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

NCT00537407 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-02-17

Study results available
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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.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Debio 025

Debio 025 supplied as a 100 mg/mL oral solution

DRUG

Peg-IFNα2a

Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes

DRUG

Ribavirin

Ribavirin supplied as 200 mg tablets

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Raf Crabbé, MD · Debiopharm International S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537407 on ClinicalTrials.gov