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Sponsored by: |
Debiopharm S.A. |
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Information provided by: | Debiopharm S.A. |
ClinicalTrials.gov Identifier: | NCT00537407 |
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 |
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Chronic Hepatitis C |
Drug: Debio-025 |
Phase II |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Debio-025
Peginterferon Alpha-2a/Ribavirin/Debio-025 400 mg
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B: Experimental |
Drug: Debio-025
Peginterferon Alpha-2a/Debio 025 400 mg
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C: Experimental |
Drug: Debio-025
Debio 025 400 mg
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D: Experimental |
Drug: Debio-025
Peginterferon Alpha-2a/ribavirin/Debio 025 400 mg-800 mg
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E: Experimental |
Drug: Debio-025
Peginterferon Alpha-2a/ribavirin/Debio 025 800 mg
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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:
Exclusion Criteria:
United States, California | |
Scripps Clinic Liver Disease Research Center | |
la Jolla, California, United States, 92037 | |
Research & Education Inc. | |
San Diego, California, United States, 92115 | |
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 |
Study Director: | Raf Crabbé, MD | Debiopharm Group SA |
Responsible Party: | Debiopharm S.A. ( Raf Crabbé, M.D. ) |
Study ID Numbers: | Debio 025-HCV-207 |
Study First Received: | September 28, 2007 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00537407 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatitis, Hepatitis C |
Antimetabolites Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Flaviviridae Infections Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |