Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,448
- 试验地点
- 1
- 主要终点
- The sustained viral response rate
研究概览
简要总结
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.
详细描述
All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.
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
- 12 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
排除标准
- •Heart rate < 50/min,
- •Taking amiodarone
研究组 & 干预措施
Treatment
Subjects will receive sofosbuvir and daclatasvir
干预措施: sofosbuvir and daclatasvir (Drug)
结局指标
主要结局
The sustained viral response rate
时间窗: 12 weeks after end of treatment
Qualitative hepatitis C virus RNA polymerase chain reaction
次要结局
- Adverse drug events(weeks 2, 4, 8, 12 and 24)