • total_participants_worldwide240
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_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_othersYes
      • subjects_others_specifyAdolescent Sickle cell patients Older than 12 years
      • investigator1_given_nameBernhards
      • investigator1_middle_nameRagama
      • investigator1_family_nameOgutu
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressOle Sangale Road, P O Box 59857 00200 Nairobi
      • investigator1_telephone254733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants21
      • notification<p>\n No</p>\n
      • approval_date30-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication has been approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-09-01 18:31:04
      • created2020-05-08 11:45:30
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id547
        • application_id886
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMedical Doctor
        • professional_addressOle Sangale Road, P O Box 59857 00200 Nairobi
        • telephone254733812613
        • emailogutu6@gmail.com
        • created2020-05-12 10:21:57
        • modified2020-07-31 20:20:55
    • SiteDetail(array)
      • 0(array)
        • id769
        • application_id886
        • county_id47
        • site_name CREATES Strathmore University
        • physical_addressOle Sangale Road, Madaraka
        • contact_detailsP O Box 59857 00200
        • contact_personDr Bernard Oguttu
        • site_capacity(null)
        • misc(null)
        • created2020-05-12 10:21:57
        • modified2020-07-31 20:20:55
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id791
        • application_id886
        • county_id47
        • site_nameGetrudes Childrens Hospital
        • physical_address34 Muthaiga road
        • contact_detailsP O Box 763474 00100
        • contact_personDr Doreen Mutua
        • site_capacity(null)
        • misc(null)
        • created2020-06-30 12:28:54
        • modified2020-07-31 20:20:55
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id792
        • application_id886
        • county_id28
        • site_nameInternational Cancer Institute
        • physical_addressNandi Road Block 8 102
        • contact_detailsP O Box 8088 30100
        • contact_personDr Fredrick Chite
        • site_capacity(null)
        • misc(null)
        • created2020-06-30 12:28:54
        • modified2020-07-31 20:20:55
        • County(array)
          • id28
          • county_nameElgeyo/Marakwet
          • created2012-06-15 10:25:27
          • modified2012-06-15 10:25:27
    • Sponsor(array)
      • 0(array)
        • id430
        • application_id886
        • sponsorNovartis Pharma AG
        • sponsor_typeIndustry
        • contact_personSarah Muthuri
        • addressP O Box 46057 00100 GPO
        • telephone_number254 20 245 9112
        • fax_number
        • cell_number254 722706941
        • email_addresssarah.muthuri@novartis.com
        • created2020-05-12 10:21:57
        • modified2020-07-31 20:20:55
  • 3(array)
    • Application(array)
      • id923
      • user_id613
      • trial_status_id7
      • abstract_of_study<div>\n A safe and effective HIV vaccine would be the cornerstone for cost-effective, user-independent</div>\n<div>\n prevention methods against HIV infection. Most of the successfully licensed vaccines for</div>\n<div>\n prevention of infections have historically relied upon aluminum salt (alum) formulations as</div>\n<div>\n adjuvants because they generally improve protective antibody magnitudes over the vaccine antigen</div>\n<div>\n alone and are reliably safe.</div>\n<div>\n Antibodies are the most commonly recognized correlate of vaccine protection from infection;</div>\n<div>\n however, the possible protective HIV antibody levels, which were induced by the modestly</div>\n<div>\n protective RV144 vaccine regimen with alum, rapidly decayed. Potentially, a novel, highly</div>\n<div>\n selective adjuvant combined with the correctly sequenced HIV antigen could slow antibody decay,</div>\n<div>\n increase antibody magnitude, and induce antibodies of appropriate functional response.</div>\n<div>\n RV460 is an exploratory study that will assess the safety, tolerability, and immunogenicity of a</div>\n<div>\n vaccine regimen consisting of priming with an Env-C Plasmid DNA vaccine (with or without</div>\n<div>\n novel adjuvants) when given with or without adjuvanted HIV Env gp145 C.6980 protein vaccine</div>\n<div>\n and boosting with adjuvanted gp145 C.6980 protein with or without the gp120 DNA vaccine. The</div>\n<div>\n study will be carried out at the KEMRI/US Army Medical Research Directorate-Africa</div>\n<div>\n (USAMRD-A), Clinical Research Centre, Kericho; and 126 healthy adults will be enrolled.</div>\n<div>\n Participants enroll randomly into one of seven groups which have 15/3 vaccine/placebo recipients</div>\n<div>\n per group. Each participant will receive six injections (prime at week 0, 4, 12; boost at week 20,</div>\n<div>\n 32 and 56) followed up for a total of 108 weeks.</div>\n<div>\n Study objectives will be met by the testing of blood samples from all participants. Willing and</div>\n<div>\n eligible participants have the option to provide lymph node and mucosal secretion samples (semen,</div>\n<div>\n cervicovaginal, rectal), which will provide the data for objectives 2 and the sub-objections.</div>\n<div>\n Exploratory objectives may be met by genetic analysis including but not limited to Human</div>\n<div>\n Leukocyte Antigen (HLA) subtyping.</div>\n
