A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection



Status:Active, not recruiting
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:November 2015
End Date:February 2017

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A Randomized, Double-Blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 2 Infection (ENDURANCE-2)

The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in
adults with genotype 2 chronic hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2)
infection.

- Chronic HCV infection.

- Subject must be HCV treatment-naïve or have failed previous HCV treatment.

- Subject must be non-cirrhotic.

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any excipient
of the study drugs.

- 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.

- 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.

- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).

- HCV genotype performed during screening indicating coinfection with more than 1 HCV
genotype.
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