PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
1 other identifier
interventional
115
1 country
28
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2004
Longer than P75 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2004
CompletedFirst Posted
Study publicly available on registry
July 14, 2004
CompletedStudy Start
First participant enrolled
October 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
January 24, 2011
CompletedMarch 29, 2018
February 1, 2018
4 years
July 12, 2004
October 14, 2009
February 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)
Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2. Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe. Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis.
120 weeks postrandomization
Secondary Outcomes (1)
Summary of Virologic Response
After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up
Study Arms (2)
1
EXPERIMENTAL2
NO INTERVENTIONInterventions
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Phoenix, Arizona, 85054, United States
Unknown Facility
Los Angeles, California, 90095-1749, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Gainesville, Florida, 32610-0214, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33136-1051, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Baltimore, Maryland, 21205, United States
Unknown Facility
Burlington, Massachusetts, 01805, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68198-3285, United States
Unknown Facility
Newark, New Jersey, 07101-1709, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
San Antonio, Texas, 78284, United States
Unknown Facility
Seattle, Washington, 98195, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 21506241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2004
First Posted
July 14, 2004
Study Start
October 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 29, 2018
Results First Posted
January 24, 2011
Record last verified: 2018-02