Safety and Effectiveness Using Pegasys and Copegus in Recipients of Liver Transplantation With Hepatitis C
A Prospective, Randomized, Multi-center, Open-label, Comparative Safety and Efficacy Study of Prophylactically Administered Pegylated Interferon Alfa-2a(Pegasys) Plus Ribavirin vs. No Prophylaxis Following Liver Transplantation for Hepatitis C.
1 other identifier
interventional
12
1 country
1
Brief Summary
The study is being done to study the impact of prophylactic administration of antiviral therapy as compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection in liver transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedNovember 11, 2011
November 1, 2011
2.9 years
January 10, 2006
November 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients in each group who experienced histologically confirmed recurrence of HCV at 120 weeks post randomization.
96 weeks
Secondary Outcomes (5)
The proportion of patients who have non-detectable serum HCV-RNA measured by Quanta Sure plus HCV test and HCV RNA negative by quantitative PCR at week 12, 24, and 48 following initiation of treatment or on observation.
96 weeks
Virological response rate to antiviral therapy at week 12, week 24, and week 48 of therapy among patients who received antiviral therapy in either study arm.
96 weeks
Sustained virological response rate: the virological response at the conclusion of the 24 weeks treatment free follow-up period or 72 weeks on observation (for patients who received no treatment).
96 weeks
The virological response at the conclusion of the 24 weeks treatment-free follow-up period among patients who received antiviral therapy in either arm of the study.
96 weeks
Patient death or graft failure (as indicated by retransplantation).
96 weeks
Study Arms (2)
The Preventative (Prophylaxis) Group:
OTHERThis group of patients will receive study drugs for the treatment of recurring (or returning) hepatitis C before they actually develop clinical symptoms of hepatitis C.
The Observational Group:
OTHERThis group of patients will receive the study drugs for the treatment of recurring hepatitis C only if they develop the clinical symptoms of hepatitis C infection.
Interventions
135-180 micrograms administered sc once weekly
400-1200 mg/day for 48 weeks
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Roche Pharma AGcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R. Charlton, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 12, 2006
Study Start
July 1, 2004
Primary Completion
June 1, 2007
Study Completion
April 1, 2009
Last Updated
November 11, 2011
Record last verified: 2011-11