A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
研究概览
简要总结
The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load of ≥10*5* IU/mL (100,000 IU/mL) at screening
- •Treatment naive
排除标准
- •Women of child-bearing potential
- •Cirrhosis
- •Coinfection with HIV or hepatitis B virus
研究组 & 干预措施
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
干预措施: Daclatasvir (Drug)
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
干预措施: Peginterferon alpha-2a (Drug)
Daclatasvir, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
干预措施: ribavirin (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
干预措施: Daclatasvir (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
干预措施: Peginterferon alpha-2a (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
干预措施: ribavirin (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
干预措施: Daclatasvir (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
干预措施: Peginterferon alpha-2a (Drug)
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
干预措施: ribavirin (Drug)
Placebo, Peginterferon alpha-2a, ribavirin (D)
干预措施: Placebo (Drug)
Placebo, Peginterferon alpha-2a, ribavirin (D)
干预措施: Peginterferon alpha-2a (Drug)
Placebo, Peginterferon alpha-2a, ribavirin (D)
干预措施: ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
时间窗: A Weeks 4 and 12
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
次要结局
- Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12(At Week 12)
- Percentage of Participants With Rapid Virologic Response (RVR) at Week 4(At Week 4)
- Percentage of Participants With Early Virologic Response (EVR) at Week 12(At Week 12)