A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:August 2014
End Date:February 2016

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An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

The purpose of this study to evaluate the efficacy, safety, and pharmacokinetics of
co-administration of ABT-493 and ABT-530 with and without ribavirin in subjects with HCV
Genotype 1, 4, 5, and 6 infection.


Inclusion Criteria:

1. Male or female between 18 and 70 years of age, inclusive, at time of screening.

2. Screening laboratory result indicating HCV GT1, GT4, GT 5, or GT6 infection.

3. Chronic HCV infection.

4. Subject must be either HCV treatment-naïve or combination of pegylated-interferon
ribavirin experienced.

5. Subjects must be documented as non-cirrhotic or cirrhotic.

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 in the opinion of the
investigator.

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

5. HCV genotype performed during screening indicating co-infection with more than one
HCV genotype.
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23
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2270
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Binghamton, NY
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Adelaide,
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Indianapolis, IN
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Nashville, TN
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2415
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Newport News, VA
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147
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Portland, OR
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San Antonio, TX
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681
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1821
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Shreveport, LA
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1720
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St. Louis, MO
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