EUCTR2013-003751-38-FR进行中（未招募）1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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 performed;
- •2. HCV G2/3 patients who previously failed a course of interferon based therapy or were intolerant of interferon or are unable to take interferon based on the presence of a contraindication as defined by the label of pegIFN (Pegasys and/or PegIntron);
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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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