A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 22
- 主要终点
- Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
研究概览
简要总结
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
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 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
ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
干预措施: Alisporivir (Drug)
ALV 600 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
干预措施: Alisporivir (Drug)
ALV 600 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
干预措施: Ribavirin (Drug)
ALV 800 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
干预措施: Alisporivir (Drug)
ALV 800 mg+RBV
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
干预措施: Ribavirin (Drug)
ALV 600 mg+PEG
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
干预措施: Alisporivir (Drug)
ALV 600 mg+PEG
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
干预措施: Peginterferon alfa-2a (Drug)
PEG+RBV
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
干预措施: Peginterferon alfa-2a (Drug)
PEG+RBV
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
时间窗: after 4 weeks of treatment
RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
次要结局
- Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)(after 4 weeks of treatment)
- Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)(after 4 weeks of treatment)
- Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)(after 4 weeks of treatment)
- Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)(after 12 weeks of treatment)
- Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)(at end of treatment, within 24 weeks)
- Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)(12 weeks after the end of treatment)
- Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)(after 12 weeks of treatment)
- Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)(after 12 weeks of treatment)
- Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)(24 weeks after the end of treatment)
- Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)(24 weeks after the end of treatment)
- Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)(at end of treatment, within 24 weeks)
- Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)(at end of treatment, within 24 weeks)
- Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)(12 weeks after the end of treatment)
- Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)(12 weeks after the end of treatment)
- Percentage of Participants With On-treatment Viral Breakthrough(within 24 weeks of treatment)
- Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)(24 weeks after the end of treatment)
- Percentage of Participants With Viral Relapse(within 24 weeks after the end of treatment)