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• applications(array)
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    • Application(array)
      • id213
      • user_id77
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong> Adherence to HIV prevention and contraception technologies is imperfect but is key to effectiveness. The options currently available to protect women from HIV infection and unwanted pregnancy (e. g. condom use, abstinence, monogamy) are not consistently available, practical, or under women’s control. Intravaginal rings (IVRs) are an important technology that can be long-acting and woman-controlled and are being developed for HIV prevention with and without co-formulated hormonal contraception. Availability of IVRs in sub-Saharan Africa is limited; hence, it is important to evaluate acceptability, utilization, and biologic effects of IVR usage among African women. The NuvaRing® intravaginal combined hormonal contraceptive ring is used successfully in 61 countries worldwide, although not currently in Kenya. NuvaRing is self-inserted for 21 days starting after the last day of menses then removed for seven days to allow menses to occur, and has comparable effectiveness to oral contraceptives. In preparation for a potential future Phase 2 trial of a combination antiretroviral-contraceptive IVR, KEMRI/CDC proposes to examine adherence, acceptability and biological effects of NuvaRing® among contracepting Kenyan women.</p>\n<p>\n  </p>\n<p>\n <strong>Objectives:</strong></p>\n<ol>\n <li>\n To assess adherence and utilization patterns for NuvaRing®, behaviourally and biologically.</li>\n <li>\n To assess acceptability and effect of NuvaRing® on sexual behaviour among women and their sexual partners in a setting where there is no routine IVR use. At the end of the NuvaRing® trial, to additionally assess the hypothetical acceptability of a prototype dual use HIV-prevention and contraceptive IVR among women who had used NuvaRing® and among women who have never used an IVR.</li>\n <li>\n To assess biologic effects of NuvaRing® including standard safety monitoring and, among a subset of participants, genital compartment immunology and microbiology.</li>\n</ol>\n<p>\n <strong>Study Subjects: </strong>A total of 220 women and 20 men will be enrolled in different parts of the proposed study. The primary NuvaRing® trial participants (Objectives 1 and 2 above) will be up to 200 young, healthy women recruited from family planning clinics in the Kisumu catchment area. Fifty of these will form a biomedical subgroup addressing Objective 3. To augment Objective 2, twenty trial participants and their sexual partners will take part in a qualitative in-depth interview, and three focus group discussions will be conducted, one with study participants and the others with 20 women who were not part of the primary NuvaRing® trial<strong>. </strong></p>\n<p>\n  </p>\n<p>\n <strong>Design:</strong> Single arm clinical trial with up to 3 month pre-product phase (on oral or injectable contraceptives) followed by 6 months of IVR use, ending with an up to 3 month post-product phase during which women return to oral or injectable contraceptives and then exit study. Monthly and quarterly follow-up will include adherence, acceptability and clinical assessments, HIV and pregnancy testing. Women in biomedical subgroup will undergo more frequent visits and collection of genital specimens. In-depth interview and focus group discussions are delineated under ‘Study Subjects’ above.</p>\n<p>\n  </p>\n<p>\n <strong>Outcome:</strong> The study will improve understanding of adherence to biomedical technologies, facilitate the conduct of future HIV microbicide clinical trials relying on IVR technology, and inform public health practice regarding contraception. </p>\n
      • study_title<p>\n <strong>Clinical Trial of Acceptability, Adherence and Biologic Effects of a Vaginal Contraceptive Ring among Women in Western Kenya</strong></p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/10/01
      • version_no3
      • date_of_protocol18-09-2013
      • study_drugEthinylestradiol/Etonogestrel
      • disease_conditionContraception
      • 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_nameEthinylestradiol/Etonogestrel
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • applicant_pictorial_sample(null)
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      • applicant_contractual_agreement(null)
      • declaration_applicantFredrick O. Otieno
      • declaration_date111-09-2013
      • declaration_principal_investigatorFredrick Otieno
      • declaration_date211-09-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n To be included in the NuvaRing® trial (excluding the FGD participants drawn from outside the trial population), participants will need to meet the following criteria:</p>\n<p style=\"margin-left:.25in;\">\n ·         18 to 34 years of age <strong>– Age will be verified using a standard national document e.g. Identity card, birth notification e.t.c. and in case they are missing we will rely on proxy verification</strong></p>\n<p style=\"margin-left:.25in;\">\n ·         Fluent in English, Swahili, or DhoLuo</p>\n<p style=\"margin-left:.25in;\">\n ·         Resident of the Kisumu catchment area (≈150 kilometres from Kisumu City)</p>\n<p style=\"margin-left:.25in;\">\n ·         Able and willing to provide written informed consent</p>\n<p style=\"margin-left:.25in;\">\n ·         Willing to provide detailed locator information and not planning to relocate outside the study area for next 12 months</p>\n<p style=\"margin-left:.25in;\">\n ·         Engaged in more than one episode of vaginal intercourse on different days in the past 30 days</p>\n<p style=\"margin-left:.25in;\">\n ·         Female, not currently pregnant and not intending to get pregnant for the next 12 months</p>\n<p style=\"margin-left:.25in;\">\n ·         Demonstrated willingness to prevent conception for the next 12 months, based on:</p>\n<p style=\"margin-left:.75in;\">\n o   Documented receipt of three on-time monthly refills of OCPs, or one DMPA injection at a FP clinic in the last 3 months prior to enrolling in the study.</p>\n<p style=\"margin-left:.25in;\">\n ·         Willing to exclusively use IVR for contraception for the duration of the intervention phase of study. (Proper and consistent condom use will be encouraged and condoms will be provided for STI/HIV prevention)</p>\n<p style=\"margin-left:.25in;\">\n ·         HIV negative per Kenya’s HIV testing algorithm (using rapid tests)</p>\n<p style=\"margin-left:.25in;\">\n ·         Willing to undergo periodic study procedures including pregnancy testing, HIV and STI testing </p>\n
      • principal_exclusion_criteria<p>\n Participants will be excluded from the study based on:</p>\n<p style=\"margin-left:.25in;\">\n ·         <strong>Known medical contraindications:</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Thrombophlebitis or thromboembolic disorders (current or history)</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Cerebral vascular or coronary artery disease (current or history)</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Valvular heart disease with thrombogenic complications</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Severe hypertension</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Diabetes with vascular involvement</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Headaches with focal neurological symptoms</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Major surgery with prolonged immobilization</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Known or suspected carcinoma of the breast or personal history of breast cancer</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Undiagnosed abnormal genital bleeding</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Hepatic tumors (benign or malignant) or active liver disease</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Known or suspected pregnancy</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Heavy smoking (≥15 cigarettes per day) and over age 35</strong></p>\n<p style=\"margin-left:.75in;\">\n ·         <strong>Hypersensitivity to any of the components of</strong> NuvaRing®</p>\n<p style=\"margin-left:.25in;\">\n ·         Current breastfeeding or being within three months of parturition, at the time of screening.</p>\n<p>\n Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, reproductive, or allergic disease that would compromise the ability of the participant to provide informed consent, or to complete study procedures or study requirements as determined by the principal investigator or designated associate. The clinical significance of any abnormality is to be evaluated in the context of the safety of the patient volunteer and the objectives of this study. </p>\n
      • primary_end_points<p>\n Pregnancy at any of the three phases</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_others1
      • scope_others_specifyAcceptability and Adherence Evaluation
