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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429155
• Other study ID #: 6975
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: September 16, 2014
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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)

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response after living donor liver transplant	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	No
Secondary	Liver retransplantation	Determine the need of liver retransplantion based on the IL 28B genotype	1-24 months	No