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

Sponsored by:	Debiopharm S.A.
Information provided by:	Debiopharm S.A.
ClinicalTrials.gov Identifier:	NCT00537407

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: Debio-025	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Debiopharm S.A.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Viral response rates(Rapid Viral Resp.[week 4],Early Viral Resp.[week 12],End Treatment Resp.,Sustained Viral Resp.[24 weeks after end treatment],Safety parameters(AEs,safety lab.data,vital signs,ECGs),Drug pharmacokinetics. [ Time Frame: weeks 4, 12, 24 after end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Debio-025 Peginterferon Alpha-2a/Ribavirin/Debio-025 400 mg
B: Experimental	Drug: Debio-025 Peginterferon Alpha-2a/Debio 025 400 mg
C: Experimental	Drug: Debio-025 Debio 025 400 mg
D: Experimental	Drug: Debio-025 Peginterferon Alpha-2a/ribavirin/Debio 025 400 mg-800 mg
E: Experimental	Drug: Debio-025 Peginterferon Alpha-2a/ribavirin/Debio 025 800 mg

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.

During treatment part 1 (study Weeks 1 to 4), patients will be randomized into one of 5 arms and will receive 4 weeks of investigational treatments with Debio 025. During treatment part 2 (study Weeks 5 to 48 or 72) patients will receive standard doses of peg IFN alpha 2a/ribavirin dual therapy.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537407

Locations

United States, California
Scripps Clinic Liver Disease Research Center
la Jolla, California, United States, 92037
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
University of Miami Center for Liver Diseases
Miami, Florida, United States, 33136
United States, Maryland
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Texas
Methodist Transplant Physicians
Dallas, Texas, United States, 75208
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Debiopharm S.A.

Investigators

Study Director:

Raf Crabbé, MD

Debiopharm Group SA

More Information

sponsor's site This link exits the ClinicalTrials.gov site

CRO's site This link exits the ClinicalTrials.gov site

Responsible Party:	Debiopharm S.A. ( Raf Crabbé, M.D. )
Study ID Numbers:	Debio 025-HCV-207
Study First Received:	September 28, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00537407
Health Authority:	United States: Food and Drug Administration

Keywords provided by Debiopharm S.A.:

Hepatitis, Hepatitis C

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Ribavirin
Peginterferon alfa-2a
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action

Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009