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study has employed the following cadre of staff: Study coordinator (1), Data manager (1), Programmer (1), Data analyst (1), Medical records technologist (2), Administrative assistants (2), Administrative officers (1), Regulatory officer (1), quality control officer (1), behavioural scientist (1), nurse counsellors (2), laboratory technologists (2), pharmaceutical technologist (1) and community intervoewers (5).<a>· The key study staff are as indicated below:        </a></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:633px;\" width=\"633\">\n <tbody>\n <tr>\n <td style=\"width:132px;\">\n <p>\n Fredrick O. Otieno</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n KEMRI Principal Investigator,</p>\n <p>\n Research Officer,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n DipClinMed, MPH</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n Tereza A. Omoro</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Investigator,</p>\n <p>\n Community Technician,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n DipCommunity</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n Arthur O. Ogendo</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Investigator,</p>\n <p>\n Research Officer,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n BA Sociology</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n Kenneth Ondeng’e</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Investigator,</p>\n <p>\n Assistant Research Officer,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n BA Sociology, MA</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n <strong>Beatrice A. Nyagol</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Clinician,</strong></p>\n <p>\n <strong>HIV Research Branch, </strong></p>\n <p>\n <strong>KEMRI/CDC, Kisumu</strong></p>\n </td>\n <td style=\"width:293px;\">\n <p>\n <b>DipClinMed</b></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n Victor Mudhune</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Pharmacist,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n B.Pharm</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:132px;\">\n <p>\n George Olilo</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Senior Data Manager,</p>\n <p>\n HIV Research Branch,</p>\n <p>\n KEMRI/CDC, Kisumu</p>\n </td>\n <td style=\"width:293px;\">\n <p>\n BSc (Stat), Msc</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n The study clinic is complete with 6 clinic room, pharmacy, 2 counselling rooms and computer ACASI room. Within the compound there is an ISO certified laboratory for clinical investogations. The clinic is located within the Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), which provide clinical support if and when needed. </p>\n
      • other_details_explanation<p>\n The Nuvaring (Ethinylestradiol/Etonogestrel) product is approved for market in the US after successive trials in country.The key objective of this study is to look at acceptability of vaginal inserts in the local population, and address underlying adherence concerns in the local (Kenyan) population. </p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KEMRI on 27th September 2013 (1 site in country)</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration18 months including enrollment period
      • design_controlled_randomisedNo
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overYes
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorDepot Medroxyprogesterone
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI/CDC Research and Public Health Collaboration
      • single_site_physical_addressP. O. Box 1578-40100, Kisumu
      • single_site_contact_personFredrick O. Otieno
      • single_site_telephone+254572022929
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site220
      • total_participants_worldwide220
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_nameOdhiambo
      • investigator1_family_nameOtieno
      • investigator1_qualificationDipClinMed, MPH
      • investigator1_professional_addressP.O. Box 1578-40100 Kisumu.
      • investigator1_telephone+254572022929
      • investigator1_emailFOtieno@Kemricdc.org
      • organisations_transferred_No
      • number_participants220
      • notification<p>\n None</p>\n
      • approval_date27-09-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted10-10-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
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      • final_report(null)
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      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-05-23 09:44:21
      • created2013-09-11 11:31:11
      • total_sites(null)
      • ecitizen_invoice(null)
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        • id146
        • application_id213
        • given_nameFredrick
        • middle_nameOdhiambo
        • family_nameOtieno
        • qualificationDipClinMed, MPH
        • professional_addressP.O. Box 1578-40100 Kisumu.
        • telephone+254572022929
        • emailFOtieno@Kemricdc.org
        • created2013-09-11 11:50:20
        • modified2013-10-10 12:11:01
      • 1(array)
        • id147
        • application_id213
        • given_nameLisa
        • middle_nameAnn
        • family_nameMills
        • qualificationMD, MSc.
        • professional_addressP.O. Box 1578-40100 Kisumu.
        • telephone+254572022929
        • emailLMILLS@KE.CDC.GOV
        • created2013-09-11 12:07:59
        • modified2013-10-10 12:11:01
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        • created2013-09-11 11:50:20
        • modified2013-10-10 12:11:01
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        • id115
        • application_id213
        • sponsorDivision of HIV/AIDS Prevention, U. S. Centers for Disease Control and Prevention
        • sponsor_type(null)
        • contact_personTaraz Samandari
        • address1600 Clifton Rd, Mailstop E-45. Atlanta, GA 30333. U. S. A.
        • telephone_number(404) 639-5173
        • fax_number
        • cell_number(404) 639-5173
        • email_addresstts0@cdc.gov
        • created2013-09-11 11:50:20
        • modified2013-10-10 12:11:01
  • 1(array)
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      • id206
      • user_id87
      • trial_status_id1
      • abstract_of_study<p>\n <strong>Study Size </strong>3200 patients</p>\n<p>\n <strong>Study Design </strong>Multicentre, international, blinded, randomized placebo controlled trial of dabigatran and omeprazole (partial factorial design among patients not taking a proton pump inhibitor [PPI]).</p>\n<p>\n <strong>Primary Objectives</strong></p>\n<p>\n To determine the impact of dabigatran versus placebo on the risk of a major vascular complication and omeprazole versus placebo on the risk of a major upper gastrointestinal complication in patients who are followed on average for 1 year.</p>\n<p>\n <strong>Safety Objectives</strong></p>\n<p>\n To determine the impact of dabigatran on the following individual outcomes: life-threatening bleeding, major bleeding, minor bleeding, intracranial bleeding, significant lower gastrointestinal bleeding, non-significant lower gastrointestinal bleeding, or dyspepsia. To determine the impact of omeprazole on the following individual outcomes: Clostridium difficile-associated diarrhea, diarrhea, community-acquired pneumonia, and fractures.</p>\n<p>\n <strong>Inclusion Criteria</strong></p>\n<p>\n Patients are eligible if they fulfill <strong>all </strong>of the following criteria: 1. undergone noncardiac surgery; 2. ≥45 years of age; 3. have suffered myocardial injury after noncardiac surgery (MINS) based upon fulfilling <strong>one </strong>of the following criterions:</p>\n<p>\n A. elevated troponin or CK-MB measurement with one or more of the following defining features: i. ischemic signs or symptoms; ii. development of pathologic Q waves; iii. electrocardiogram changes indicative of ischemia (i.e., ST segment elevation, ST segment depression, or inversion of T waves); iv. new LBBB, or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging.</p>\n<p>\n B. elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism) to MINS. and 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS.</p>\n<p>\n <strong>Exclusion Criteria</strong></p>\n<p>\n Patients are excluded if they fulfill any of the following criteria: 1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. Hemorrhagic disorder or bleeding diathesis; 4. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, VTE, atrial fibrillation); 5. currently using or plan rifampicin, ketoconazole, or dronedarone; 6. women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 7. patient is considered unreliable for study follow-up or study drug compliance; OR 8. previously enrolled in MANAGE. We will also exclude patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, and/or elastic stockings are not sufficient for VTE prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling epidural or spinal catheter that cannot be removed; 4. estimated glomerular filtration rate <35 ml/min, OR 5. it is expected that the patient will undergo cardiac catheterization for MINS .</p>\n<p>\n <strong>Exclusion criteria specific to patients in the omeprazole factorial component:</strong></p>\n<p>\n 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. Patient declines participation in omeprazole arm.</p>\n<p>\n <strong>Treatment Regimen</strong></p>\n<p>\n Dabigatran 110mg (BID) or placebo and omeprazole 20 mg (once daily) or placebo for participants eligible for the PPI factorial component.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • study_title<h3 align=\"center\" style=\"color:blue;\">\n <span style=\"font-size:22px;\"><span style=\"font-family: times new roman,times,serif;\"><strong>M</strong><strong>anagement of myocardial injury After NoncArdiac surgGEry (MANAGE) Trial</strong></span></span></h3>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/08/06
