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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01429155
Enrollment
36
Registered
2011-09-05
Start date
2011-08-31
Completion date
2013-03-31
Last updated
2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

End stage liver disease, Living donor liver transplantation, Hepatitis C, Interleukin 28B

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).

Interventions

GENETICInterleukin 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)

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sustained virological response after living donor liver transplant12-24 monthsDetermine 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

MeasureTime frameDescription
Liver retransplantation1-24 monthsDetermine the need of liver retransplantion based on the IL 28B genotype

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026