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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT00537407
First received: September 28, 2007
Last updated: August 7, 2012
Last verified: August 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

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

Enrollment: 50
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Debio-025
Peginterferon Alpha-2a/Ribavirin/Debio-025 400 mg
Experimental: B Drug: Debio-025
Peginterferon Alpha-2a/Debio 025 400 mg
Experimental: C Drug: Debio-025
Debio 025 400 mg
Experimental: D Drug: Debio-025
Peginterferon Alpha-2a/ribavirin/Debio 025 400 mg-800 mg
Experimental: E 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.

  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, 75203
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 International SA
Investigators
Study Director: Raf Crabbé, MD Debiopharm Group SA
  More Information

Additional Information:
No publications provided

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT00537407     History of Changes
Other Study ID Numbers: Debio 025-HCV-207
Study First Received: September 28, 2007
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Debiopharm International SA:
Hepatitis, Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014