Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
研究概览
简要总结
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must have Genotype 3 Chronic HCV
- •Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
- •HCV RNA Viral load ≥ 10,000 IU/mL
- •HCV Treatment naive or treatment-experienced
排除标准
- •Non Genotype 3 or mixed genotypes
- •Non advanced fibrosis or compensated cirrhosis
- •Any prior treatment with NS5A inhibitors
研究组 & 干预措施
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Daclatasvir (Drug)
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Sofosbuvir (Drug)
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Ribavirin (Drug)
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Daclatasvir (Drug)
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Sofosbuvir (Drug)
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
时间窗: Follow-up Week 12
SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
次要结局
- Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities(Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group))
- Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)(Follow-up Weeks 4 and 24)