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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 28, 2007

Last Updated Date

January 16, 2009

Start Date ^†

November 2007

Current Primary Outcome Measures ^†

Log10 HCV RNA change from baseline [ Time Frame: after 29 days of therapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00537407 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Viral response rates, Safety parameters,Drug pharmacokinetics. [ Time Frame: weeks 4, 12, 24 after end of treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

An Open-Label, Randomized, 5-Arm, Parallel-Group Study of the Effects on Viral Kinetics, Safety and Pharmacokinetics of Different Dosing Regimens of Debio 025 in Combination With Peginterferon Alpha-2a and Ribavirin in Chronic HCV Genotype 1 Patients Who Are Non Responders to Standard Peginterferon Alpha and Ribavirin Treatment

Brief Summary

Debio 025 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 will assess whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.

Detailed Description

This is a multicentre, open-label, randomized, 5 arm parallel-group, multiple dose study in 50 chronic HCV genotype 1 non-responders to standard treatment with peg-IFN alpha (2a or 2b) and ribavirin for at least 12 weeks. The entire study will last a maximum of 96 weeks and will consist of a 48- or 72-week treatment period (according to response) divided into 2 distinct treatment parts. A follow up visit to assess SVR will take place 24 weeks after treatment cessation, i.e. at study Week 72 or 96.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Chronic Hepatitis C

Intervention ^†

Drug: Debio-025

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

August 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Male and female patients between 18 and 60 years of age
Hepatitis B negative and HIV negative
Diagnosed with Hepatitis C genotype I, not responsive to treatments such as peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks
Adequate liver function (CPT 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 one 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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537407

Responsible Party

Raf Crabbé, M.D., Debiopharm S.A.

Secondary IDs ^††

Study Sponsor ^†

Debiopharm S.A.

Collaborators ^††

Investigators ^†

Study Director:

Raf Crabbé, MD

Debiopharm Group SA

Information Provided By

Debiopharm S.A.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.