Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

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

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion criteria:

• Chronic HCV genotype 1 infection

• No previous treatment for HCV infection

• African American ethnicity

• Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit

• A liver biopsy within 3 years prior to baseline

Exclusion criteria:

• HCV genotype different from genotype 1 or co-infection with other HCV genotype

• Co-infection with Hepatitis B or HIV

• Any other cause of relevant liver disease other than HCV

• Presence or history of hepatic decompensation

• Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply