A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C Genotype 1 Treatment-naïve Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,081
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
研究概览
简要总结
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
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 Arm A
Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):
- Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks
- Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
干预措施: Alisporivir (Drug)
Treatment Arm A
Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):
- Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks
- Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
干预措施: Peginterferon alfa-2a (Drug)
Treatment Arm A
Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):
- Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks
- Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment
干预措施: Ribavirin (Drug)
Treatment Arm B
Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
干预措施: Alisporivir (Drug)
Treatment Arm B
Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
干预措施: Peginterferon alfa-2a (Drug)
Treatment Arm B
Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
干预措施: Ribavirin (Drug)
Treatment Arm C
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
干预措施: Alisporivir (Drug)
Treatment Arm C
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
干预措施: Peginterferon alfa-2a (Drug)
Treatment Arm C
Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
干预措施: Ribavirin (Drug)
Treatment Arm D
ALV Placebo with PEG and RBV for 48 weeks
干预措施: Peginterferon alfa-2a (Drug)
Treatment Arm D
ALV Placebo with PEG and RBV for 48 weeks
干预措施: Ribavirin (Drug)
Treatment Arm D
ALV Placebo with PEG and RBV for 48 weeks
干预措施: ALV Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
时间窗: 12 weeks after the end of treatment
SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
次要结局
- Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)(after 4 weeks of treatment)
- Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment(after 12 weeks of treatment)
- Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks(within 48 weeks)
- Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks(within 48 weeks)
- Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment(after 12 weeks of treatment)
- Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment(after 12 weeks of treatment)
- Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment(from 4 to 12 weeks of treatment)
- Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks(at treatment end within 48 weeks)
- Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks(within 48 weeks)
- Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)(24 weeks after the end of treatment)
- Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks(within 48 weeks)