An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
研究概览
简要总结
The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.
详细描述
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Intervention Model:
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Parallel: for all patients entering the trial
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Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
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Peginterferon alfa-2a
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Ribavirin
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Daclatasvir
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Asunaprevir
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
- •Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
- •Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
- •HCV RNA viral load detectable
排除标准
- •Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
- •Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
- •Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
- •Evidence of medical condition associated with chronic liver disease other than HCV infection
- •Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
研究组 & 干预措施
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Ribavirin (Drug)
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Asunaprevir (Drug)
Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Pegylated interferon alfa-2a (Drug)
Daclatasvir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Pegylated interferon alfa-2a (Drug)
Daclatasvir + PegIFNα-2a + Ribavirin
Patients received daclatasvir, (two 30-mg tablets or one 60-mg tablet, by mouth once daily) + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
干预措施: Ribavirin (Drug)
Daclatasvir + Asunaprevir
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + Asunaprevir
Patients received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
干预措施: Asunaprevir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
时间窗: Week 12 (Follow-up period)
SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.
次要结局
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study(For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation)
- Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)(Week 12 (Follow-up period))
- Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4(Week 4)
- Percentage of Participants With Extended Rapid Virologic Response (eRVR)(Week 4 and 12)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Participants With End of the Treatment Response (EOTR)(End of the study (Week 24))
- Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)(Week 24 (Follow-up))