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

This study is currently recruiting participants.
Verified September 2011 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Humberto C. Gonzalez, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01429155
First received: September 2, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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).


Condition Intervention
Hepatitis C
 Genetic: Interleukin 28B genotype

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post Transplant Course of Hepatitis C Patients After Living Donor Liver Transplant in Association With Interleukin 28 B

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Sustained virological response after living donor liver transplant [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Liver retransplantation [ Time Frame: 1-24 months ] [ Designated as safety issue: No ]
    Determine the need of liver retransplantion based on the IL 28B genotype


Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Liver transplant recipeints
Patients suffering from chronic hepatitis C that required a living donor liver transplant.
 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 Donors
Patients who donated part of their liver to a patient suffering from chronic 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429155

Contacts
Contact: Humberto C Gonzalez, MD 313-916-2424 hgonzal1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Humberto C Gonzalez, MD     313-916-2424     hgonzal1@hfhs.org    
Contact: Margaret French, RN     313-916-3369     mfrench1@hfhs.org    
Principal Investigator: Humberto C Gonzalez, MD            
Sub-Investigator: Stuart C Gordon, MD            
Sub-Investigator: Kristin G Monaghan, PhD            
Sub-Investigator: Adrian Ormbsy, MD            
Sub-Investigator: Lois Lamerato, PhD            
Sub-Investigator: Marwan Abouljoud, MD            
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Humberto C Gonzalez, MD Henry Ford Hospital
  More Information

Publications:

Responsible Party: Humberto C. Gonzalez, Gastroenterology Fellow, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01429155     History of Changes
Other Study ID Numbers: 6975
Study First Received: September 2, 2011
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
End stage liver disease
Living donor liver transplantation
Hepatitis C
Interleukin 28B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013