De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation

Trial Purpose and Description

The purpose of this study is to provide insights into the cause, development and effects of de novo autoimmune hepatitis so that prevention and treatment strategies can be developed in order to reduce post-liver transplant morbidity, the frequency of liver allograft loss and the need for re-transplantation.

Ages: 3 months and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

Pediatric Transplant Patients

  • Is >3-months and <21 years of age and a recipient of a single organ liver transplant
  • Has allograft dysfunction (an ALT and/or GGTP > 2 times the upper limit of normal) due to acute rejection without a prior diagnosis of d-AIH
  • Has allograft dysfunction (an ALT and/or GGT > 2 times the upper limit of normal) due to chronic rejection without a prior diagnosis of d-AIH
  • Has a diagnosis of d-AIH

Healthy Pediatric Control Subjects (Enrolled at Yale)

  • Is ≥ 1-year and < 18-years of age
  • Not on any immune modulators
  • Not on steroid therapy
  • Has no underlying chronic inflammatory condition

Adult Control Subjects (Enrolled at Yale) Non-transplanted Adult patients with autoimmune hepatitis and chronic hepatitis C will also be enrolled.

  • Non-transplanted adults "18 Years or > " with Autoimmune Hepatitis
  • Non-transplanted adults "18 Years or > " with chronic hepatitis C who are treatment naive.

Exclusion Criteria:

Pediatric Transplant Patients - Multi-visceral organ transplant recipient

Healthy Pediatric Control Subjects (Enrolled at Yale)

  • <1-year and > 18-years of age
  • Has chronic inflammatory condition
  • On immune modulators or steroids
  • On chronic medication(s)

Adult transplanted patients with d-AIH (enrolled at Yale)

- Transplanted Adults ≥21-years of age with a diagnosis of d-AIH


Yale University School of Medicine

Start Date: 03/15/2013

End Date: 12/12/2018

Last Updated: 03/07/2018

Study HIC#: 1302011561

Get Involved

For more information about this study, contact:
Danielle Paquette
+1 203-785-7526
danielle.paquette@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Udeme D Ekong

Principal Investigator

Sub-Investigators