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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00537407

Run by

Debiopharm International SA

People needed

50

Starts

2007-09-01

Expected to finish

2010-04-01

Last updated by the study team

2016-02-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps Clinic Liver Disease Research Center — La Jolla, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami Center for Liver Diseases — Miami, Florida, United States
• The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Methodist Transplant Physicians — Dallas, Texas, United States
• Metropolitan Research — Fairfax, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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