Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin 28 B

September 16, 2014 updated by: Humberto C. Gonzalez, Henry Ford Health System

Post Transplant Course of Hepatitis C Patients After Living Donor Liver Transplant in Association With Interleukin 28 B

Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Recently particular polymorphisms of IL-28B gene were reported to correlate with histological recurrence and antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar results have not been described yet in living donor liver transplant patients.

There is data suggesting slightly inferior outcomes in living donor liver transplants when done for hepatitis C. The investigators postulate that such inferior outcomes may be related to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive similarly unfavorable polymorphism livers from their relatives).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic hepatitis C patients that required a living donor liver transplant will be identified from the liver tranplant registry.

Living liver donors will be indentified from the liver tranplant registry.

Description

Inclusion Criteria:

  • Patients who received a living donor liver transplant for chronic hepatitis C who are 18 year or older
  • Patients who donated part of their liver to patients suffering from chronic hepatitis C. Donors must be 18 years or older

Exclusion Criteria:

  • Patients who are not willing to sign the consent
  • Inability to obtain liver specimen (recipients)
  • Inability to obtain blood sample (donors)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver transplant recipeints
Patients suffering from chronic hepatitis C that required a living donor liver transplant.
Genetic: Interleukin 28B genotype
Interleukin 28B genotype will be obtained from a tissue block of the liver explant (liver transplanted patients) Interleukin 28B genotype will be obtained from a blood sample drawn (liver donors)
Liver Donors
Patients who donated part of their liver to a patient suffering from chronic hepatitis C
Genetic: Interleukin 28B genotype
Interleukin 28B genotype will be obtained from a tissue block of the liver explant (liver transplanted patients) Interleukin 28B genotype will be obtained from a blood sample drawn (liver donors)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response after living donor liver transplant
Time Frame: 12-24 months
Determine if sustained virological response is achieved after liver transplantation for hepatitis C with antiviral therapy (rivabirin and pegelated interferon) based on patient IL28B genotype
12-24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver retransplantation
Time Frame: 1-24 months
Determine the need of liver retransplantion based on the IL 28B genotype
1-24 months

Collaborators and Investigators

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

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Humberto C Gonzalez, MD, Henry Ford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6975

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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