An Exploratory Study to Evaluate the Kinetics of Viral Load Decline with Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy with Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment-Naïve Adults with Genotype 1a Chronic Hepatitis C Virus (HCV) Infection

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 60 人开始时间: 2015年6月23日最近更新: 2017年1月23日

适应症

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 GT1a infection.
•3. Chronic HCV infection.
•4. Subjects must be non-cirrhotic.
•5. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an IRB/EC approved informed consent.
•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 15

•1. Women who are pregnant or breastfeeding.
•2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
•3. Clinically significant abnormalities or co-morbidiites, other than HCV infection, that make the subject unsuitable for this study or treatment.
•4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegIFN, ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or NS5A inhibitors.
•5. History of solid organ transplant.
•6. Screening laboratory analysis that shows abnormal results.

发起方