Completed

A Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C

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What is being tested

peginterferon alfa-2a [Pegasys]

+ Copegus

Drug
Who is being recruted

Blood-Borne Infections+16

+ Chronic Disease

+ Communicable Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Randomized, Open-label Study of Prophylactic Administration of PEGASYS Plus Ribavirin After Liver Transplantation on Hepatitis C Recurrence in Patients With Hepatitis C 
NCT00087633
Principal SponsorHoffmann-La Roche
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

115 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesEnterovirus InfectionsHepatitisHepatitis AHepatitis, ChronicHepatitis, Viral, HumanHepatitis CInfectionsLiver DiseasesPathologic ProcessesPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepatitis C, ChronicDisease Attributes

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers