NCT02739477终止2 期
Tolerance and Activity Assessment of High Doses of Favipiravir in Male Survivors With Ebola Virus in the Semen
Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
This study aims to evaluate favipiravir high dose tolerance in male survivor of Ebola Virus Disease (EVD) with Ebola Virus (EBOV) RNA in semen. This is a dose escalation study with 3 cohorts of 6 patients, each dose level including 2 sentinel patients.
详细描述
Rational:
- Data suggesting persistence of EBOV in semen a few months after the end of EVD and sexual transmission of EBOV
- Encouraging results on favipiravir efficacy to reduce mortality of EVD in JIKI trial (NCT02329054 )
- Favipiravir trough plasma concentration in JIKI trial lower than predicted by population pharmacokinetic model, suggesting an increase of dose might be necessary to achieve a therapeutically relevant exposure.
Objectives:
- Primary objective: to assess clinical and biological tolerance of high-dosed favipiravir bid for 14 days
- Secondary objectives: to assess the activity of favipiravir on evolution of EBOV RNA and infectious loads in semen under treatment; the trough plasma and semen concentrations of favipiravir; and genetic factors associated with favipiravir pharmacokinetic.
Dose escalation scheme:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
Favipiravir
Experimental
Favipiravir (oral administration, 200 mg light yellow, round-shaped, coated divisible tablets that can be crushed and mixed with liquid)
干预措施: Favipiravir (Drug)
结局指标
主要结局
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)
时间窗: Day 14
Day 1 is the first day of favipiravir intake
次要结局
- Genetic variations associated with favipiravir exposition(Blood collection at Day 1 will be used for further genotyping.)
- Evolution of EBOV semen RNA and infectious loads(Semen collection will be performed at least at Day 7, Day 14, Day 21 and Day 90)
- Plasma and semen trough concentrations of favipiravir(Plasma collection at Day 3, Day7, Day 10 and Day 14. Semen collection at Day 7 and Day 14)
研究者
研究点 (2)
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