NCT01492426已完成3 期
A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Bristol-Myers Squibb26 个研究点 分布在 2 个国家目标入组 605 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 26
- 主要终点
- Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
详细描述
Allocation: Randomized Stratified
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
- •Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
- •HCV RNA viral load ≥10,000 IU/mL
- •No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
- •No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
- •Body mass index of 18 to 35 kg/m^2
- •Negative for HIV and hepatitis B virus
排除标准
- •Evidence of decompensated liver disease
- •Evidence of medical condition other than HCV contributing to chronic liver disease
研究组 & 干预措施
Daclatasvir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Daclatasvir (Drug)
Daclatasvir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Peginterferon alfa-2a (Drug)
Daclatasvir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Ribavirin (Drug)
Telaprevir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Telaprevir (Drug)
Telaprevir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Peginterferon alfa-2a (Drug)
Telaprevir + Peginterferon alfa-2a + Ribavirin
Experimental
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
时间窗: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.
次要结局
- Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4(Week 4)
- Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12(Week 4, Week 12)
- Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)(Week 12 (Follow-up period))
- Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)(Week 24 (Follow-up period))
研究者
研究点 (26)
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