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)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 130 人开始时间: 2015年8月21日最近更新: 2018年2月12日

试验速览

暂无简介。

•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 treatment-naïve (i.e., has never received a single dose of any approved or investigational regimen for treatment of HCV) or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without pegIFN therapy. Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed = 2 months prior to screening.
•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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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.

发起方