A Randomized, Open Label Trial of the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-INFα2a/RBV) and Boceprevir in Combination With Peg-INFα2a/RBV in African American Treatment-naïve Patients With Chronic Hepatitis C Genotype 1
Description
Brief 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 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion 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
- 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
Sites
-
California
- Novartis Investigational Site, Beverly Hills, California, 90211
Powered by
SC CTSI