A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed
- •Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
- •Males or females aged ≥18 years
- •Diagnosed Chronic hepatitis C virus infection
- •Exclusion criteria:
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •Hepatitis B surface antigen (HBsAg) positive
- •Human immunodeficiency virus (HIV) positive
- •Other protocol-defined inclusion/exclusion criteria apply.
排除标准
- 未提供
研究组 & 干预措施
Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
干预措施: Alisporivir (Drug)
Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
干预措施: Ribavirin (Drug)
Alisporivir 400 mg BID
ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
干预措施: Alisporivir (Drug)
Alisporivir 400 mg BID
ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
干预措施: Ribavirin (Drug)
结局指标
主要结局
Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
时间窗: Baseline, Week 12
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
时间窗: Baseline, Week 12
ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.
次要结局
- Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment(Up to 24 weeks posttreatment)
- Percentage of Participants With Extended Rapid Virologic Response(2 weeks)
- Percentage of Participants With Rapid Virologic Response (RVR)(4 weeks)
- Percentage of Participants With End of Treatment Response (ETR)(Up to 24 weeks)
- Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End(Up to 24 weeks)