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

NCT ID: NCT01429155

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Liver transplant recipeints

Patients suffering from chronic hepatitis C that required a living donor liver transplant.

Interleukin 28B genotype

Intervention Type 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)

Liver Donors

Patients who donated part of their liver to a patient suffering from chronic hepatitis C

Interleukin 28B genotype

Intervention Type 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)

Interventions

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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)

Intervention Type GENETIC

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Humberto C. Gonzalez

Gastroenterology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Humberto C Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21254179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21384511 (View on PubMed)

Other Identifiers

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6975

Identifier Type: -

Identifier Source: org_study_id

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