EUCTR2014-001953-18-BE进行中（未招募）不适用
An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ ABT-450/ Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •-Males or females at least 18 years of age at time of screening
- •-Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than
- •or equal to 1,000 IU/mL at screening
- •-HCV genotype 1b infection confirmed at screening
- •-Compensated cirrhosis defined as Child Pugh A (score 5 or 6) at screening
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •-Women who are pregnant or breastfeeding
- •-Significant sensitivity to any drug
- •-Use of contraindicated medications within 2 weeks of dosing
- •-Abnormal laboratory tests
- •-Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
研究者
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