      • study_title<div>\n A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of</div>\n<div>\n Priming with Env-C Plasmid DNA Vaccine Alone, with Different Adjuvants, or with an</div>\n<div>\n Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting with the Adjuvanted</div>\n<div>\n HIV Env gp145 C.6980 Protein Vaccine with or without the Env-C Plasmid DNA Vaccine</div>\n<div>\n in Healthy HIV Uninfected Adults in Kenya</div>\n
      • laymans_summary<div>\n The Kenya Medical Research Institute (KEMRI) in collaboration with the U.S. Military HIV</div>\n<div>\n Research Program (MHRP) is conducting a study on HIV vaccines. A vaccine is a medical product</div>\n<div>\n given to prevent certain diseases, most often infectious diseases. The vaccine may educate the</div>\n<div>\n human body to form a defensive response to try to prevent the disease from the beginning or taking</div>\n<div>\n hold of the body. This defensive response called the immune response, and it is the body’s way</div>\n<div>\n to fight infections.</div>\n<div>\n The experimental HIV vaccines tested in this study are Env-C Plasmid DNA and HIV Env gp145</div>\n<div>\n C.6980 protein given with different adjuvants to increase the immune response. An adjuvant is a</div>\n<div>\n substance added to vaccines that can help to make the vaccine more effective by improving the</div>\n<div>\n immune response or causing the immune response to last longer than without the adjuvant. These</div>\n<div>\n adjuvants are mixed with the vaccines and injected into the muscle or placed on top of the skin.</div>\n<div>\n The HIV vaccines contain a piece of genetic material or a protein copied from the HIV virus cover</div>\n<div>\n (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or</div>\n<div>\n Acquired Immune Deficiency Syndrome (AIDS).</div>\n<div>\n The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and</div>\n<div>\n are tolerable, whether humans respond, (develop immune responses) to the vaccines, and how long</div>\n<div>\n the effects of study vaccines last. This study will also compare the effects (both good and bad) of</div>\n<div>\n the study vaccines with adjuvants and adjuvant patch to those of placebo injections and adjuvant</div>\n<div>\n patch. The placebo will consist of saline (sterile saltwater), look just like the study vaccines with</div>\n<div>\n adjuvants and will be given the same way, but will have no active vaccine or adjuvant in it.</div>\n<div>\n Study objectives will be met by the testing of blood samples from all participants. Willing and</div>\n<div>\n eligible participants have the option to provide lymph node and mucosal secretion samples (semen,</div>\n<div>\n cervicovaginal, rectal) will provide the data for objectives 2 and the sub-objections.</div>\n<div>\n The sponsor of this study is National Institute of Allergy and Infectious Diseases (NIAID) Division</div>\n<div>\n of AIDS (DAIDS), and the Military HIV Research Program (MHRP), a part of the Walter Reed</div>\n<div>\n Army Institute of Research (WRAIR), funds it. A total of 126 participants will take part in this</div>\n<div>\n study.</div>\n
      • short_titleRV 460 HIV Vaccine Trial
      • protocol_noECCT/20/07/02
      • version_no2.0
      • date_of_protocol29-02-2020
      • study_drugEnv-C Plasmid DNA vaccine; HIV-1 ENV GP145 C.6980; DMLT; ALF43; REHYDRAGEL®; 0.9% SODIUM CHLORIDE FOR INJECTION
      • disease_conditionHIV
      • 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
      • comparatorYes
      • comparator_name0.9% SODIUM CHLORIDE FOR INJECTION
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan0
      • applicant_contractual_agreement1
      • declaration_applicantJosphat Kosgei
      • declaration_date130-07-2020
      • declaration_principal_investigatorJosphat Kosgei
      • declaration_date230-07-2020
      • placebo_presentYes