      • version_no4.0
      • date_of_protocol30-11-2012
      • study_drugOmeprazole and Dabigatran
      • disease_conditionMyocardial Injury after Non Cardiac Surgery
      • 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
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresskenneth.juma@aku.edu
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKenneth Juma
      • declaration_date112-08-2013
      • declaration_principal_investigatorProf. Gerald Yonga
      • declaration_date212-08-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Patients are eligible if they fulfill all of the following criteria: 1. undergone noncardiac surgery; 2. ≥45 years of age; 3. have suffered myocardial injury after noncardiac surgery (MINS) based upon fulfilling one of the following criterions: A. elevated troponin or CK-MB measurement with one or more of the following defining features: i. ischemic signs or symptoms; ii. development of pathologic Q waves; iii. electrocardiogram changes indicative of ischemia (i.e., ST segment elevation, ST segment depression, or inversion of T waves); iv. new LBBB, or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging. B. elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism) to MINS. and 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS.</p>\n
      • principal_exclusion_criteria<p>\n Patients are excluded if they fulfill any of the following criteria: 1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. hemorrhagic disorder or bleeding diathesis; 4. condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart valve, VTE, atrial fibrillation); 5. currently using or plan rifampicin, ketoconazole, or dronedarone; 6. women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 7. patient is considered unreliable for study follow-up or study drug compliance; OR 8. previously enrolled in MANAGE. We will also exclude patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, and/or elastic stockings are not sufficient for VTE prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling<br />\n epidural or spinal catheter that cannot be removed; 4. estimated glomerular filtration rate <35 ml/min, OR 5. it is expected that the patient will undergo cardiac catheterization for MINS .</p>\n<p>\n Exclusion criteria specific to patients in the omeprazole factorial component:<br />\n 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. patient declines participation in omeprazole arm.</p>\n
      • primary_end_points<p>\n To determine the impact of dabigatran versus placebo on the risk of a major vascular complication and omeprazole versus placebo on the risk of a major upper gastrointestinal complication in patients who are followed on average for 1 year.</p>\n<p>\n To determine the impact of dabigatran on the following individual outcomes: life-threatening bleeding, major bleeding, minor bleeding, intracranial bleeding, significant lower gastrointestinal bleeding, non-significant lower gastrointestinal bleeding, or dyspepsia. To determine the impact of omeprazole on the following individual outcomes: Clostridium difficile-associated diarrhea, diarrhea, community-acquired pneumonia, and fractures.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 3 Staff Members</p>\n<p>\n 1. Dr. Gerald Yonga - Cardiologist and Associate professor of Medicine. Principal Investigator</p>\n<p>\n 2. Dr. Mzee Ngunga - Interventional Cardiologist, Faculty and Consultant. Co Principal Investigator</p>\n<p>\n 3. Mr Kenneth Juma - BSc. Microbiology and Biotechnology (UoN). Research Assistant and Trial Coordinator</p>\n
      • other_details_explanation<p>\n Not Applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p>\n 1. Aga Khan University Ethical Approval Board</p>\n<p>\n 2. Canada Research Ethics Board</p>\n<p>\n 3. Aga Khan Scientific Review Board</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2 YEARS
      • 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_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University Hospital, Nairobi
      • single_site_physical_addressOff Limuru Rd, 3rd parklands Ave, Aga Khan University Hospital, Department of Medicine, Cardiac Clinic ; 1st Floor Doctors Plaza,
      • single_site_contact_personProf. Gerald Yonga
      • single_site_telephone+254733655551
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states29
      • number_of_sites
      • multi_country_listArgentina, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, France, Germany, Greece, Hong Kong, India, Israel, Italy, Kenya, Netherlands, Nigeria, Peru, Philippines, Poland, Portugal, Russia, South Africa, Spain, Switzerland, Uganda, UK, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site40
      • total_participants_worldwide3200
      • 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_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_nameGERALD
      • investigator1_middle_name
      • investigator1_family_nameYONGA
      • investigator1_qualificationMBChB, MMED, FRCP, FACC, FASC
      • investigator1_professional_addressChair, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
      • investigator1_telephone+254 020 366 2117/2100/2110
      • investigator1_emailgerald.yonga@aku.edu
      • organisations_transferred_Yes
      • number_participants40
      • notification<p>\n The above attached is a Research checklist form containing a step by step approval process for all the Departments prior to institutional approval and signing of agreement. It ensures that all aspects of preparations and approvals are obtained and in order.</p>\n
      • approval_date30-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-08-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-11-29 10:22:03
      • created2013-08-12 16:12:59
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id137
        • application_id206
        • given_nameGERALD
        • middle_nameOCHIENG\'
        • family_nameYONGA
        • qualificationMBChB, MMED, FRCP, FACC, FASC
        • professional_addressChair, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
        • telephone+254 020 366 2117/2100
        • emailgerald.yonga@aku.edu
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
      • 1(array)
        • id138
        • application_id206
        • given_nameLEONARD
        • middle_nameMZEE
        • family_nameNGUNGA
        • qualificationMBChB, MMED, Cardiol Fellowship
        • professional_addressFaculty and Consultant, Department of Medicine, Aga Khan University Hospital, Nairobi, ETB - 6th Floor, P.O. Box 30270-00100, NRB
        • telephone+254 020 366 2795/2110
        • emailmzee.ngunga@aku.edu
        • created2013-08-12 16:23:54
        • modified2013-08-28 18:29:28
    • SiteDetail(array)
      • 0(array)
        • id169
        • application_id206
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id110
        • application_id206
        • sponsorMANAGE Project Office
        • sponsor_type(null)
        • contact_personSuzan O\'Donnell,
        • addressPOPULATION HEALTH RESEARCH INSTITUTE, Hamilton General Hospital Campus, DBCVSRI 237 Barton Street East, Hamilton, Ontario, Canada L8L 2X2
        • telephone_numberExt. 40508
        • fax_number905-297-3779
        • cell_number905-527-4322
        • email_addressSuzan.ODonnell@phri.ca
        • created2013-08-12 16:22:53
        • modified2013-08-28 18:29:28
  • 2(array)
    • Application(array)
      • id158
      • user_id81
      • trial_status_id8
