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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
NCT00537407 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00537407
The ClinicalTrials.gov registry entry for NCT00537407 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00537407 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00537407?
The interventions under investigation include: Ribavirin (DRUG), Debio 025 (DRUG), Peg-IFNα2a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00537407?
This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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