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

February 28, 2018 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With 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 treatment was 3-12 months, and the target sample size was 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Los Angeles, California, United States, 90095-1749
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94143
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32610-0214
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33136-1051
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Maryland
      • Baltimore, Maryland, United States, 21205
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3285
    • New Jersey
      • Newark, New Jersey, United States, 07101-1709
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19141
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Dallas, Texas, United States, 75246
      • San Antonio, Texas, United States, 78284
    • Washington
      • Seattle, Washington, United States, 98195
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients at least 18 years of age
  • Positive hepatitis C virus RNA at pre-transplantation
  • Primary, single-organ recipient (cadaveric donor)
  • Liver transplant between 10 and 16 weeks before treatment initiation

Exclusion Criteria:

  • Multi-organ or re-transplant recipient
  • Evidence of current hepatitis B infection
  • Seropositive for human immunodeficiency (HIV) infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: peginterferon alfa-2a [Pegasys]
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
Drug: Copegus
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
NO_INTERVENTION: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
Time Frame: 120 weeks postrandomization

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.
120 weeks postrandomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Virologic Response
Time Frame: After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up
Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.
After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

July 12, 2004

First Submitted That Met QC Criteria

July 13, 2004

First Posted (ESTIMATE)

July 14, 2004

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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