A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C
peginterferon alfa-2a [Pegasys]
+ Copegus
Blood-Borne Infections+16
+ Chronic Disease
+ Communicable Diseases
Treatment Study
Summary
Study start date: October 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.115 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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 Criteria: * Multi-organ or re-transplant recipient * Evidence of current hepatitis B infection * Seropositive for human immunodeficiency (HIV) infection
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives