Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

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

Details

• Lead Sponsor: AbbVie
• Treatments: Ribavirin; Ritonavir

Criteria

Inclusion Criteria:

• Chronic hepatitis C, genotype 4-infection (hepatitis C virus [HCV] ribonucleic acid [RNA] level greater than 1,000 IU/mL at Screening)

• Subjects must meet one of the following:

• Treatment-naive: Subject has never received antiviral treatment for HCV infection OR

• Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegylated-interferon [pegIFN]/RBV);

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

• In substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or Fibroscan

• In substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening and confirmed absence of hepatocellular carcinoma

Exclusion Criteria:

• Females who are pregnant or breastfeeding

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

• HCV genotype performed during screening indicating unable to genotype or co-infection with any other HCV genotype

• abnormal laboratory tests

• self-reports current drinking more than 2 drinks per day

• current enrollment in another investigational study

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

• In substudy 1, evidence of liver cirrhosis

• In substudy 2, evidence of current or past Child-Pugh B or C classification and confirmed presence of hepatocellular carcinoma