      • abstract_of_study<p>\n Malaria transmission has been on the decline in some parts of Africa in association with scaling up of malaria control measures such as bed-nets and anti-malarials. However, transmission still persists and it appears that additional control measures including vaccination are required. The leading malaria vaccine candidate in development is RTS,S which has efficacy against clinical malaria measured at 30-50% in the field. This partial protection might be enhanced by combination with other components. The other vaccination approach that has produced repeatable efficacy in humans is the use of viral vectors to induce T cell responses.</p>\n<p>\n The field trials required to test malaria vaccines require large sample sizes and are laborious and time-consuming. Previous studies have relied on blood films to diagnose infection, but Polymerase Chain Reaction (PCR) based technology is considerably more sensitive, and therefore may reduce the sample size and period of monitoring required.   The first such trial was conducted in the Gambia. Adult subjects were recruited, treated with curative anti-malarials, and then followed up by daily finger-prick blood testing to identify the first episode of PCR-measured parasitaemia. Subjects given anti-malarial vaccine were compared with control subjects, and were less frequently parasitaemic as measured by PCR.</p>\n<p>\n We have recently repeated a similar trial design in Kenya (SSC no.2116) PPB/ECCT/11/12/02. Although the statistical analysis has remained blinded to vaccine allocation since data cleaning is incomplete, our examination of blinded data without reference to vaccination status gives cause for concern for two reasons; a) there are a substantial number of positives remaining after anti-malarials (i.e. atovaquone/proguanil and artesunate) were given (17%, compared with 60% prior to giving anti-malarials), and there are very few positive PCR results after drug clearance, and the majority are at low levels.</p>\n<p>\n We therefore propose a phase IIb trial design study that aims at determining the best anti-malarial drug regimen that will be used in future malaria vaccine trials to clear parasites before carrying out tests to check if a malaria vaccine is preventing one from acquiring new infections. We will therefore not administer any vaccine in this trial, since we are only interested in the correct choice of drug at this stage. 90 healthy adults (both male and female) will be recruited for this purpose in Kilifi district.</p>\n
      • study_title<p align=\"JUSTIFY\" style=\"margin-bottom: 0in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>Plasmodium falciparum </i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\">infection.</font></font></p>\n
      • laymans_summary<p>\n LAY SUMMARY<br />\n Formal title: Comparing drug-regimens for clearing parasites in Phase IIb trial designs prior to PCR monitoring for Plasmodium falciparum infection<br />\n <br />\n Lay Title: A study to compare how three different anti-malarial drug regimens can clear parasites from the blood.<br />\n <br />\n What is the background?<br />\n Malaria is a leading cause of illness and deaths in Africa. A malaria vaccine is therefore still a high priority for malaria control in Kenya as well as other African countries.<br />\n We want vaccines to protect children, but for reasons of safety prefer to test them in adults first.  Adults in Kenya and other African countries are usually immune to malaria.  This immunity prevents them from becoming unwell, but even though healthy adults do not become unwell they nevertheless have low levels of malaria parasites in their blood.<br />\n <br />\n In order to find out if new malaria vaccines are working, scientists can use the following design after recruiting adults as trial participants; a) treating the trial participants with anti-malarials so as to clear any parasites that may be present in blood, b) administering the experimental vaccine, then c) following the trial participants with repeated blood tests to look for low-level malaria infections.  If the vaccine is working well it should be able to prevent new malaria infections.<br />\n <br />\n This study aims at determining the best anti-malarial drug regimen that will be used in these trials to clear parasites before carrying out tests to check if a vaccine is preventing one from acquiring new infections. We will therefore not administer any vaccine in this trial, since we are only interested in the correct choice of drug at this stage.  <br />\n <br />\n In this study, we shall divide the participants into three groups and compare the groups so as to find out which anti-malarial regimen clears all malaria parasites in the blood fastest and doesn’t have many side-effects. The anti-malarial drugs that we will use in this trial have already been approved for use. People will be divided into the groups using a system based on chance without any preference, such that everyone has the same chance of being in either group. We hope to include 90 healthy adults (men and women) with 30 in each malaria treatment group.<br />\n <br />\n What questions are we trying to answer?<br />\n <br />\n We wish to compare the ability of 3 different anti-malarial treatments to clear malaria parasites in the blood without persisting in the body after completion of treatment. We also wish to assess the side effects associated with the various anti-malarial treatments so as to find the one with the least side effects.<br />\n <br />\n Where is the study taking place, how many people does it involve, and how are they selected?  <br />\n <br />\n The study will be done in Kilifi district and will involve 90 healthy adult male and female volunteers aged between 18 and 50 years.<br />\n  <br />\n <br />\n What does the study involve for those who are in it?  <br />\n Following attainment of all the necessary approvals (Scientific, Ethical and Regulatory), community engagement process will begin with contact with the district health management team then other local administrative and community leaders within the catchment area. Public meetings will then be arranged in the study villages to inform the communities of the planned study then individuals will be invited to the informed consent process.<br />\n <br />\n Those willing to take part will have a health check to ensure they can take part in the study which will also include a 15ml venous blood sample. Those recruited into the study will be divided into 3 groups and will receive anti-malrial treatment as follows strating from day 0(day of enrollment); 1) Atovaquone/proguanil + Artesunate (3 days) 2) Artesunate (7 days) or 3) S/P + Artesunate + Primaquine. The clinic attendances will range from 27 to 30 depending on whether one will be on a 3 day or 7 day anti-malarial course clinic attendances will be a total of 25 blood sampling occasions. After enrollment, blood samples will be taken as follows; 3 times a week for 4 weeks, followed by twice weekly for 3 weeks and finally once weekly for 6 weeks. All these blood samples will be 1ml in volume except on day 44 and day 90 when a 5ml blood sample will be drawn.<br />\n <br />\n There shall be a field worker home visit in the course of the study to assess bed net usage. Pregnant and lactating women will be excluded from this trial. A pregnancy test will be done during screening, on the day of enrollment (day 0) and on day 7. This is because some anti-malarial drugs are not safe during pregnancy. It is however safe to become pregnant after the completion of the anti-malarial treatment.<br />\n <br />\n What are the benefits and risks of the study for those involved?  <br />\n No direct payments will be gained from participating in this study.<br />\n Participants will receive medical care for acute illness from the day of the first dose of vaccine until the completion of the study at no cost. This study will involve taking time off work and travel costs for participants. Participants will however be compensated for their time spent off their routine work to be in this study, for each clinic visit at a level commensurate with the lost wages as well as travel costs.<br />\n  <br />\n As with any other medication, some side effects may be seen with this malaria medication. These include nausea and vomiting, abdominal pain, headache and loss of appetite. One of the anti-malarials in this trial is known to decrease the amount of blood in the body for those whose liver is not able to break it down. However, we shall test all volunteers prior to administering the anti-malarial drugs and will not administer this anti-malarial to anyone whose liver is not able to break it down as well as not enrol anyone with abnormal liver function.<br />\n There may be some pain and bruising associated with blood drawing which will resolve after a few days. There is a small risk of infection. This risk is minimized by use of pre packaged sterile equipment and trained staff.<br />\n  How will the study benefit society?<br />\n This study is justified by the high incidence of malaria mortality and morbidity in Kenya and the rest of sub-Saharan Africa. While other malaria control measures are in place, they are still not able to eliminate malaria. A vaccine may provide that last effort to malaria control.  Anti-malarial drugs may be used in various malaria vaccine trials to clear parasites before assessing if one is acquiring new infections after vaccination.<br />\n <br />\n When does the study start and finish?<br />\n This study is planned to start early in the 3rd quarter of 2013 and will run for 6 months.<br />\n <br />\n  </p>\n
      • short_titleMalPaC Trial
      • protocol_noECCT/13/08/02
      • version_no1.1
      • date_of_protocol29-04-2013
      • study_drug1) Atovaquone/proguanil + Artesunate 2) Artesunate or 3) S/P + Artesunate + Primaquine.
      • disease_conditionMalaria
      • 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_name1) Atovaquone/proguanil + Artesunate 2) Artesunate or 3) S/P + Artesunate + Primaquine.
