A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
研究概览
简要总结
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
干预措施: Alisporivir (Drug)
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
干预措施: Peginterferon alfa-2a (Drug)
Alisporivir
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
时间窗: 12 weeks posttreatment
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
次要结局
- Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)(12 weeks posttreatment)
- Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)(24 weeks posttreatment)
- Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events(48 weeks)