A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and patients.

The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated. Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Male and female patients between 18 and 60 years of age.

• Hepatitis B negative and human immunodeficiency virus (HIV) negative.

• Diagnosed with hepatitis C genotype I and not responsive to treatments such as peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks.

• Adequate liver function (Child-Pugh-Turcotte score A) and other laboratory parameters within acceptable range.

• Females may participate only if they cannot become pregnant, i.e., are surgically sterile, post-menopausal, or using 2 reliable contraceptive methods.

• Male patients must be surgically sterile or utilizing a barrier contraceptive method.

• For female patients of child bearing potential, negative pregnancy test within 1 week of first investigational product administration.

Exclusion Criteria:

• Treatment with any investigational drug within 6 months prior to the start of the study.

• Ongoing or recent use of antiviral medication within 1 month before the start of the study.

• A known bad reaction or intolerance to Debio 025, peginterferon alpha-2a, and/or ribavirin.

• Presence or history of any severe related disease.