A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
研究概览
简要总结
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia (defined as < 1% factor activity level)
- •Infection with the hepatitis C virus (HCV) with underlying hemophilia
- •Males 18 years of age and above
- •Have not been previously treated with an interferon
排除标准
- •Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Chronic liver disease caused by any disease other than chronic HCV infection
- •Presence of Bethesda inhibitor
- •Current evidence of or history of portal hypertension
研究组 & 干预措施
Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Pegylated-Interferon-lambda (Biological)
Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Ribavirin (Drug)
Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Daclatasvir (Drug)
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Pegylated-Interferon-lambda (Biological)
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Ribavirin (Drug)
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
时间窗: Follow-up Week 12
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
次要结局
- Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment(After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B))
- Percentage of Participants With Complete Early Virologic Response (cEVR)(Treatment Week 12)
- Percentage of Participants With Rapid Virologic Response (RVR)(Treatment Week 4)
- Percentage of Participants With End of the Treatment Response (EOTR)(End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B))
- Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities(After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B))
- Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)(Follow-up Week 24)
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death(From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B))
- Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment(After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B))