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

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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
21
sites
964
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Seattle, WA
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8190
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Adelaide,
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Arlington, TX
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Bakersfield, CA
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Baltimore, MD
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2194
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Chapel Hill, NC
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1729
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Chicago, IL
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DeLand, FL
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1899
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Dothan, AL
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1600
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Germantown, TN
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1600
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Germantown, TN
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2175
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Lynchburg, VA
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2448
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Manhasset, NY
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1946
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Novi, MI
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2433
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Poughkeepsie, NY
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1188
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San Antonio, TX
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105
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San Diego, CA
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355
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San Francisco, CA
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690
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Santa Fe, NM
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1401
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Shreveport, LA
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Statesville, North Carolina 28677
2093
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Statesville, NC
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