      • study_objectives<div>\n PRIMARY</div>\n<div>\n Assess the safety and tolerability (including reactogenicity) of Env-C Plasmid DNA given IM,</div>\n<div>\n alone, admixed with ALF43 adjuvant, topically applied with dmLT adjuvant, or given with an</div>\n<div>\n adjuvanted HIV Env gp145 C.6980 protein and followed by adjuvanted HIV Env gp145</div>\n<div>\n C.6980 protein boost IM immunizations, with or without Env-C Plasmid DNA.</div>\n<div>\n 2.6.2 SECONDARY</div>\n<div>\n 1. Determine whether the adjuvants under study improve the immunogenicity of</div>\n<div>\n the Env-C Plasmid DNA priming.</div>\n<div>\n 2. Determine whether the addition of ALF43 to the Rehydragel® –HIV Env</div>\n<div>\n gp145 C.6980 protein boost further improves the immune response to HIV Env</div>\n<div>\n gp145 C.6980 protein.</div>\n<div>\n 3. Determine whether adjuvants improve humoral responses across vaccination</div>\n<div>\n regimens.</div>\n<div>\n 4. Evaluate the influence of various adjuvants on cellular immune responses.</div>\n<div>\n 5. Describe mucosal humoral responses across vaccination regimens in</div>\n<div>\n cervicovaginal and rectal secretions and semen.</div>\n<div>\n 2.6.3 EXPLORATORY</div>\n<div>\n 1. Characterize B-cell functional specificities for each vaccination regimen.</div>\n<div>\n 2. Characterization of innate immunity.</div>\n<div>\n 3. Assess the innate/gene expression induced across vaccination regimens (DNA</div>\n<div>\n microarray, RNA sequencing) to compare relative influence of various</div>\n<div>\n adjuvants in the gene expression profiles of sorted T cell, B cell and innate cell</div>\n<div>\n subsets.</div>\n<div>\n 4. Perform systems serology analyses.</div>\n
      • principal_inclusion_criteria<div>\n INCLUSION CRITERIA</div>\n<div>\n 1. Healthy, male and female participant aged 18 to 40 years and available for 26</div>\n<div>\n months</div>\n<div>\n 2. Must be at low risk for HIV infection per investigator assessment and using</div>\n<div>\n the study risk assessment tool.</div>\n<div>\n 3. Must be able to understand and complete the informed consent process.</div>\n<div>\n 4. Must be capable of reading English or Kiswahili.</div>\n<div>\n 5. Must agree to a home visit.</div>\n<div>\n 6. Must complete a Test of Understanding (TOU) before enrollment. Must</div>\n<div>\n answer 9 out of 10 questions correctly, with a maximum of three attempts.</div>\n<div>\n 7. Must be in good general health without a clinically significant medical history.</div>\n<div>\n 8. HIV-uninfected per diagnostic algorithm within 45 days of enrollment.</div>\n<div>\n 9. Laboratory values:</div>\n<div>\n • Hemoglobin:</div>\n<div>\n 12.5-18.1 g/dL men</div>\n<div>\n 11.0-16.1 g/dL women</div>\n<div>\n • White Cell Count:</div>\n<div>\n 2.7-7.7 x 103 cells/μL men</div>\n<div>\n 3.0-9.1 x 103 cells/μL women</div>\n<div>\n • Platelets:</div>\n<div>\n 125-370 103 cells/μL men</div>\n<div>\n 125-444 103 cells/μL women</div>\n<div>\n • ALT and AST: ≤1.25 institutional upper limit of the reference range</div>\n<div>\n Creatinine: ≤1.25 institutional upper limit of the reference range</div>\n<div>\n • Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose</div>\n<div>\n Female-Specific Criteria:</div>\n<div>\n 10. Negative urine pregnancy test for women at screening, the day of each</div>\n<div>\n vaccination, and before any invasive procedure.</div>\n<div>\n 11. Already using and commits to continued use of an adequate birth control</div>\n<div>\n method for 45 days before to the first vaccine/placebo vaccination and for at</div>\n<div>\n least 90 days after the final vaccine/placebo vaccination. Adequate birth</div>\n<div>\n control is defined as follows: Contraceptive medications delivered orally,</div>\n<div>\n intramuscularly, vaginally, or implanted, underneath the skin, surgical</div>\n<div>\n methods (hysterectomy or bilateral tubal ligation), condoms with spermicide,</div>\n<div>\n diaphragms, intrauterine device (IUD), vasectomy in a monogamous partner,</div>\n<div>\n or abstinence.</div>\n
      • principal_exclusion_criteria<div>\n EXCLUSION CRITERIA</div>\n<div>\n A history of:</div>\n<div>\n 1. Three or more sexual partners in the previous 24 weeks</div>\n<div>\n 2. Commercial sex work</div>\n<div>\n 3. Non-adherence to condom use in the absence of a long-term monogamous</div>\n<div>\n relationship</div>\n<div>\n 4. Intravenous drug use in the previous year.</div>\n<div>\n 5. A sexually transmitted infection in the previous 24 weeks</div>\n<div>\n 6. Asplenia: any condition resulting in the absence of a functional spleen</div>\n<div>\n 7. Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency,</div>\n<div>\n coagulopathy, or platelet disorder requiring special precautions)</div>\n<div>\n 8. Breastfeeding or pregnant (positive pregnancy test) women or planning to</div>\n<div>\n become pregnant during the window between study enrollment and three</div>\n<div>\n months after the last vaccination visit.</div>\n<div>\n 9. Any past, ongoing, or in remission history of treated or untreated autoimmune</div>\n<div>\n disease.</div>\n<div>\n 10. Has known active Hepatitis B virus infection (or positive HBsAg).</div>\n<div>\n 11. History of anaphylaxis or other serious adverse reaction to vaccines or allergies</div>\n<div>\n or reactions likely to be exacerbated by any component of the vaccine and</div>\n<div>\n placebo, including antibiotics or excipients</div>\n<div>\n 12. Absolute Neutrophil Count (ANC):</div>\n<div>\n <1.0 x 103 cells/μL</div>\n<div>\n 13. Participant has received any of the following substances:</div>\n<div>\n • Chronic use of therapies that may modify immune response, such as intravenous</div>\n<div>\n (IV) immune globulin and systemic corticosteroids (in doses of >20 mg/day</div>\n<div>\n prednisone equivalent for periods exceeding 10 days)</div>\n<div>\n • The following exceptions are permitted and will not exclude study participation:</div>\n<div>\n o use of corticosteroid nasal spray for rhinitis,</div>\n<div>\n o topical corticosteroids for an acute uncomplicated dermatitis; or</div>\n<div>\n o A short course (10 days or less, or a single injection) of corticosteroid for a</div>\n<div>\n non-chronic condition (based on investigator clinical judgment) at least 2</div>\n<div>\n weeks before enrollment.</div>\n<div>\n 14. Blood products within 120 days before HIV screening</div>\n<div>\n 15. Immunoglobulins within 30 days before HIV screening</div>\n<div>\n 16. Any experimental vaccine containing an adjuvant other than aluminum or an</div>\n<div>\n adjuvant not approved by the FDA or European Medicines Agency (EMA) as</div>\n<div>\n part of a licensed vaccine.</div>\n<div>\n 17. CERVARIX vaccine against HPV (containing AS04)</div>\n<div>\n 18. Receipt of any investigational HIV vaccine, investigational research agents or</div>\n<div>\n vaccine within 30 days before enrollment.</div>\n<div>\n 19. Anti-tuberculosis prophylaxis or therapy during the past 90 days before</div>\n<div>\n enrollment</div>\n<div>\n 20. Any psychiatric, social condition, occupational reason, or other responsibility</div>\n<div>\n that, in the judgment of the investigator, is a contraindication to protocol</div>\n<div>\n compliance or impairs a participant’s ability to give informed consent</div>\n<div>\n 21. Major psychiatric illness and or substance abuse problems during the past 12</div>\n<div>\n months that, in the opinion of the investigator, would preclude participation</div>\n<div>\n 22. History of atopy or significant skin conditions</div>\n<div>\n 23. Study site employees who are involved in the protocol and or may have direct</div>\n<div>\n access to the study-related area</div>\n<div>\n Final evaluation of eligibility is based on the medical judgment of the investigator. The PSRT will</div>\n<div>\n also remain available to PI for consultation if desired.</div>\n
      • primary_end_points<div>\n The primary endpoints of this Phase 1 study are related to the safety, reactogenicity and tolerability</div>\n<div>\n of the Env-C Plasmid DNA vaccine regimens. These will be monitored by PSRT and SMC as</div>\n<div>\n appropriate, and SAE), AEs and PIMMC will be recorded until the end of the trial.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • 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_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n USAMRD-A is a Special Foreign Activity of WRAIR, Silver Spring, Maryland (MD). USAMRDA</div>\n<div>\n includes the Kericho, Kenya unit affiliated through a Cooperative Agreement with KEMRI. The</div>\n<div>\n unit was activated on a temporary basis in 1969 at the invitation of the Government of Kenya to</div>\n<div>\n study trypanosomiasis. The success of that initial venture led to the establishment of a permanent</div>\n<div>\n activity in 1973. Over the past 45 years, research has been conducted on malaria, trypanosomiasis,</div>\n<div>\n leishmaniasis, entomology, HIV/AIDS, Polio, Ebola, Tuberculosis (TB), arboviruses, and other</div>\n<div>\n infectious diseases, with more than 250 manuscripts published.</div>\n<div>\n The USAMRD-A HIV Program is a component of MHRP. In Kenya, the HIV Program field site</div>\n<div>\n is located at KEMRI/USAMRD-A/Clinical Research Center (CRC) about 260 kilometers</div>\n<div>\n northwest of Nairobi along the Nairobi-Kisumu highway in the rural Kenyan town of Kericho.</div>\n<div>\n Kericho’s county population is approximately 752,396 (2009 census), although the larger</div>\n<div>\n catchment area for both HIV research and treatment is approximately 3 million covering the</div>\n<div>\n southern portion of the Rift Valley Province. Kericho is located among the African Highlands in</div>\n<div>\n the Rift Valley and well known for the growing of tea that forms the rolling “seas of green” within</div>\n<div>\n the tea plantations. The primary industry in this region is tea farming, with two large international</div>\n<div>\n tea companies namely Finlay’s Kenya Ltd and Unilever Tea Kenya Ltd, centered in Kericho</div>\n<div>\n County Referral Hospital (KCRH).</div>\n<div>\n Kericho was ranked as the twentieth richest county in Kenya in the 2005/06 National Integrated</div>\n<div>\n Household Budget Survey. Income in Kericho comes mainly from agricultural activities, with</div>\n<div>\n about 40-50% of the population living below the poverty line. The annual national gross domestic</div>\n<div>\n product per capita in 2013 averaged 1,245.51 U.S. dollars (USD). In Kenya, the age of majority</div>\n<div>\n (i.e. legal age of recognized adulthood or independence) is 18 years. The Kenyan national literacy</div>\n<div>\n level according to the Kenya Adult Literacy Survey report published in March 2007 by the Kenya</div>\n<div>\n National Bureau of Statistics was 64%. In Kericho, the literacy level is 74.3% in men and 68.9%</div>\n<div>\n in women. The government through a network of hierarchical public hospitals, health centers,</div>\n<div>\n primarily provides the healthcare system in the larger Kericho area (southern Rift Valley) and</div>\n<div>\n dispensaries ran by the Kenya Ministry of Health (MoH). The government health facilities do not</div>\n<div>\n charge for treatment but levy a small fee for facility maintenance, which can be waived for those</div>\n<div>\n not able to pay. In addition to government health care facilities, there are a few faith-based and</div>\n<div>\n private health care facilities providing services at a small fee. Access to most health care facilities</div>\n<div>\n is good given that there exists a reliable public transport system in the region.</div>\n<div>\n The KEMRI/USAMRD-A CRC is the primary HIV research site in USAMRD-A. Situated on the</div>\n<div>\n grounds of the KCRH/MoH, the 55,050 square feet CRC supports both HIV research and care and</div>\n<div>\n treatment in the southern Rift Valley Province. The CRC is composed of a clinical area including</div>\n<div>\n a central pharmacy that can support both vaccine and therapeutic studies as well as provide</div>\n<div>\n additional non-study medicines for HIV and other non-study related care. The CRC is a designated</div>\n<div>\n satellite HIV and TB clinic under the KCRH.</div>\n<div>\n The CRC laboratory is Kenya’s first and the only College of American Pathologist (CAP)</div>\n<div>\n accredited laboratory and boasts of a state-of-the-art Information Technology (IT) center that</div>\n<div>\n supports both HIV research and treatment programs. Both the CRC pharmacy and laboratory are</div>\n<div>\n approved by NIAID/DAIDS to participate in DAIDS sponsored vaccine (Site #31352) and</div>\n<div>\n therapeutics AIDS Clinical Trials Group (ACTG Site #12501); International Maternal Pediatric</div>\n<div>\n Adolescent AIDS Clinical Trials (IMPAACT site #5121) studies, the only research site with such</div>\n<div>\n approval in Kenya.</div>\n
      • other_details_explanation<p>\n Similar studies has been done in the host country (USA) before.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU</p>\n<p>\n WRAIR IRB</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration26 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator0.9% Normal Saline
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/US MRDA-A/K, KERICHO
      • single_site_physical_addressHOSPITAL ROAD
      • single_site_contact_personJosphat Kosgei
      • single_site_telephone254729110122
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteOne site only
      • total_participants_worldwide126
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJosphat
      • investigator1_middle_nameKiprop
      • investigator1_family_nameKosgei
      • investigator1_qualificationMBChB; MSc; DLSHTM
      • investigator1_professional_addressKEMRI WRP
      • investigator1_telephone254 729 110 122
      • investigator1_emailjosphat.kosgei@usamru-k.org
      • organisations_transferred_Yes
      • number_participants126
      • notification
      • approval_date19-10-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-09-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved by the Expert Committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-10-08 11:29:13
      • created2020-07-30 11:57:43
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id570
        • application_id923
        • given_nameJosphat
        • middle_name
        • family_nameKosgei
        • qualificationMBChB; MSc; DLSHTM
        • professional_addressKEMRI WRP
        • telephone254 729 110 122
        • emailjosphat.kosgei@usamru-k.org
        • created2020-07-30 12:20:14
        • modified2021-09-16 13:14:50
    • SiteDetail(array)
      • 0(array)
        • id799
        • application_id923
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-07-30 12:20:14
        • modified2021-09-16 13:14:50
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id444
        • application_id923
        • sponsorUS NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
        • sponsor_typeOthers
        • contact_person
        • addressBethesda, Maryland
        • telephone_number301 500 3688
        • fax_number
        • cell_number301 500 3688
        • email_addresscpolyak@hivresearch.org
        • created2020-07-30 12:20:14
        • modified2021-09-16 13:14:50
  • 4(array)
    • Application(array)
      • id907
      • user_id633
      • trial_status_id(null)
      • abstract_of_study<p>\n <strong>Background: </strong>Covid-19 pandemic is as a result of infection with SARS-COV2. There are no effective antiviral drugs and no vaccines yet making use of convalescent plasma therapy reasonable.</p>\n<p>\n <strong>Objectives</strong>: The primary objective of this study is to evaluate safety and efficacy of convalescent plasma therapy plus standard treatment versus standard treatment alone in patients with severe Covid-19 disease.</p>\n<p>\n <strong>Trial design</strong>: Randomized open label controlled trial</p>\n<p>\n <strong>Sample size</strong>: 103 experimental group and 103 control group</p>\n<p>\n <strong>Participants</strong>: Adults aged >18yrs who meet inclusion criteria and give informed written consent to donate whole blood at least 14 days after initial disease with 2 negative RT-PCR for SARS-COV2 and are asymptomatic. The whole blood with be filtered by a gravity driven microfiltration device, Hemoclear into plasma and packed cells. Recipients of convalescent plasma will be adults >18yrs old who meet inclusion criteria and have severe Covid-19 disease.</p>\n<p>\n <strong>Intervention and comparator</strong>: Standard treatment for Covid-19 plus 350mls of convalescent plasma transfused over 4 hours compared with standard treatment alone</p>\n<p>\n <strong>Outcomes</strong>. The primary outcome will be to evaluate adverse events and time to clinical improvement as defined by WHO ordinal scale between experimental group and control group. Secondary outcomes will include comparing duration of length of ICU stay, duration of mechanical ventilation, duration of hospital stay, oxygen requirements, rate of turning negative SARS-COV2 test and all-cause mortality in 28 days between the experimental therapy and control therapy.</p>\n<p>\n <strong>Trial status</strong>: Approved by PPB</p>\n<p>\n <strong>Trial registration</strong>: Pan African Clinical Trials Registry (PACTR202007653923168).</p>\n
      • study_title<p>\n <strong>A randomized control trial comparing convalescent plasma therapy plus standard treatment versus standard treatment alone in patients with severe COVID-19 pneumonia at a tertiary hospital</strong></p>\n
      • laymans_summary<p>\n COVID 19 pandemic is caused by a virus called SARS COV2 that was first identified in Wuhan, China in December 2019. So far, there is no effective treatment or vaccine for the virus. As of 13 June 2020, there are over 7 million reported cases in the world and Kenya had 3457 reported cases and 100 deaths. Use of plasma from patients who have recovered from various viruses to enhance the immunity of those with the virus and  help them fight it has shown promising results. However, this has only been demonstrated in small case reports. We plan to use a filtration device, Hemoclear, to separate plasma from blood donated by COVID 19 recovered patients and then give this plasma to COVID 19 patients showing signs and symptoms of severe disease to help them fight the disease and ensure quick recovery. Studies have shown patients with COVID 19 usually have developed enough antibodies by day 15 of the disease. Using statistics, we need atleast 206 patients randomly assigned to the group of convalescent plasma and standard treatment to show any difference between the 2 groups. Only group specific and infection free blood will be used. This study will happen at Kenyatta University Teaching Referral and Research hospital   </p>\n
      • short_titleConvalescent plasma trial
      • protocol_noECCT/20/07/01
      • version_no4
      • date_of_protocol12-09-2020
      • study_drugConvalescent plasma
      • disease_conditionCovid 19
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals1
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameHemoclear
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskadembesa@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_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_agreement0
      • declaration_applicantDr Isaac Adembesa
      • declaration_date115-07-2020
      • declaration_principal_investigatorDr Isaac Adembesa
      • declaration_date215-07-2020
      • placebo_presentNo