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressctfuser@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • 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_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantCAROLINE OGWANG
      • declaration_date112-08-2013
      • declaration_principal_investigatorJUDY PESHU,PROJECT COORDINATOR
      • declaration_date212-08-2013
      • placebo_presentNo
      • study_objectives<p>\n General Objective<br />\n To evaluate three different drug regimens for use in a Phase IIb trial design that will eventually be used to test vaccine efficacy.<br />\n  <br />\n Specific Objectives<br />\n Primary objective<br />\n There are two co-primary objectives<br />\n <br />\n a)    To examine the proportion of participants positive by PCR 7 days following treatment with 3 different anti-malarials.<br />\n b)    To examine the proportion of participants positive by PCR on days 9 to 90 following treatment with 3 different anti-malarials.<br />\n <br />\n Secondary objectives<br />\n To assess whether low-level PCR positive results are live parasites as indicated by transcription of RNA (detected by Reverse Transcriptase- Polymerase Chain Reaction (RT-PCR)).<br />\n <br />\n To assess the tolerability of 3 different anti-malaria drug regimens used to clear malaria infection prior to PCR monitoring in adults.<br />\n <br />\n To assess the association between exposure to malaria as determined using serological responses to malaria antigens at the start and end of monitoring.<br />\n <br />\n To assess associations between pre-treatment frequencies of atypical memory B cells (as well as other B-cell phenotypes) with sero-conversion to malaria antigens upon re-infection during follow up.<br />\n <br />\n <br />\n  </p>\n
      • principal_inclusion_criteria<p>\n <u>Inclusion Criteria</u></p>\n<ul>\n <li>\n Consenting adults aged 18 – 50 years in good health.</li>\n <li>\n Will remain resident in the study area for the study duration.</li>\n <li>\n Able and willing (in the Investigator’s opinion) to comply with all study requirements</li>\n <li>\n Informed Consent</li>\n</ul>\n<p>\n <br />\n  </p>\n
      • principal_exclusion_criteria<p>\n <u>Exclusion criteria </u></p>\n<p>\n Any of the following constitutes exclusion criterion:</p>\n<ul>\n <li>\n Any significant medical disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.</li>\n <li>\n Haemoglobin less than 11.3 g/dl for men and less than 10g/dl for in women, where judged to be clinically significant in the opinion of the investigator.</li>\n <li>\n Blood transfusion within the month preceding enrolment.</li>\n <li>\n Current participation in another clinical trial or recent participation within 12 weeks of this study.</li>\n <li>\n Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.</li>\n <li>\n Pregnant or lactating women.</li>\n <li>\n Women unwilling to use contraception for the duration of drug treatment.</li>\n <li>\n Likelihood of travel away from the study area</li>\n</ul>\n<p>\n <u>Withdrawal criteria</u></p>\n<p>\n Subjects may be withdrawn from the study:</p>\n<ul>\n <li>\n By withdrawing consent</li>\n <li>\n On the decision of the investigator</li>\n</ul>\n<p>\n The investigator may withdraw the subject for the following reasons:</p>\n<ul>\n <li>\n Any adverse event which results in the inability to comply with study procedures</li>\n <li>\n Ineligibility either arising during the study or retrospectively</li>\n <li>\n Significant protocol deviation.</li>\n <li>\n Loss to follow up (applies to a subject who consistently does not return for protocol study visits, is not reachable by telephone or any other means of communication and/ is not able to be located).</li>\n</ul>\n
      • primary_end_points<p align=\"JUSTIFY\" style=\"text-indent: 0.5in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">We will compare drug regimens for time to first episode of </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>P.falciparum</i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\"> infection, defined as 2 or more consecutive blood samples </font></font></p>\n<p align=\"JUSTIFY\" style=\"text-indent: 0.5in; line-height: 100%\">\n <font face=\"Times New Roman, serif\"><font size=\"3\">confirmed positive by PCR, for </font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><i>P.falciparum.</i></font></font><font face=\"Times New Roman, serif\"><font size=\"3\"><u><b> </b></u></font></font></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:213px;\">\n Key investigators</td>\n <td style=\"width:213px;\">\n Qualification</td>\n <td style=\"width:213px;\">\n Experience</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n <td style=\"width:213px;\">\n  </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Caroline Ogwang</td>\n <td style=\"width:213px;\">\n MBChB</td>\n <td style=\"width:213px;\">\n Has been the lead clincian in a number of vaccine trials and has also been involved in drug trials.</td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Britta Urban   </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Phd in immunology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience immunological work and analysis both interenally and externally.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Domtila Kimani</p>\n </td>\n <td style=\"width:213px;\">\n <pre>\nMSc in immunology</pre>\n <p>\n  </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work and analysis in several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Jedidah Mwacharo                             </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Bsc in Science</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has experience in immunological work and analysis in several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Jimmy Shangala         </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n BPharm</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in IMP management for drug and vaccine trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Patricia Njuguna                                </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Mmed in Paediatrics</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Philip Bejon</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Phd in vaccinology</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Has vast experience in overseeing clinical trials and trial design both internally and externally. Has great experience in immunological work.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n <p>\n Ken Awuondo                                      </p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Msc in Biomedical science</p>\n </td>\n <td style=\"width:213px;\">\n <p>\n Is an experienced lab manager and has overseen sampla analysis for several trials.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:213px;\">\n Judy Peshu</td>\n <td style=\"width:213px;\">\n Registered Community Nurse</td>\n <td style=\"width:213px;\">\n Has vast experience in co-ordinating clinical trials.</td>\n </tr>\n </tbody>\n</table>\n<p>\n Others include field workers, a data clerk, a data manager, lab technicians and a pharmacy technician.</p>\n<p>\n The trial site has drugs for managing adverse events. Any participant requiring specilaist care will be reffered to Kilifi District Hospital.</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n N/A</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration6 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaJunju
      • single_site_physical_addressJunju Dispensary
      • single_site_contact_personCaroline Ogwang
      • single_site_telephone+(254) 417 522043
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site90
      • total_participants_worldwide90
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameCaroline
      • investigator1_middle_nameAmolo
      • investigator1_family_nameOgwang
      • investigator1_qualificationMedical Officer, MBChB
      • investigator1_professional_addressPO Box 230-80108, Kilifi, Kenya
      • investigator1_telephone+254 41 7522 063
      • investigator1_emailcogwang@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants90
      • notification
      • approval_date29-07-2013
      • 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_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-08-17 10:35:44
      • created2013-06-27 10:38:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id101
        • application_id158
        • given_nameCaroline
        • middle_nameAmolo
        • family_nameOgwang
        • qualificationMedical Officer, MBChB
        • professional_addressPO Box 230-80108, Kilifi, Kenya
        • telephone+254 41 7522 063
        • emailcogwang@kemri-wellcome.org
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
      • 1(array)
        • id103
        • application_id158
        • given_nameFrancis
        • middle_nameMaina
        • family_nameNdung\'u
        • qualificationPhD Immunology
        • professional_addressPO Box 230-80108, Kilifi, Kenya
        • telephone+254 41 7522 063
        • emailfndungu@kemri-wellcome.org
        • created2013-06-27 11:44:05
        • modified2020-08-17 10:35:44
    • SiteDetail(array)
      • 0(array)
        • id128
        • application_id158
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id82
        • application_id158
        • sponsorKEMRI Wellcome Trust Research Programme
        • sponsor_typeResearch Institution
        • contact_personDr Philip Bejon
        • addressKEMRI Wellcome Trust Research Programme
        • telephone_number+254 41 7522 063
        • fax_number
        • cell_number+254708587210
        • email_addresspbejon@kemri-wellcome.org
        • created2013-06-27 10:49:32
        • modified2020-08-17 10:35:44
  • 3(array)
    • Application(array)
      • id175
      • user_id60
      • trial_status_id5
      • abstract_of_study<p>\n <br />\n The burden of Mycobacterium tuberculosis (Mtb) disease, particularly when compounded by Human Immunodeficiency virus (HIV)-infection and the emergence of multi-drug resistant (MDR) and extensively-drug resistant strains (XDR), is significant in TB endemic countries/regions. In 2010, approximately 40% of TB cases were reported in India and China, of which up to 80% were pulmonary in nature [WHO, 2011]. Africa accounted for a further 24% of cases (of which 25% were in South Africa), with most cases in young adults. Prevention of TB disease is not only preferable to treatment of the disease for public health reasons, but an effective prophylactic TB vaccine would also lead to a considerable return in health benefits.<br />\n  </p>\n<p>\n This Phase IIb study is designed to evaluate the protective efficacy of the M72/AS01 E candidate tuberculosis vaccine<br />\n against definite pulmonary TB disease not associated with HIV-infection, versus placebo, following 2 injections given one month apart. The protective efficacy will be evaluated in adults living in a TB endemic region aged 18-50 years, i.e. in an age range where the incidence of tuberculosis is high.<br />\n  </p>\n<p>\n This study is an international, multicentre, phase IIb, double- blind, randomized, controlled trial. There will be follow-up for efficacy for approximately 3 years after vaccination via regular visits or contacts to screen for possible TB. Subjects will also be asked to recognise signs and symptoms compatible with TB disease and to self-report for clinical evaluation. Subjects with clinical suspicion of pulmonary TB will be assessed with confirmatory diagnostic testing using a Nucleic Acid Amplification Test (Xpert MTB/RIF assay, Cepheid) and microbiological culture. Subjects diagnosed with TB will be referred for TB treatment according to local clinical practice.</p>\n<p>\n <br />\n The primary objective of this study is to evaluate the protective efficacy of two doses of the M72/AS01 E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, as compared to placebo. To minimize the HIV prevalence in the study population at baseline, HIVtesting will be performed at screening in regions with a high HIV prevalence (> 1%). Additionally, when a subject isdiagnosed with TB, an HIV test (and pre-test counselling) will be performed to rule out HIV co-infection. When a subject isdiagnosed with HIV at the time of TB diagnosis, additional tests will be performed to measure CD4 cell counts to assessthe severity of the infection and decide on the appropriate treatment regimen. HIV-positive subjects will be referred for HIV treatment according to local clinical practice. Participating sites will use standardised case definitions for efficacy endpoints and a structured approach to case- assessment as outlined in this study protocol will be used. An Independent Data Monitoring Committee (IDMC) will be constituted for this study to perform periodic safety reviews of the safety data and evaluate the interim efficacy analysis<br />\n  </p>\n<p>\n A sub-cohort of subjects will be selected for specific follow- up for safety (solicited adverse events [AE] and selected Biochemistry and Complete Blood Count [CBC]) and immunogenicity. Unsolicited AEs, serious adverse events (SAEs), potential immune-mediated diseases (pIMDs), AEs leading to withdrawal and pregnancies will be recorded for all subjects. An IFN- positive T cell response induced by past or present Mtb infection, as measured by the QuantiFERON® TB Gold (QFTG) assay (Cellestis), will be evaluated at baseline for all subjects, at study end (Year 3) for all subjects QFTG-negative at baseline and yearly for subjects in the safety and immune sub-cohort. In addition, a QFTG assay will be performed whenever a subject isdiagnosed with TB disease.</p>\n
      • study_title<p>\n A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals’ candidatetuberculosis (TB) vaccine GSK 692342 against TB disease, in healthy adults aged 18-50 years, living<br />\n in a TB endemic region.</p>\n
      • laymans_summary<p>\n Kenya is 10th among the 22 countries with the highest burden of TB (WHO 2010) BCG is currently the only licensed TB vaccine. It reduces risk of severe forms of TB, but protection against pulmonary TB is incomplete. An effective prophylactic TB vaccine is needed. Seven thousand healthy, HIV negative adults in TB endemic regions will be randomised 1:1 to receive two identical doses M72/AS01E or placebo. Through a 36 month follow up period, initial efficacy, further safety and immunogenicity data on M72/AS01E vaccine will be accrued. The outcome of this phase IIb trial will determine whether the candidate advances to phase III licensure trials</p>\n
      • short_titleM72/AS01 E
      • protocol_noECCT/13/08/01
      • version_noAmendment 4
      • date_of_protocol29-03-2013
      • study_drugM72/AS01 E
      • disease_conditionTuberculosis
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvnduba@kemricdc.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample0
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr.Videlis Nduba
      • declaration_date106-08-2013
      • declaration_principal_investigatorNot Applicable
      • declaration_date206-08-2013
      • placebo_presentYes
      • study_objectives<p>\n <strong>Primary Efficacy Objective</strong>: To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against definite pulmonary TB disease, meeting the first case definition, as compared to placebo.</p>\n<p>\n <strong>Safety objective</strong>: To assess the safety and reactogenicity of two doses of the M72/AS01E candidate vaccine</p>\n<p>\n <strong>Immunogenicity objective</strong>: To assess the immunogenicity of two doses of the M72/AS01E candidate vaccine.</p>\n
      • principal_inclusion_criteria<p>\n All subjects must satisfy ALL the following criteria at study entry:</p>\n<ul>\n <li>\n  Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).</li>\n <li>\n A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.</li>\n <li>\n Written (or thumb printed and witnessed) informed consent obtained from the subject.</li>\n <li>\n Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination.</li>\n <li>\n Female subjects of non-childbearing potential may be enrolled in the study.</li>\n <li>\n Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause *</li>\n <li>\n Female subjects of childbearing potential may be enrolled in the study, if the subject:</li>\n <li>\n Has practiced adequate contraception* for 30 days prior to vaccination, and</li>\n <li>\n Has a negative pregnancy test on the day of screening and the day of first vaccination, and</li>\n <li>\n Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:</p>\n<ul>\n <li>\n Current TB disease or TB treatment within the last 12 months.</li>\n <li>\n Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.</li>\n <li>\n Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose ofvaccine.</li>\n <li>\n History of previous administration of experimental Mtb vaccines.</li>\n <li>\n Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone ≥ 20 mg/day or equivalent.). Inhaled and topical steroids are allowed.</li>\n <li>\n Any condition or illness (acute, chronic or history) or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.</li>\n <li>\n Any confirmed or suspected immunosuppressive or immunodeficient condition,  based on medical history and physical examination (no laboratory testing required).</li>\n <li>\n Documented HIV-positive subject*.HIV testing and pre-test counselling will be performed in areas with high prevalence of HIV (> 1%).</li>\n <li>\n Planned participation or participation in another experimental protocol during the study.</li>\n <li>\n Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).</li>\n <li>\n Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.</li>\n <li>\n History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.</li>\n <li>\n History of medically confirmed autoimmune disease.</li>\n <li>\n Pregnant or lactating female</li>\n</ul>\n
