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 Santa Fe New Mexico

Santa Fe, New Mexico 87505

1284

from 43215

Santa Fe, NM