EUCTR2012-004185-17-IT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
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 performed.
- •2. No previous treatment for Hepatitis C infection (i.e. HCV treatment-naïve)
- •3. Males or females aged =18 years
- •4. Body mass index (BMI) = 18 to = 33 kg/m2
- •5. 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 7
- •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.Confirmed fasting triglycerides level > 200 mg/dL (2.25 mmol/L)
- •5.Confirmed uncontrolled hypertension
- •6.HBsAg positive or HIV positive.
研究者
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