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Data Sheet of Clinical Trial C.T DATA SHEET OF CLINICAL TRIAL C.T. No 048-14 CLINICAL TRIAL REGISTRATION (EC) I. SPONSOR INFORMATION Foreign National 2. LEGAL PERSON 2.1 FOREIGN SPONSOR Registered Name: GlaxoSmithKline Registered Tradename: GlaxoSmithKline FOREIGN SPONSOR REPRESENTATIVE IN PERU SUBSIDIARY: BRANCH: CRO: OTHER: _________ Tradename: N/A TYPE OF INSTITUTION Laboratorio (Industria Farmacéutica) II. CLINICAL TRIAL GENERAL INFORMATION 1. CLINICAL TRIAL IDENTIFICATION Scientific Title: A RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, COMPARATIVE, MULTICENTER STUDY TO ASSESS THE INCIDENCE OF HEMOLYSIS, SAFETY, AND EFFICACY OF TAFENOQUINE (SB-252263, WR238605) VERSUS PRIMAQUINE IN THE TREATMENT OF SUBJECTS WITH PLASMODIUM VIVAX MALARIA Public Title: A RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, COMPARATIVE, MULTICENTER STUDY TO ASSESS THE INCIDENCE OF HEMOLYSIS, SAFETY, AND EFFICACY OF TAFENOQUINE (SB-252263, WR238605) VERSUS PRIMAQUINE IN THE TREATMENT OF SUBJECTS WITH PLASMODIUM VIVAX MALARIA Secundary ID(s): WHO UTN: PER-048-14 Protocol Code: TAF116564 Clinicaltrials.gov: NA EUDRACT N°: NA 1 1-2 2 2-3 Study clinical phase: 3 4 Clinical Trial Total Duration: 24 months No Aplica 0(exploratory trials) Enrolment start date in Peru (Initial) 30/12/2014 Worldwide enrolment start date (dd/ (dd/mm/aaaa): 18/09/2014 mm/aaaa): Enrolment start date in Peru (Posterior) (dd/mm/aaaa): Without starting enrollment In enrollment Peru enrolment status : Enrollment stopped Enrollment closed Other 2. CLINICAL TRIAL GOALS AND DESIGN Randomnized Simple Non randomnized Double Assignation method Type of blinding No aplica Triple Open Single arm Parallel Crossed Factorial Assignation Others: ____________________ Study Design In this prospective, double-blind, double-dummy design, a total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate G6PD deficiency (&#8805;40% - <70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects must remain in the hospital for a minimum of the first 3 days of the study to monitor study medication compliance and infection status, and will continue on treatment as an outpatient for an additional 12 days. Subjects will be monitored up to day 29 for recrudescence, then continue to be monitored up to 180 days post-randomization for evidence of relapsing infection. Purpose • To investigate the occurrence of clinically relevant hemolysis in adult subjects with P. vivax. The incidence of hemolysis in the subgroup of female patients with moderate (40-70%) G6PD activity is of particular interest. Página 1 de 4 3. STUDY INTERVENTION Indicate if the product is being developed as: Pharmaceutical product Medical device Herbal product Type of research product Galenic product Complementary product Dietary product and sweetener Other: ____________________ Research product identification N° Product name Generic name Product type ATC 1 Tafenoquina/Placebo Tafenoquina/Placebo Producto en investigación de origen P01 - Antiprotozoarios químico N° Comparator name Generic name Product type ATC 1 Primaquina Primaquina Medicamento P01 - Antiprotozoarios Intervention(s) description: N° of Group Name Type of group Intervention(s) description participants Subjects' treatment time 15 days Subjects' follow up time 165 days 4. Study Population Inclusion Criteria: 1. 1 A female is eligible to enter and participate in the study if she is non-pregnant, non-lactating and if she is of: a. Non-childbearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or <6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL), or pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation, negative pregnancy test or, b. Child-bearing potential, has a negative pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study medication 2.The subject has a glucose 6-phosphate dehydrogenase (G6PD) value (measured by a quantitative spectrophotometric phenotype assay) as follows: • Female subjects must have an enzyme level &#8805;40% of the site median value for G6PD normal males. • Male subjects must have an enzyme level &#8805;70% of the site median value for G6PD normal males. 3. The subject has a screening hemoglobin (Hb) value as follows: •Any subject with a G6PD value &#8805;70% of the site median value must have a screening Hb value &#8805;7 g/dL. •Female subjects with a G6PD value is &#8805;40% - <70% of the site median value must have a screening Hb value &#8805;8 g/dL 4.The subject has a QTcF of <450 msec N.B. Reading based on an average of triplicate ECGs obtained over a brief recording period by machine or manual over-read 5.The subject has a positive malarial smear for P. vivax Exclusion Criteria: 1. 1. The subject has a mixed malaria infection (identified by a malarial smear or rapid diagnostic test). 2. The subject has severe P. vivax malaria as defined by WHO criteria. 