Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

August 31, 2010 updated by: Novartis

Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)

The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.

The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)

Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
12-month cumulative incidence of post-surgical graft loss and death

Secondary Outcome Measures

Outcome Measure
hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 1, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCHI621AIT06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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