EUCTR2011-002748-28-DE进行中（未招募）不适用
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
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
- 170
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, age = 18 years
- •3. Confirmation of chronic HCV infection
- •4. Subjects must have a liver biopsy performed = 3 years prior to screening indicating the
- •absence of cirrhosis
- •5. Monoinfection with HCV GT 1a or 1b
- •6. HCV RNA = 104 IU/mL at screening
- •7. Prior treatment and adherence with one course of pegylated interferon alfa and RBV
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
- •2. Prior treatment of HCV with any direct-acting antiviral or other interferons (whether approved or experimental)
- •3. Pregnant or nursing female or male with pregnant female partner
- •4. History of significant cardiac disease
- •5. Presence of autoimmune disorders
- •6. Known cirrhosis
- •7. Chronic liver disease of a non-HCV etiology
- •8. Poorly-controlled diabetes mellitus
- •9. Untreated or significant psychiatric illnesses
- •10. Severe chronic obstructive pulmonary disease
研究者
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