EUCTR2014-002925-36-GB进行中（未招募）1 期
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 174
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 between 18 and 70 years of age, inclusive, at time of screening
- •2.Screening laboratory result indicating HCV GT1, GT4, GT5, or GT6 infection
- •3.Chronic HCV infection
- •4.Subject must be either HCV treatment-naïve or PR experienced (PR-null responder in Part 1).
- •5.Per local standards, subjects are considered to be non-cirrhotic or to have compensated cirrhosis (Part 2 GT1 only).
- •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 310
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.History of severe, life-threatening or other significant sensitivity to any drug.
- •2.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
- •3.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
- •4.Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- •5.HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
研究者
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