3. The subject has a history of allergy to chloroquine, mefloquine, tafenoquine, primaquine, or to any other 4- or 8-aminoquinoline 4. The subject has a liver ALT >2 x ULN. 5. The subject has severe vomiting (no food or inability to take food during the previous 8 hours). 6. The subject has a clinically significant concurrent illness (e.g., pneumonia, septicemia), pre-existing condition (e.g., renal disease, malignancy), condition that may affect absorption of study medication (e.g., vomiting, severe diarrhea), or clinical signs and symptoms of severe cardiovascular disease (e.g., uncontrolled congestive heart failure, severe coronary artery disease). 7. The subject has a history of porphyria, psoriasis, or epilepsy. 8. The subject has a history of significant ocular disease (e.g. surgery to the globe, glaucoma, diabetic retinopathy) or has evidence of corneal or retinal abnormalities identified in the clinical screening ophthalmologic examination. Studied Condition: N/A Studied Condition B51Plasmodium vivax malaria Medical speciality : Infectology classification(CIE-10): • Etiopia • Peru • Tailandia Countries where the enrolment is • Brasil • Camboya • Vietnam conducted: • Colombia • Filipinas Number of participants per gender 100 >Number of subjects to be included (Initial): 300 in all the countries: Number of participants per gender 0 (Posterior): Population to be included by gender Women Men Both Healthy volunteers Yes No Subordinate Groups Yes No Indigenous or native people Yes No Minors Yes No Indicate if the study population Subjects with disabilities to grant consent includes: Yes No Women of childbearing age Yes No Pregnant women Yes No Women during labor, puerperium or lactation Yes No Fetus Yes No Range of age of subjects to be Adults(18-64 years) Yes No included: Elderly (>= 65 years) Yes No Under 18 years Yes No Página 2 de 4 - In Utero Yes No - Preterm newborn infants (up to gestational age < 37 weeks) Yes No - Newborns (0-27 days) Yes No - Infants and toddlers (28 days-23months) Yes No - Children (2 - 11 years) Yes No - Adolescents (12 - 17 years) Yes No 5. EVALUATION CRITERIA Primary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement Secondary Evaluation Criteria N° Evaluation criteria name Method of measurement Time point for the measurement 6. DATA MONITORING Existence of the Data Monitoring ¿Interim analysis is planned? Yes No Committee(CMD) Yes No III. INFORMATION FROM THE FINANCING SOURCE 1. INFORMATION FROM THE FINANCING SOURCE Sponsor Name GlaxoSmithKline 2. Sponsor Responsibilities Institution Name Responsibility N/A Inform to the OGITT of the NIH when the first subject is enrolled in Peru, and the end date of enrollment in the country. N/A Submit progress reports to the National Health Institute during the execution of the Clinical Trial. N/A Submit to the OGITT of the NIH the final reports as well as the results, conclusions, and publication of the clinical trial. N/A Notify to the OGITT of the NIH the adverse events and deviations as established in the Clinical Trials Regulation. N/A Inform and describe the reasons for a suspension and cancellation of the clinical trial. N/A Provide the facilities for the inspection of the execution of the clinical trial by the staff of the General Office of Research and Technology Transfer (OGITT) of the National Institute of Health. N/A False IV. RESEARCH SITE, PRINCIPAL INVESTIGATOR, ETHICS COMMITTEE Research Site 1 of 1 1. RESEARCH SITE WHERE THE CLINICAL TRIAL WILL BE CONDUCTED CLINICA SELVA AMAZONICA - RCI N°: 00129 Research site: ASOCIACIÓN CIVIL SELVA AMAZÓNICA 2. PRINCIPAL INVESTIGATOR Full name: Elmer Alejandro, Llanos Cuentas 3. CO-INVESTIGATOR 4. INSTITUTIONAL RESEARCH ETHICS COMMITTEE (CIEI) THAT APPROVED THE TRIAL FOR THE SITE UNIVERSIDAD PERUANA CAYETANO HEREDIA - Comité Institucional de Ética en RCIEI N°: 00014 Ethics Committe Name: Investigación - CIEI de la Universidad Peruana Cayetano Heredia - UPCH Approval date: 19/06/2014 End approval date: 18/06/2015 CONTACT DATA (Legal Representative of CIEI) Full Name: Humberto Antonio, Guerra Allison E-mail: [email protected] Av. Honorio Delgado 430 Urb. I Telephone number: 3190000 anexo 2271 Address: (Lima - Lima - San Martin de Porres) VI. SHARED USE OF CLINICAL TRIAL DATA (ANONIMIZED INDIVIDUAL DATA) ¿Is there a plan for sharing of Yes No Not decided deidentified individual clinical trial participant-level data (IPD) to other researchers (including data dictionaries)? Página 3 de 4 In case the answer is affirmative, describe the Plan: None Study protocol Statistical Analysis Plan Informed consent form Additional information that will be Clinical Study Report shared Others _______________ (Inglés) Describe briefly when this information will be available and how it can be obtained. N/A URL N/A DOI N/A Clinical Trial Registration Date 13-11-2014 00:00 Most recent Clinical Trial Update N/A VII. CLINICAL TRIAL CONTACT PERSONS INFORMATION DATA OF THE CONTACT PERSON(s) FOR CONSULTATIONS ABOUT THE CLINICAL TRIAL Full Name Email Telephone Type of queries to be resolved VIII.
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