A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
Public ClinicalTrials.gov record NCT00537407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Debio 025 (alisporivir) 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 assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin can improve the outcome of treatment in this group of patients.
Study identification
- NCT ID
- NCT00537407
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2007
- Primary completion
- Mar 31, 2010
- Completion
- Mar 31, 2010
- Last update posted
- Feb 16, 2016
2007 – 2010
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Clinic Liver Disease Research Center | La Jolla | California | 92037 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | — |
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | — |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | — |
| Metropolitan Research | Fairfax | Virginia | 22031 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00537407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 16, 2016 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00537407 live on ClinicalTrials.gov.