Clinical trial NCT01429155: Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin 28 B
Official title: Post Transplant Course of Hepatitis C Patients After Living Donor Liver Transplant in Association With Interleukin 28 B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: End stage liver disease
Living donor liver transplantation
Hepatitis C
Interleukin 28B
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Sustained virological response after living donor liver transplant
timeFrame: 12-24 months
Secondary outcomes:
measure: Liver retransplantation
timeFrame: 1-24 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Humberto C Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charlton MR, Thompson A, Veldt BJ, Watt K, Tillmann H, Poterucha JJ, Heimbach JK, Goldstein D, McHutchison J. Interleukin-28B polymorphisms are associated with histological recurrence and treatment response following liver transplantation in patients with hepatitis C virus infection. Hepatology. 2011 Jan;53(1):317-24. doi: 10.1002/hep.24074.
citation: Eurich D, Boas-Knoop S, Ruehl M, Schulz M, Carrillo ED, Berg T, Neuhaus R, Neuhaus P, Neumann UP, Bahra M. Relationship between the interleukin-28b gene polymorphism and the histological severity of hepatitis C virus-induced graft inflammation and the response to antiviral therapy after liver transplantation. Liver Transpl. 2011 Mar;17(3):289-98. doi: 10.1002/lt.22235.