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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug); Copegus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)

Secondary outcome: Summary of Virologic Response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Birmingham, Alabama 35294, United States

Phoenix, Arizona 85054, United States

Los Angeles, California 90095-1749, United States

San Francisco, California 94115, United States

San Francisco, California 94143, United States

Aurora, Colorado 80045, United States

Gainesville, Florida 32610-0214, United States

Jacksonville, Florida 32216, United States

Miami, Florida 33136-1051, United States

Chicago, Illinois 60611, United States

Indianapolis, Indiana 46202, United States

Baltimore, Maryland 21205, United States

Burlington, Massachusetts 01805, United States

Minneapolis, Minnesota 55455, United States

Rochester, Minnesota 55905, United States

St Louis, Missouri 63110, United States

Omaha, Nebraska 68198-3285, United States

Newark, New Jersey 07101-1709, United States

New York, New York 10016, United States

New York, New York 10029, United States

Cincinnati, Ohio 45267, United States

Philadelphia, Pennsylvania 19141, United States

Philadelphia, Pennsylvania 19104, United States

Nashville, Tennessee 37232, United States

Dallas, Texas 75246, United States

San Antonio, Texas 78284, United States

Seattle, Washington 98195, United States

Madison, Wisconsin 53792, United States

Additional Information

Clinical Study Report Synopsis

Starting date: October 2004
Last updated: December 22, 2010

Page last updated: August 23, 2015

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