      • primary_end_points<p>\n <strong>Primary endpoint</strong><br />\n ï‚·     Incident cases of Definite Pulmonary TB disease not associated with HIV- infection, meeting the first case definition. Over a period starting 1 month post dose 2 and lasting up to 35 months post last vaccination.</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_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase II vaccine Trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The staff  who will work for this study is comprised of 3 medical officers (the study co-ordinator and the Principal Investigattor is also a medical officer), 6 clinical officers, 19 nurses, 14 community interviewers. These staff have a vast experience in the conduct of clinical trials having worked in an infant TB vaccine trial that is coming to an end The study will also be supported by a data department composed headed by a Senior data manager and comprises other data managers and data clerks, the QA section is comprised of the QA manager and QC officers whp together will take lead on quality issues of the study. The study will have a main pharmacy at the KEMRI CDC station in Kisumu with freezers and temperature monitoring devices. There is also a dispesing room at the study site, this dispensing room has a gas fridge and both the fridge and the room are temperature monitored.  The study has an equiped emergency tray at the site with anumber of staff trained on emergency procedures. Management of Serious Adverse events and adverse events will be done by a team of qualified and experienced medical personnel and those that require admissions are refered to the Siaya District Hospital. The study will use  the kEMRI-CDC malaria laboratory at Siaya District Hospital for safety assesments and other routine laboratory diagnosis. The TB laboratory at Kisian (that is in the process of accreditation) is used for TB diagncosis. The study also has access to an X-Ray facility at the siaya Distric Hospital.</p>\n
      • other_details_explanation<p>\n The country will be conducted in South Africa, Zambia and Kenya. Kenya is ranked 10 out of the 22 high burden countries globally, with an annual TB incidence of 298/100,000. Nyanza province contributes 20% of all reported cases nationally. The National TB control Program (NTP) reported for all types of TB an incidence rate of 7.17/1000 and 6.26/1000 in 2010 and 2011 respectively in the Lesser Siaya district consisting of 3 divisions (Karemo, Boro and Uranga).  The smear positive incidence rate was 1.93/1000 and 1.92/1000 in 2010 and 2011 respectively.</p>\n<p>\n The high prevalence and incidence of TB is driven by a high prevalence of HIV (15-25% of the adult population). About 72% of all reported TB cases tested are HIV co infected.</p>\n<p>\n BCG is the only licensed TB vaccine. It’s known to be effective against severe forms of TB, however confers only variable protection against adult onset Pulmonary TB among vaccinated persons. Development of an efficacious prophylactic vaccine is therefore a key element of successful TB control.</p>\n<p>\n M72/AS01 is an adjuvanted, fusion protein, TB vaccine candidate developed by GSK biologicals, designed to provide protective immunity against TB disease.  (Details of the product and previous human and preclinical studies are listed in the investigator brochure (IB)</p>\n<p>\n This phase IIb trial aims to collect preliminary efficacy data, and further safety, immunogenicity data on M72/AS01E, in healthy adults living in an endemic area.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 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_stateYes
      • location_of_areaKEMRI-CDC
      • single_site_physical_addressOff Busia Road
      • single_site_contact_personDr Videlis Nduba
      • single_site_telephone+254724522474
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites
      • multi_country_listSouth Africa and Zambia
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAminimum of 750 and a maximum of 1000
      • total_participants_worldwide4500
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_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_nameDr Grace
      • investigator1_middle_nameKiringa
      • investigator1_family_nameKaguthi
      • investigator1_qualificationMBCHB
      • investigator1_professional_addressKEMRICDC. PO BOX 1756, 40100. Kisumu, Kenya
      • investigator1_telephone+254729489743
      • investigator1_emailGkiringa@kemricdc.org
      • organisations_transferred_Yes
      • number_participants1000
      • notification<p>\n None</p>\n
      • approval_date06-08-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted25-07-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-09-10 17:54:32
      • created2013-07-19 11:56:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id113
        • application_id175
        • given_nameDr Videlis
        • middle_name
        • family_nameNduba
        • qualificationMBCHB
        • professional_addressKEMRICDC. PO BOX 1756, 40100. Kisumu, Kenya
        • telephone+25472522474
        • emailVnduba@kemricdc.org
        • created2013-07-19 12:05:53
        • modified2020-07-25 09:50:08
    • SiteDetail(array)
      • 0(array)
        • id142
        • application_id175
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-07-19 12:05:53
        • modified2020-07-25 09:50:08
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id89
        • application_id175
        • sponsorGlaxoSmithKline Biologicals
        • sponsor_typeIndustry
        • contact_personPaul Gillard
        • addressRue de l’Institut 89, 1330 Rixensart, Belgium
        • telephone_number+32 485 416 592/
        • fax_number
        • cell_number +32 10 85 4778
        • email_addressPaul.gillard@gsk.com
        • created2013-07-19 12:05:53
        • modified2020-07-25 09:50:08
  • 4(array)
    • Application(array)
      • id201
      • user_id89
      • trial_status_id(null)
      • abstract_of_study<div>\n Visceral leishmaniasis is a systemic disease that is fatal if left untreated and worldwide</div>\n<div>\n causes an estimated 50,000 deaths annually. In East Africa Visceral leishmaniasis</div>\n<div>\n frequently causes large-scale tenacious epidemics with high case-fatality rates (CFRs).</div>\n<div>\n For most of the past 70 years, the therapeutic armoury for treatment of leishmaniasis has</div>\n<div>\n been extremely limited. Pentavalent antimonials were introduced in the 1940s. Use of</div>\n<div>\n amphotericin B followed after a few decades, and was later joined by paromomycin, a</div>\n<div>\n cheap and effective parenteral drug with an acceptable toxicity profile that can easily be</div>\n<div>\n given by intramuscular injection. Finally, different lipid formulations of amphotericin B</div>\n<div>\n (i.e. liposomal amphotericin B , Ambisome ) have been developed, which are similar to</div>\n<div>\n amphotericin B in efficacy but with fewer toxic effects.</div>\n<div>\n The development of miltefosine, the only drug at present that can be given orally for the</div>\n<div>\n treatment of visceral leishmaniasis, has been a major breakthrough. Dafra Pharma</div>\n<div>\n Research and Development intends to develop and commercialize a new and promising</div>\n<div>\n alkylphosphocholine, oleylphosphocholine (OlPC), which is a derivative of miltefosine as</div>\n<div>\n a new oral drug for the treatment of leishmaniasis.</div>\n<div>\n The chemical structures of two alkylphosphocholines, oleylphosphocholine and</div>\n<div>\n miltefosine are as shown below. The key difference between the two</div>\n<div>\n alkylphosphocholines is that OLPC has a double bond in the alkyl chain that miltefosine</div>\n<div>\n does not have.</div>\n<div>\n  </div>\n<div>\n <div>\n Oleylphosphocholine presents an efficacy profile similar or superior to the one of</div>\n <div>\n miltefosine in various experimental models, but has the advantage of showing a wider</div>\n <div>\n therapeutic window compared to miltefosine translating into a better tolerance and</div>\n <div>\n possible increased compliance to treatment, but it has not been administered to human in a</div>\n <div>\n controlled clinical study.</div>\n</div>\n<div>\n Objectives</div>\n<div>\n The primary objective is to estimate initial safety and tolerability of oleylphosphocholine</div>\n<div>\n in healthy male volunteers.</div>\n<div>\n The secondary objective is to obtain data on pharmacokinetics following oral</div>\n<div>\n administration of oleylphosphocholine in human.</div>\n<div>\n Methods</div>\n<div>\n This protocol is intended to evaluate whether a rising dose of oleylphosphocholine,</div>\n<div>\n administered orally in fasting condition, is well tolerated and safe in man. The protocol</div>\n<div>\n uses 3 cohorts of 10 volunteers receiving a dose of 50, 100 or 150mg (on Day 0) of</div>\n<div>\n oleylphosphocholine randomly allocated to the participants. The volunteers will also be</div>\n<div>\n sampled for pharmacokinetic purposes.</div>\n<div>\n Utility of results</div>\n<div>\n This protocol is made for a first in man study of the compound oleylphosphocholine.</div>\n<div>\n Single dose escalating, open Phase 1 trial in healthy male volunteers to evaluate the</div>\n<div>\n safety, tolerability and the pharmacokinetics of oleylphosphocholine. The drug is</div>\n<div>\n developed to become a treatment for Leishmaniasis in Africa. The results are intended to</div>\n<div>\n be used to develop a phase-II study on the study.</div>\n<div>\n In case the criteria for halting the study are not met at the end of the study, i.e. after all 30</div>\n<div>\n volunteers have received their allocated study dose, tolerability beyond the intended</div>\n<div>\n therapeutic dose might be explored to gain experience regarding target organs of toxicity</div>\n<div>\n in case of intoxication during clinical use, or to allow higher doses for Phase II studies, if necessary.</div>\n<div>\n  </div>\n
