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

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ClinicalTrials.gov Identifier: NCT01429155
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Humberto C. Gonzalez, Henry Ford Health System

September 2, 2011
September 5, 2011
September 17, 2014
August 2011
January 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01429155 on ClinicalTrials.gov Archive Site
Liver retransplantation [ Time Frame: 1-24 months ]
Determine the need of liver retransplantion based on the IL 28B genotype
Same as current
Not Provided
Not Provided
 
Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin 28 B
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood
Non-Probability Sample

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.

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)
  • Liver transplant recipeints
    Patients suffering from chronic hepatitis C that required a living donor liver transplant.
    Intervention: Genetic: Interleukin 28B genotype
  • Liver Donors
    Patients who donated part of their liver to a patient suffering from chronic hepatitis C
    Intervention: Genetic: Interleukin 28B genotype

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
40
March 2013
January 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01429155
6975
Yes
Not Provided
Not Provided
Humberto C. Gonzalez, Henry Ford Health System
Henry Ford Health System
Not Provided
Principal Investigator: Humberto C Gonzalez, MD Henry Ford Hospital
Henry Ford Health System
September 2014