EUCTR2011-001180-53-HU进行中（未招募）不适用
A Phase III, randomized, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFNa-2a and ribavirin, in chronic hepatitis C genotype-1 infectedsubjects who were null or partial responders to prior PegIFNa and ribavirin therapy. - ATTAI
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
- 744
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
- •- Genotype 1 hepatitis C infection (confirmed at screening)
- •- A liver biopsy within 3 years before screening (or between the screening and baseline) is required, showing chronic hepatitis C infection. In case of contradicitions, alternative methods must be used to determine or confirm the stage of liver disease.
- •- patient must have had at least 1 documented previous course of treament with PegINFa-2a or PegINFa-2b in combination with RBV (at least 12 weeks for null responder and 20 for partial responder)
- •- Plasma HCV RNA of >10,000 IU/mL at screening
- •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 728
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- Infection with HIV or non genotype 1 hepatitis C
- •- liver disease not related to hepatitic C infection
- •- hepatic decompensation
- •- significant laboratory abnormalities or other active diseases
- •- previous CHC treatment other than PegIFN and RBV
- •- pregnant or planning to become pregnant
研究者
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