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A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

NCT00854802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2016-02-17

No results posted yet for this study

Summary

The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Debio 025

Debio 025 supplied in soft gel capsules

DRUG

Peg-IFNα2a

Peg-IFNα2a supplied in pre-filled syringes

DRUG

Ribavirin

Ribavirin supplied in tablets

DRUG

Debio 025 placebo

Debio 025 placebo supplied in soft gel capsules

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Rafael Crabbé, MD · Debiopharm International SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Romania
  • Spain

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 NCT00854802 on ClinicalTrials.gov