A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)



Status:Completed
Conditions:Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:10/14/2017
Start Date:November 2013
End Date:June 2015

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A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of
ABT-493 and ABT-530 in adults with genotype 1 HCV.


Inclusion Criteria:

- Chronic HCV infection prior to study enrollment.

- Screening laboratory result indicating HCV genotype 1-infection.

- Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

- Per local standard, subject is considered to be non-cirrhotic or to have compensated
cirrhosis.

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any drug.

- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
Immunodeficiency Virus antibody (HIV Ab).

- Prior therapy for the treatment of HCV.

- Any current or past clinical evidence of Child Pugh B or C classification of clinical
history of liver decompensation including ascites (noted on physical exam), variceal
bleeding or hepatic encephalopathy.

- Any cause of liver disease other than chronic HCV infection.
We found this trial at
13
sites
343
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Phoenix, AZ
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Atlanta, GA
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Aurora, CO
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Baltimore, MD
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1793
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Indianapolis, IN
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1341
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Kansas City, MO
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565
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Murray, UT
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2435
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New York, NY
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2182
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Orlando, FL
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36
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Rialto, CA
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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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964
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Seattle, WA
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