Trial record 2 of 2 for:
debio-025
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:
Debiopharm S.A.
Information provided by (Responsible Party):
Debiopharm S.A.
ClinicalTrials.gov Identifier:
NCT00537407
First received: September 28, 2007
Last updated: August 7, 2012
Last verified: August 2012
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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 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, 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 S.A.
Investigators
| Study Director: | Raf Crabbé, MD | Debiopharm Group SA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Debiopharm S.A. |
| 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 S.A.:
|
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 May 19, 2013