RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response
研究概览
简要总结
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects chronically infected with HCV genotype 1a
- •HCV RNA ≥ 10,000 IU/mL at screening
- •Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)
排除标准
- •Evidence of cirrhosis
- •Liver or any other organ transplant
- •Current or known history of cancer within 5 years prior to enrollment
- •Documented or suspected hepatocellular carcinoma (HCC)
- •Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
研究组 & 干预措施
Arm 1
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks
干预措施: DCV/ASV/BMS-791325 (Drug)
Arm 2
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks
干预措施: DCV/ASV/BMS-791325 (Drug)
Arm 3
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks
干预措施: DCV/ASV/BMS-791325 (Drug)
Arm A
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks
干预措施: DCV/ASV/BMS-791325 + RBV (Drug)
Arm B
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks
干预措施: DCV/ASV/BMS-791325 + RBV (Drug)
Arm C
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks
干预措施: DCV/ASV/BMS-791325 + RBV (Drug)
结局指标
主要结局
Sustained Virologic Response
时间窗: Post treatment week 12
Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12
次要结局
- Sustained virologic response(2, 4 and 24 weeks post-treatment)
- Post treatment virologic response(post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24))
- Virologic failure(On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24)
- On treatment virologic response(On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12)
- Safety(Up to end of treatment (+7 days))
- Day 2 positive predictive value(Post treatment Week 12)
- Interferon lambda genotype and virologic response(On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24)
研究者
Timothy Morgan, MD
Chief, Hepatology
Southern California Institute for Research and Education