      • study_title<p>\n Single Dose Escalating, Single-blind Phase 1 Trial in Healthy Male Volunteers to Evalute the Safety, Tolerability and the Pharmacokinetics of Oleylphosphocholine.</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/07/05
      • version_no12
      • date_of_protocol24-06-2013
      • study_drugOleyphosphocholine
      • disease_conditionNA
      • 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_nameOleyphosphocholine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssnjoroge@kemri.org
      • applicant_covering_letter1
      • applicant_protocol1
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      • applicant_opinion_letter1
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      • declaration_applicantDr. Njenga S. Njoroge
      • declaration_date105-08-2013
      • declaration_principal_investigatorDr. Rashid Juma
      • declaration_date205-08-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n Healthy male, adults aged 18-45 years inclusive at the time of screening</li>\n <li>\n Weight between 45-80 Kg inclusive</li>\n <li>\n Written informed consent obtained from the participants before study start</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n HIV positive or other immunosuppresive status</li>\n <li>\n Symptomatic infection</li>\n <li>\n concomitant exposure to other investigational medicinal products</li>\n <li>\n History of alcohol or drug abuse</li>\n <li>\n Known hypersensitivity to miltefosine</li>\n <li>\n Lipid disorders, including abnormal blood levels of total cholesterol, HDL,LDL and triglycerides</li>\n <li>\n Laboratory result abnormalities including abnormal ECG, liver function tests more than three times upper limit of normal, creatinine outside normal range</li>\n <li>\n Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurologic condition or any other finding that in the opinion of the PI may increase the risk to the participant from participating in the study</li>\n <li>\n Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Identify potential dose limiting toxicity of OIPC</li>\n <li>\n Documentation of solicited symptoms after administration during a 29 day follow-up period, i.e from day 0 (day of administration) to day 28 post-administration</li>\n <li>\n Documentation of unsolicited symptoms after administration during a 29-day follow up period i.e from day 0 (day of administration) to day 28 post administration</li>\n <li>\n Documentation of the occurance of serious adverse events (SAE) throughout the study period</li>\n <li>\n Determination of the serum levels of oleylphosphocholine following oral administration.</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • 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_controlledNo
      • site_capacity(null)
      • staff_numbers<div>\n The Centre for Clinical Research (CCR) at KEMRI was established in 1983 and has since grown to</div>\n<div>\n an international centre for clinical research. The facilities consist of 30 clinical beds, 10 of which are</div>\n<div>\n dedicated to Phase 1 clinical trials.</div>\n<div>\n CCR has clinical laboratories for haematology, clinical biochemistry and parasitology. The centre</div>\n<div>\n also has a full-fledged radiology Unit as well as a facility for upper-GI and lower-GI endoscopy. The</div>\n<div>\n laboratory equipments are regularly maintained and serviced. All laboratories have SOPs for</div>\n<div>\n maintenance and for running the different tests.</div>\n<div>\n In terms of personnel the centre has 6 highly qualified doctors and a clinical officer. The laboratory</div>\n<div>\n has 10 highly qualified technical employees. There is also 1 radiologist, 3 radiographers and 17</div>\n<div>\n research nurses. A pharmacy and a qualified pharmacist are also present on site.</div>\n<div>\n This study team is highly experienced in conducting complex studies and complying with ICH/GCP</div>\n<div>\n requirements. All CCR scientific, nursing and laboratory staffs are GCP/GcLP trained, and biannually undergo GCP/GcLP refresher courses.</div>\n<div>\n The team of CCR has conducted several clinical trials including Phase 1 studies.</div>\n
      • other_details_explanation<div>\n Dafra Pharma distributes its products exclusively on the African market and has always</div>\n<div>\n focused on making drugs available for the African population, where the need is high and</div>\n<div>\n drugs need to be affordable. Therefore it is ethically fair that the African population and</div>\n<div>\n scientific community, who are likely to use the medicine in clinical practice, participate in</div>\n<div>\n the clinical development. This will allow reliable and accurate data about tolerance and</div>\n<div>\n pharmacokinetics to be compiled in the target population.</div>\n<div>\n Dafra Pharma is developing the investigational drug oleylphosphocholine (OlPC) as a</div>\n<div>\n new therapeutic treatment option for visceral leishmaniasis. This neglected parasitic</div>\n<div>\n disease does not occur in the country of the sponsor (Belgium), whereas it is endemic to</div>\n<div>\n Kenya. The goal of the current Phase I study is to assess the safety and pharmacokinetic</div>\n<div>\n profile of OlPC in healthy Kenyan volunteers.</div>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n NA</p>\n
      • estimated_durationSeven months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
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      • design_controlled_specify
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      • design_controlled_other_medicinal
      • design_controlled_placebo
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      • single_site_member_stateYes
      • location_of_areaKEMRI Centre for Clinical Research
      • single_site_physical_addressMbagathi way
      • single_site_contact_personDr. Njenga S Njoroge
      • single_site_telephone254 722 733 213
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site30
      • total_participants_worldwide30
      • 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_female0
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
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      • subjects_nursing_womenNo
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      • subjects_incapable_consentNo
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      • subjects_others_specify
      • investigator1_given_nameDr. Rashid
      • investigator1_middle_nameRavasco
      • investigator1_family_nameJuma
      • investigator1_qualificationMedical Doctor
      • investigator1_professional_addressKEMRI Centre for Clinical Research
      • investigator1_telephone254 20 2726781
      • investigator1_emailjrashid@kemri.org
      • organisations_transferred_No
      • number_participants30
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      • approval_date25-06-2013
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      • date_submitted06-08-2013
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      • balance_site(null)
      • final_date(null)
      • modified2013-08-14 16:45:05
      • created2013-08-05 15:07:05
      • total_sites(null)
      • ecitizen_invoice(null)
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        • emailjrashid@kemri.org
        • created2013-08-05 15:16:05
        • modified2013-08-06 13:31:23
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        • sponsorDafra Pharma Research and Development
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        • contact_personBruno Jansen
        • addressSlachthuisstraat 30/7, 2300 Turnhout, Belgium
        • telephone_number+32 14 47 29 98
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        • cell_number+32 475 422 920
        • email_addressbruno.jansen@dafra.be
        • created2013-08-05 15:16:05
        • modified2013-08-06 13:31:23
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