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



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2004
End Date:October 2008

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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.


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
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25
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