EUCTR2012-004185-17-PL进行中（未招募）不适用
A multicenter, open-label, randomized, 3-arm, phase II profiling trial of pharmacokinetics, pharmacodynamics and safety of DEB025/Alisporivir in combination with ribavirin therapy in chronic hepatitis C genotype 2 and 3 treatment naïve patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is
- •2. No previous treatment for Hepatitis C infection (i.e. HCV treatmentnaïve)
- •3. Chronic hepatitis C virus infection diagnosed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Use of other investigational drugs at the time of enrollment, or
- •within 30 days or 5 half-lives of that medication before enrollment.
- •2. History of hypersensitivity to any of the study drugs or to drugs of
- •similar chemical classes
- •3. History of pancreatitis or history strongly suggestive of previous
- •pancreatitis
- •4. HBsAg positive or HIV positive.
研究者
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