Outcomes in Hepatitis C After Living Donor Liver Transplantation 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases End Stage Liver Disease Flaviviridae Infections Hepatic Insufficiency Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Liver Failure RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interleukin 28B genotype

Genetic

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)

Primary outcomes

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

Secondary outcomes

Liver retransplantation

Time frame: 1-24 months

Determine the need of liver retransplantion based on the IL 28B genotype

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 5, 2011
Registry last updated: Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed