A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

Status:	Completed
Conditions:	Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 70
Updated:	2/2/2017
Start Date:	April 2015
End Date:	January 2017

A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy

The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with
or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection
who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

Inclusion Criteria:

1. Previous treatment with DAA-containing regimen for chronic HCV infection resulting in
either on-treatment virologic failure or post-treatment relapse

2. Chronic HCV GT 1, 4, 5, or 6-infection

Exclusion Criteria:

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

4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus
antibody (HIV Ab)

5. Co-infection with more than one HCV genotype

We found this trial at

sites

Clinical Trial Facility in Manhasset New York

Manhasset, New York 11031

from

Manhasset, NY