      • study_objectives<p style=\"margin-left:.75in;\">\n <strong> Primary Objective</strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n To evaluate safety of convalescent plasma therapy in patients with severe COVID-19.</li>\n <li>\n To evaluate efficacy of convalescent plasma therapy with standard treatment versus standard treatment alone with respect to time to clinical improvement (TTCI) [Time Frame: up to 28 days].</li>\n</ol>\n<p>\n TTCI is defined as the time (in days) from initiation of study treatment (active or standard care) until a decline of two categories from admission status on a six-category ordinal scale of Clinical status which ranges from 1 (discharged) to 6 (death).</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Six-category ordinal scale:</strong></p>\n<p>\n 6. Death</p>\n<p>\n 5. ICU, requiring IMV;</p>\n<p>\n 4. ICU/hospitalization, requiring NIV/ HFNC therapy;</p>\n<p>\n 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);</p>\n<p>\n 2. Hospitalization, not requiring supplemental oxygen;</p>\n<p>\n 1. Hospital discharge.</p>\n<p>\n Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.</p>\n<p>\n  </p>\n<p style=\"margin-left:54.75pt;\">\n <strong>Secondary objectives</strong></p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n To compare duration of severe illness, based on SOFA score, between patients enrolled in the intervention and control groups assessed by the ordinal scale on days 7, 14, 21, and 28.</li>\n <li>\n To compare the proportion of patients requiring oxygen supplementation between the intervention and control groups up to 28 days.</li>\n <li>\n To compare the proportion of patients on mechanical ventilation between the intervention and control groups up to 28 days.</li>\n <li>\n To determine the mean PaO2/FiO2 between the intervention and control groups up to 28 days.</li>\n <li>\n To determine time to negative SARS-COV2 RT-PCR test in respiratory tract specimens between the intervention and control groups up to 28 days</li>\n <li>\n To determine the length of ICU stay(days) between the intervention and control groups up to 28 days.</li>\n <li>\n To determine length of hospital stay (days) between the intervention and control groups up to 28 days.</li>\n <li>\n To determine all-cause mortality between the intervention and control groups up to 28 days.</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n <strong>Inclusion criteria for donors of CP</strong></p>\n<p style=\"margin-left:46.35pt;\">\n (a) Confirmation of previous infection with SARS-CoV2 by a record of RT-PCR test result. At least 2 negative RT-PCR tests after recovery.</p>\n<p style=\"margin-left:46.35pt;\">\n (b) An interval of at least 14 days after initial illness which is assumed to be the day when the patient had a positive RT-PCR test for SARS-COV2.</p>\n<p style=\"margin-left:46.35pt;\">\n (c) Donor blood must have antibody titers against SARS-COV2 of >1:320</p>\n<p style=\"margin-left:46.35pt;\">\n (d)  Must meet standard criteria for whole blood donation according to Kenyan blood bank requirements and standards (age (>18yrs), weight (>50kg), collection frequency (at least 3 months since last donation), vital signs within normal ranges, good health) in line with WHO Blood Regulators Network (BRN): Donor selection in case of pandemic situations’ .</p>\n<p style=\"margin-left:46.35pt;\">\n (e) Non-reactivity of blood samples for transfusion transmitted infections including HIV, HBV, HCV, syphilis (for whole blood) and malaria</p>\n<p>\n (f) To avoid the risk of transfusion-related acute lung injury (TRALI), preference will be given to use of plasma from male donors or from female donors who have never been pregnant including abortions. This measure lowers the possibility of presence in the plasma of the antibodies to HLA or granulocyte antigens that cause TRALI. TRALI occurs within 6 h after transfusion of implicated plasma and can be severe</p>\n<p>\n <strong>Inclusion Criteria for recipients of CP: </strong></p>\n<ol>\n <li>\n Confirmed Covid-19 patients with severe disease defined as oxygen saturation ≤ 93 in resting state and PaO2/FiO2 ≤300mmHg who have understood and signed the written informed consent form.</li>\n <li>\n Critically ill COVID-19 patients. If patients are eligible but are too sick to give consent, their legally authorized close relatives will consent for them.</li>\n <li>\n Age ≥18 years, gender unlimited</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p style=\"margin-left:46.35pt;\">\n <strong>Exclusion criteria for donors of CP</strong></p>\n<p>\n  </p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Patients aged less than 18 years of age (18 years is the legal consent age in Kenya)</li>\n <li>\n Symptomatic patients with COVID-19</li>\n <li>\n Patients with fever of unknown origin</li>\n <li>\n Patients who don’t meet Kenyan standards of blood donation e.g. anemic patients, underweight (less than 50kg), chronic diseases such as HIV, hepatitis B and C, cancers, uncontrolled hypertension etc.</li>\n <li>\n Females who have given birth or had an abortion due to high risk of TRALI</li>\n <li>\n Patients who decline or are unable to give informed consent to donate CP.</li>\n <li>\n Donors with antibody titers to SARS-COV2 < 1:320</li>\n</ol>\n<p>\n <strong>Exclusion Criteria for recipients of CP:</strong></p>\n<ul>\n <li>\n History of allergic reaction to blood or blood products</li>\n <li>\n Participation in other clinical trials.</li>\n <li>\n Religious reasons such as Jehovah witnesses’ practitioners who decline blood/blood products.</li>\n <li>\n Refusal to give informed consent by the patient or next of kin</li>\n <li>\n Known IgA deficiency</li>\n <li>\n Medical conditions in which receipt of 350mL volume may be detrimental to the patient (e.g., decompensated congestive heart failure, renal failure)</li>\n <li>\n Females who are pregnant or breast feeding</li>\n <li>\n Patients who have already developed antibodies to SARS-COV2 with titers >1:80. This is because of risk of antibody dependent enhancement</li>\n</ul>\n
