Study of DEB025/Alisporivir Plus Pegylated Interferon alfa2a and Ribavirin and Boceprevir Plus Pegylated Interferon alfa2a and Ribavirin in African American Chronic Hepatitis C Genotype 1 Patients That Have Never Received Treatment for Their Hepatitis C
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | May 2013 |
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-naϊve Patients With Chronic Hepatitis C Genotype 1
This study will assess the safety and efficacy of alisporivir plus pegylated interferon
alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in
African American chronic hepatitis C genotype 1 patients that have never received treatment
for their hepatitis C.
alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in
African American chronic hepatitis C genotype 1 patients that have never received treatment
for their hepatitis C.
Inclusion criteria:
- Chronic hepatitis C virus infection.
- Infection with HCV genotype 1
- No previous treatment for Hepatitis C virus 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
- ALT ≥ 10 times ULN, more than 1 episode of elevated bilirubin (>ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply
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