A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)

• Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening

• Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants

• Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.

• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

• Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.

Exclusion Criteria:

• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody

• Evidence of current or past Child-Pugh B or C classification

• Confirmed presence of hepatocellular carcinoma

• Abnormal laboratory tests

• Participant who self-reported on average drinking more than 2 drinks per day for current drinkers

• Previous treatment with a direct acting antiviral agent (DAA) containing regimen

• History of solid organ transplant.