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NCT00537407 · ClinicalTrials.gov registry record · Phase 2
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
A Phase 2 study of Chronic Hepatitis C, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 7
- Study locations
NCT00537407: Completed Phase 2 study of Chronic Hepatitis C, sponsored by Debiopharm International.
NCT00537407 is a Phase 2 study of Chronic Hepatitis C that has completed, run by Debiopharm International. The registered enrollment target is 50 participants, below the 211-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (76% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00537407, a Phase 2 study of Chronic Hepatitis C, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
Hepatitis C virus RNA was quantified in plasma samples using real time polymerase chain reaction.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Debio 025
- DRUG Peg-IFNα2a
Study Locations (7)
Florida
- University of Florida - Gainesville
- University of Miami Center for Liver Diseases - Miami
California
- Scripps Clinic Liver Disease Research Center - La Jolla
Maryland
- The Johns Hopkins University School of Medicine - Baltimore
Texas
- Methodist Transplant Physicians - Dallas
Virginia
- Metropolitan Research - Fairfax
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00537407 record still lists
NCT00537407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 211-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.
NCT00537407 lists 7 locations in 6 states (Florida, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT00537407 about?
NCT00537407 is a clinical study titled "A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment". 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. Treatm...
What is the current status of trial NCT00537407?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2007-09. Estimated completion is 2010-04.
What conditions does trial NCT00537407 study?
This clinical trial studies the following conditions: Chronic Hepatitis C.
What interventions are being tested in trial NCT00537407?
The interventions under investigation include: Ribavirin (DRUG), Debio 025 (DRUG), Peg-IFNα2a (DRUG).
Who is sponsoring clinical trial NCT00537407?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00537407 being conducted?
This trial has 7 study locations across California, Florida, Maryland, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00537407's enrollment target sits among peer trials
50 7th of 16 higher than 10 of 16 other Chronic Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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