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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 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.

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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.

Conditions Studied

Chronic Hepatitis C

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

FieldValue
Enrollment Target 50 participants
Start Date 2007-09
Est. Completion 2010-04
Phase Phase 2

Sponsor

Debiopharm International

30 total trials

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What the Registry Record Tells You About NCT00537407

The ClinicalTrials.gov registry entry for NCT00537407 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 211-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (76% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.