At a glance
ClinicalIndex Comparison Record- ✓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
- ✕Multi-organ or re-transplant recipient
- ✕Evidence of current hepatitis B infection
- ✕Seropositive for human immunodeficiency (HIV) infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
In Brief
A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] and Copegus for Hepatitis C, Chronic. Completed, enrolled 115 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks
400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks