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

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00087633

Run by

Hoffmann-La Roche

People needed

115

Starts

2004-10-01

Expected to finish

2008-10-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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