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 |
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.
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
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