Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Sustained Viral Response (SVR12)
研究概览
简要总结
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- •Renal failure (eGFR < 30 cc/min) or under hemodialysis
排除标准
- •Model for End-stage Liver Disease (MELD) score > 20,
- •Child's C (CTP score > 12),
- •Heart rate < 50/min,
- •Taking amiodarone
研究组 & 干预措施
Sovodak
Sofosbuvir 400 mg and daclatasvir 60 mg
干预措施: Sofosbuvir 400 mg and daclatasvir 60 mg (Drug)
结局指标
主要结局
Sustained Viral Response (SVR12)
时间窗: 12 weeks after end of treatment
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
次要结局
- Safety as assessed by adverse drug events(From start of treatment to 12 weeks after end of treatment)