EUCTR2010-020034-26-DE进行中（未招募）不适用
A multicenter, randomized, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFN alpha-2a plus ribavirin) in treatment-naïve hepatitis C genotype 2 and 3 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
- 400
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
- •Key inclusion criteria are:
- •Written informed consent prior to any assessment;
- •Males or females aged =18 and = 70 years;
- •BMI between = 18 and = 36 kg/m2;
- •Chronic hepatitis C virus infection;
- •Plasma HCV RNA = 10000 IU/ml; no upper limit;
- •Infection with HCV genotype 2 or 3;
- •HCV treatment naïve;
- •Female patients of child bearing potential must have a negative pregnancy test at screening and immediately prior to first administration of study drug.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria are:
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer;
- •Any contraindications to peg-IFNa2a and/or RBV treatment;
- •Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years;
- •HBsAg positive or HIV positive;
- •Elevated (= ULN) total bilirubin level at screening.
- •Gilbert´s disease.
研究者
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