PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
NCT ID: NCT00087633
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
115 participants
INTERVENTIONAL
2004-10-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
peginterferon alfa-2a [Pegasys]
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
Copegus
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
2
No interventions assigned to this group
Interventions
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peginterferon alfa-2a [Pegasys]
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
Copegus
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence of current hepatitis B infection
* Seropositive for human immunodeficiency (HIV) infection
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Burlington, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Bzowej N, Nelson DR, Terrault NA, Everson GT, Teng LL, Prabhakar A, Charlton MR; PHOENIX Study Group. PHOENIX: A randomized controlled trial of peginterferon alfa-2a plus ribavirin as a prophylactic treatment after liver transplantation for hepatitis C virus. Liver Transpl. 2011 May;17(5):528-38. doi: 10.1002/lt.22271.
Other Identifiers
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ML18124
Identifier Type: -
Identifier Source: org_study_id
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