EUCTR2015-002349-80-IT进行中（未招募）1 期
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4) - ENDURANCE - 4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
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
入选标准
- •1. Male or female, at least 18 years of age at time of Screening.
- •2. Screening laboratory result indicating HCV GT4, 5, or 6 infection.
- •3. Chronic HCV infection.
- •4. Subject must be HCV DAA treatment-naïve.
- •5. Subjects are considered to be non-cirrhotic as per protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
- •2. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- •3. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- •4. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- •5. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
研究者
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