A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2016-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• US military veteran currently receiving healthcare through the Veterans Health Administration

• Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection

• Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA > 1,000 IU/mL at the time of Screening or HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)

• Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir

• Any current or past clinical evidence of Child-Pugh B or C classification

• Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis