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

Debiopharm

Status and phase: Terminated; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Peginterferon alfa-2a; Drug: Boceprevir; Drug: Alisporivir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01446250

CDEB025A2307

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Alisporivir

Experimental group

Description:

At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.

Treatment:

Drug: Alisporivir

Drug: Ribavirin

Drug: Peginterferon alfa-2a

Boceprevir

Active Comparator group

Description:

Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).

Treatment:

Drug: Boceprevir

Drug: Ribavirin

Drug: Peginterferon alfa-2a