A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
研究概览
简要总结
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment B: ALV 800 mg QD
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
干预措施: Alisporivir (Drug)
Treatment A: ALV 600 mg QD
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
干预措施: Ribavirin (Drug)
Treatment A: ALV 600 mg QD
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
干预措施: Alisporivir (Drug)
Treatment A: ALV 600 mg QD
Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks
干预措施: Peginterferon alfa-2a (Drug)
Treatment B: ALV 800 mg QD
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
干预措施: Peginterferon alfa-2a (Drug)
Treatment B: ALV 800 mg QD
Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks
干预措施: Ribavirin (Drug)
Treatment C1: ALV Placebo - 600 mg QD
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
干预措施: Alisporivir (Drug)
Treatment C1: ALV Placebo - 600 mg QD
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
干预措施: Peginterferon alfa-2a (Drug)
Treatment C1: ALV Placebo - 600 mg QD
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
干预措施: Ribavirin (Drug)
Treatment C1: ALV Placebo - 600 mg QD
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.
干预措施: Placebo (Drug)
Treatment C2: ALV Placebo - 400 mg BID
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
干预措施: Alisporivir (Drug)
Treatment C2: ALV Placebo - 400 mg BID
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
干预措施: Peginterferon alfa-2a (Drug)
Treatment C2: ALV Placebo - 400 mg BID
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
干预措施: Ribavirin (Drug)
Treatment C2: ALV Placebo - 400 mg BID
ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
干预措施: Placebo (Drug)
Treatment D: ALV 400 mg BID
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
干预措施: Alisporivir (Drug)
Treatment D: ALV 400 mg BID
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
干预措施: Peginterferon alfa-2a (Drug)
Treatment D: ALV 400 mg BID
Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
时间窗: after 12 weeks of treatment
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
次要结局
- Percentage of Participants With Viral Relapse(within 24 weeks after treatment)
- Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)(after 12 weeks of treatment)
- Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD(24 weeks after treatment)
- Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD(within 48 weeks)
- Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End(Up to 48 weeks)
- Percentage of Participants With On-treatment Viral Breakthrough(within 48 weeks)
- Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD(12 weeks after treatment)
- Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD(after 4 weeks of treatment)
- Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD(after 12 weeks of treatment)