EUCTR2011-000944-43-DE进行中（未招募）不适用
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly with GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects with Chronic Genotype 1 HCV Infection
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
- 120
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. Willing and able to provide written informed consent.
- •2. Male or female, aged from 18 to 70 years old, inclusive.
- •3. Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
- •4. Subjects must have a liver biopsy performed = 2 years prior to Screening indicating the
- •absence of cirrhosis.
- •5. Monoinfection with HCV GT 1a or 1b.
- •6. HCV treatment naïve
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Pregnant female or male with pregnant female partner.
- •2. Poorly-controlled diabetes mellitus
- •3. History of clinically significant hemoglobinopathy
- •4. History of clinically significant retinal disease
- •5. History of invasive malignancy diagnosed or treated within 5 years
- •6. Untreated or significant psychiatric illnesses
- •7. Co-infection with HBV or HIV
- •12. Known cirrhosis
- •13. Chronic liver disease of a non-HCV etiology
- •14. History of solid organ transplantation
- •15. Suspicion of hepatocellular carcinoma
研究者
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