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
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antiviral Agents; Ribavirin

Criteria

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.