A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 13
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR12)
研究概览
简要总结
The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Genotype 3 HCV
- •HCV RNA ≥10000 IU (International Unit)/mL
- •Compensated Liver Cirrhosis
- •BMI 18-40 kg/m2
- •Previously treated for HCV or never treated for HCV
排除标准
- •Infection with HCV other than Genotype
- •Mixed infection of any genotype
- •Evidence of decompensated liver disease
- •Previous exposure to NS5A inhibitors
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
干预措施: DCV (Drug)
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
干预措施: SOF (Drug)
Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)
Oral dosing of DCV 60 mg tablet once daily + SOF 400 mg tablet once daily + RBV 1000-1200 mg tablet per day (weight based) for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR12)
时间窗: Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.
次要结局
- Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24(At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24)
- Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24(At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks))
- Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms(Week 12 (Follow-up period))