EUCTR2012-004905-29-BE进行中（未招募）1 期
A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 or Genotype 4 HCV Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- •- treatment-naïve with confirmed chronic Hepatitis C Virus (HCV)
- •- liver biopsy performed within 2 years prior to screening or noninvasive
- •confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
- •- liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or
- •portal fibrosis without or with few septa)
- •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 219
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •- Participants with advanced liver disease equivalent to Metavir score
- •F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with
- •any liver disease of non-HCV etiology, and/or with a non-genotype 1 or
- •non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study
研究者
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