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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02739477 |
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Date of registration:
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24/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tolerance and Activity Evaluation of High Doses of Favipiravir Against Ebola Virus in the Semen
FORCE |
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Scientific title:
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Tolerance and Activity Assessment of High Doses of Favipiravir in Male Survivors With Ebola Virus in the Semen |
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Date of first enrolment:
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April 2016 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02739477 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Guinea
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Contacts
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Name:
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Daouda Sissoko, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inserm 897 unit, ISPED, Université de Bordeaux, Bordeaux cedex |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male survivor of biologically confirmed EVD
- age >= 18 years
- EBOV RT-PCR on semen with cycle threshold [Ct]<38 at Day -7 and semen aliquot
available for later quantification of EBOV
- signed informed consent
Non-Inclusion Criteria:
- EBOV RT-PCR on blood with cycle threshold [Ct]<38 at Day -7
- Biological abnormality higher than grade 2 according to CTCAE (v4.03) on following
parameters: creatinine, ASAT, ALAT, alkaline phosphatase, total bilirubin
- Fridericia corrected QT interval (QTc) > 450 ms
- Concomitant use of QT/QTc interval-prolonging drugs or drugs that could cause
electrolyte imbalance, such as: loop diuretics, thiazide diuretics or related
- Previous gout attack or ongoing treatment for gout or hyperuricemia
- Ongoing pyrazinamide treatment or other drug known to induce hyperuricemia
- Previous hypersensitivity reaction due to nucleoside analogue
- Symptom or biological value suggesting systemic disorder (renal, hepatic,
cardio-vascular, pulmonary) or any medical condition that could interfere with results
interpretation or compromise participants' health
- Explicit refusal to comply with proper use of drug (condom use)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Ebola Virus Survivor
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Intervention(s)
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Drug: Favipiravir
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Primary Outcome(s)
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Number of patients undergoing grade 3 or 4 clinical or biological adverse events related to Favipiravir (Common Terminology Criteria for Adverse Events, CTCAE, v4.03)
[Time Frame: Day 14]
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Secondary Outcome(s)
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Genetic variations associated with favipiravir exposition
[Time Frame: Blood collection at Day 1 will be used for further genotyping.]
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Evolution of EBOV semen RNA and infectious loads
[Time Frame: Semen collection will be performed at least at Day 7, Day 14, Day 21 and Day 90]
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Plasma and semen trough concentrations of favipiravir
[Time Frame: Plasma collection at Day 3, Day7, Day 10 and Day 14. Semen collection at Day 7 and Day 14]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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