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

NCT01429155 | Completed DMC

• 1 other identifier: 6975
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Liver retransplantation

  1-24 months

Study Arms (2)

Liver transplant recipeints

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

Genetic: Interleukin 28B genotype

Liver Donors

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

Genetic: Interleukin 28B genotype

Interventions

Interleukin 28B genotype 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; Liver transplant recipeints

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who are not willing to sign the consent
• Inability to obtain liver specimen (recipients)
• Inability to obtain blood sample (donors)

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related 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.

  PMID: 21254179 BACKGROUND

• 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.

  PMID: 21384511 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Hepatitis C; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency

Study Officials

• Humberto C Gonzalez, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 5, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)