Status:
COMPLETED
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- Multi-organ or re-transplant recipient
- Evidence of current hepatitis B infection
- Seropositive for human immunodeficiency (HIV) infection
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00087633
Start Date
October 1 2004
End Date
October 1 2008
Last Update
March 29 2018
Active Locations (28)
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1
Birmingham, Alabama, United States, 35294
2
Phoenix, Arizona, United States, 85054
3
Los Angeles, California, United States, 90095-1749
4
San Francisco, California, United States, 94115