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NCT00087633 · ClinicalTrials.gov registry record · Phase 4

PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.

A Phase 4 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
115
Enrollment target
20
Study locations

NCT00087633: Completed Phase 4 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

NCT00087633 is a Phase 4 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 115 participants, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00087633, a Phase 4 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
115 participants
Enrollment target
20
Study locations

Study Summary

This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.

Primary Outcome

Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG Copegus
  • DRUG peginterferon alfa-2a [Pegasys]

Study Locations (20)

California

  • - Los Angeles
  • - San Francisco
  • - San Francisco

Florida

  • - Gainesville
  • - Jacksonville
  • - Miami

Minnesota

  • - Minneapolis
  • - Rochester

New York

  • - New York
  • - New York

Alabama

  • - Birmingham

Arizona

  • - Phoenix

Colorado

  • - Aurora

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2004-10
Est. Completion 2008-10
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT00087633 record still lists

NCT00087633 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 372-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (69% lower).

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Copegus is the first listed.

NCT00087633 names 20 study sites across 14 states, led by California, Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT00087633 about?

NCT00087633 is a clinical study titled "PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.". This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study tr...

What is the current status of trial NCT00087633?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 115 participants. The study started on 2004-10. Estimated completion is 2008-10.

What conditions does trial NCT00087633 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT00087633?

The interventions under investigation include: Copegus (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).

Who is sponsoring clinical trial NCT00087633?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00087633 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatitis C, Chronic

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 NCT00087633's enrollment target sits among peer trials

115 14th of 26 higher than 13 of 26 other Hepatitis C, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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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Related registry views

Source: ClinicalTrials.gov NCT00087633, the US trial registry maintained by the National Library of Medicine. NCT00087633 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.