EUCTR2014-003446-27-ES进行中（未招募）不适用
A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination with Sofosbuvir in Treatment-Naïve or -Experienced Subjects with Chronic Genotype 4 Hepatitis C Virus Infection
Janssen R&D Ireland0 个研究点开始时间: 2014年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •.Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (>) 10000 international unit per milliliter (IU/mL)
- •.Subjects who are treatment naive or treatment-experienced.
- •.Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
- •.Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging [MRI]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
- •.Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •.Evidence of clinical hepatic decompensation
- •.Any liver disease of non-HCV etiology
- •.Subjects with a past history of treatment with an approved or investigational DAA - Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
- •.Infection/co-infection with HCV non-genotype 4
研究者
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