EUCTR2016-004102-34-ES进行中（未招募）1 期
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1-6 Chronic Hepatitis C Virus (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
- 129
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. Hepatitis C Virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL.
- •2. Subject must have a weight consistent with a recommended weight range for their age at the time of screening. Subjects that fall out of the weight band for their age at the time of screening may be screened only into the safety and efficacy parts of the study upon TA MD approval.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Females who are pregnant or breastfeeding.
- •2. Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV DNA.
- •3. Participants with other known liver diseases.
- •4. Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child's class B or C cirrhosis.
研究者
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