Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males and females, ≥ 18 years of age
- •Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
- •HCV RNA viral load ≥ 10,000 IU/mL
- •Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
- •Body Mass Index (BMI) of 18 to 35 kg/m2
- •Seronegative for Hepatitis C virus (HIV) and Hepatitis B
排除标准
- •Evidence of decompensated liver disease
- •Evidence of medical condition contributing to chronic liver disease other than HCV
研究组 & 干预措施
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Genotype 2/3 NR/relapse Subjects
干预措施: BMS-986094 (Drug)
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
干预措施: Daclatasvir (Drug)
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
干预措施: BMS-986094 (Drug)
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
干预措施: Placebo for BMS-986094 (Drug)
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)
干预措施: Daclatasvir (Drug)
Arm 2: Daclasasvir + BMS-986094 (200 mg)
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)
干预措施: BMS-986094 (Drug)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
干预措施: Daclatasvir (Drug)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
干预措施: BMS-986094 (Drug)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
干预措施: Ribavirin (Drug)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
干预措施: Placebo for BMS-986094 (Drug)
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
干预措施: Daclatasvir (Drug)
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
干预措施: BMS-986094 (Drug)
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
Subjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy)
Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
干预措施: Ribavirin (Drug)
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Genotype 1 PI-failure subjects
干预措施: Daclatasvir (Drug)
Arm 5: Daclasasvir + BMS-986094 (200 mg)
Genotype 1 PI-failure subjects
干预措施: BMS-986094 (Drug)
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Genotype 4 naive subjects
干预措施: Daclatasvir (Drug)
Arm 6: Daclasasvir + BMS-986094 (200 mg)
Genotype 4 naive subjects
干预措施: BMS-986094 (Drug)
Arm 7: Daclasasvir + BMS-986094 (200 mg)
Genotype 2/3 NR/relapse Subjects
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)
时间窗: Follow up Week 4
* SVR = Sustained virologic response * HCV = Hepatitis C virus * RNA = Ribonucleic acid * LOQ = Limit of quantitation
次要结局
- Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)(Follow up Week 4 (SVR4))
- Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)(Follow up Week 4 (SVR4))
- Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment(Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms))
- Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)(Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24))
- Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable(Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24))
- Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities(Up to post treatment Week 36)