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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

This study has been completed.
Information provided by (Responsible Party):
Debiopharm International SA Identifier:
First received: September 28, 2007
Last updated: August 4, 2014
Last verified: August 2014

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-interferon (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: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Debio 025 Arm A Drug: Debio 025
Peginterferon alpha-2a/ribavirin/Debio 025 400 mg
Experimental: Debio 025 Arm B Drug: Debio 025
Peginterferon alpha-2a/Debio 025 400 mg
Experimental: Debio 025 Arm C Drug: Debio 025
Debio 025 400 mg
Experimental: Debio 025 Arm D Drug: Debio 025
Peginterferon alpha-2a/ribavirin/Debio 025 400-800 mg
Experimental: Debio 025 Arm 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.


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

Inclusion Criteria:

  • Male and female patients between 18 and 60 years of age.
  • Hepatitis B negative and human immunodeficiency virus (HIV) negative.
  • Diagnosed with hepatitis C genotype I and not responsive to treatments such as peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks.
  • Adequate liver function (Child-Pugh-Turcotte score A) and other laboratory parameters within acceptable range.
  • Females may participate only if they cannot become pregnant, ie, 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 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00537407

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
Study Director: Raf Crabbé, MD Debiopharm International S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Debiopharm International SA Identifier: NCT00537407     History of Changes
Other Study ID Numbers: Debio 025-HCV-207
Study First Received: September 28, 2007
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Debiopharm International SA:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 23, 2014