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 |
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.
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.
We found this trial at
14
sites
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