      • primary_end_points<p>\n 1. To evaluate safety of CP by observing for severe adverse events</p>\n<p>\n 2.Time to clinical improvement between the two groups</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Dr Kariuki Ngugi, MBChB, MMED Anaesthesia</p>\n<p>\n Dr Sultana Sherman, MBChB, MMED Anaesthesia</p>\n<p>\n Dr Mary Mwangi, MBChB, MMED Anaesthesia</p>\n<p>\n Prof Olive Mugenda, BA, MBA, PhD</p>\n<p>\n Dr Mutambuki Kimondo, MBChB, MMED Pathology</p>\n<p>\n Dr Antony Kamau, BPharm, MSc Pharmacotherapy</p>\n<p>\n Dr Edward Njogu, MBChB, MMED Internal Medicine, Fellowship Nephrology</p>\n<p>\n Dr Angela Ongewe, MBChB, MMED Anaesthesia, Fellowship Cardiothoracic Anaesthesia</p>\n<p>\n Dr Samuel Akech, MBChB, MMED Pediatrics, PhD</p>\n<p>\n Dr Marion Kiguoya-Njau, BSc, MSc, PhD</p>\n<p>\n Dr Eric Bosire, MBChB</p>\n<p>\n Dr Diane Otieno, MBChB</p>\n<p>\n Dr Maureen Nganga, MBChB</p>\n<p>\n Dr John Kaumba Nzioka, MBChB</p>\n<p>\n Mercy Kahare, BA, MSc Medical records</p>\n<p>\n Wilfred Gatua, BSc, MSc Medical laboratory</p>\n<p>\n KUTRRH has a 14 bed blood donation centre and a blood bank that meets international standards. The hospital has a capacity of 650 beds and 24 ICU dedicated for Covid 19 positive patients</p>\n
      • other_details_explanation<p>\n Covid 19 cases are on the rise in Kenya with a projected peak in September and November 2020.With the promising results from pilot studies on convalescent plasma therapy, we hope this study will give an insight into its efficacy.</p>\n
      • other_details_regulatory_notapproved<p>\n 1. National Commission for Science Technology and Innovation 13.7.2020</p>\n<p>\n 2. Pan African Clinical Trials Registry 15.7.2020</p>\n
      • other_details_regulatory_approved<p>\n 1. Kenyatta University Teaching Referral and Research Hospital Clinical Research Support Committee 22.7.2020 1 site</p>\n<p>\n 2. Kenyatta University Ethics Review Committee 10.7.2020 1 site</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration12 months
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStandard treatment
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKenyatta University Teaching Referral and Research Hospital
      • single_site_physical_address7674-00100, Nairobi
      • single_site_contact_personDr Isaac Adembesa
      • single_site_telephone0720949430
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site206
      • total_participants_worldwide206
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Isaac Adembesa
      • investigator1_middle_name
      • investigator1_family_nameKadambi
      • investigator1_qualificationMBChB, MMED Anaesthesia, Fellowship in Cardiothoracic Anaesthesia
      • investigator1_professional_address7674-00100, Nairobi
      • investigator1_telephone0720949430
      • investigator1_emailkadembesa@yahoo.com
      • organisations_transferred_No
      • number_participants206
      • notification<p>\n None</p>\n
      • approval_date25-09-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted05-10-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonEdwardabwao
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2021-07-11 14:19:18
      • created2020-06-15 09:19:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id562
        • application_id907
        • given_nameDr Isaac Adembesa
        • middle_name
        • family_nameKadambi
        • qualificationMBChB, MMED Anaesthesia, Fellowship in Cardiothoracic Anaesthesia
        • professional_address7674-00100, Nairobi
        • telephone0720949430
        • emailkadembesa@yahoo.com
        • created2020-06-15 10:26:23
        • modified2020-10-05 15:18:11
    • SiteDetail(array)
      • 0(array)
        • id784
        • application_id907
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-06-15 10:26:23
        • modified2020-10-05 15:18:11
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id437
        • application_id907
        • sponsorKenyatta University Teaching Research and Referral Hospital
        • sponsor_typeResearch Institution
        • contact_person
        • address7674 00100, Nairobi
        • telephone_number0720949430
        • fax_number
        • cell_number0720949430
        • email_addressinfo@kutrrh.go.ke
        • created2020-06-15 10:26:23
        • modified2020-10-05 15:18:11
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(empty)
• $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