De Novo Autoimmune Hepatitis in Pediatric Liver Transplantation

Summary

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.

Conditions

• De Novo Autoimmune Hepatitis

Interventions

OTHER

Pediatric transplant subject with d-AIH

30 ml of blood will be collected during periods of disease quiescence and activity in recipients with d-AIH who are enrolled. The exact number of blood draws will depend on the patient's pattern of disease activity. No more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2 year study period will be 8.

OTHER

Pediatric transplant subject with acute rejection

Recipients with acute rejection will have blood drawn at time of diagnosis before treatment for rejection is instituted.

OTHER

Pediatric transplant subject with chronic rejection

Recipients with chronic rejection will have blood drawn either at diagnosis before treatment is instituted or for those with ongoing chronic rejection at the time of enrollment.

OTHER

Adult non-transplant patients with auto-immune hepatitis

75 ml of blood will be collected during periods of disease quiescence and activity in non transplanted subjects with AIH who are enrolled. Research blood draws will be drawn along with clinical blood draws. The exact number of blood draws for each subject will depend on his or her pattern of disease activity. No more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2 year study period will be 8. Liver tissue (2 mm) will be obtained at the time a clinically indicated liver biopsy is performed. In the event that any enrolled subject undergoes liver transplantation, a portion of the explanted liver will be obtained and stored in special media.

OTHER

Adult non-transplant subjects with chronic hepatitis C virus

For enrolled patients with chronic hepatitis C, 75 ml of blood will be collected before the start of treatment. This will be a onetime blood draw prior to treatment. Liver tissue (2 mm) will be obtained at the time a clinically indicated liver biopsy is performed. In the event that any enrolled patient undergoes liver transplantation, a portion of the explanted liver will be obtained and stored in special media.

OTHER

Pediatric control subjects

2 tablespoons of blood (30 ml) will be collected at each blood draw over a 2-year period. . The maximum amount of blood draws will be 3 however there will be no more than 1 blood draw within an 8-week period.

OTHER

Adult transplanted subjects with de novo autoimmune hepatitis

75 ml of blood will be collected during periods of disease quiescence and activity in recipients with d-AIH who are enrolled. The exact number of blood draws for each subject will depend on his or her pattern of disease activity. However, no more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2-year study period will be 8.

Sponsors & Collaborators

• Yale University

  lead OTHER

Principal Investigators

• Udeme Ekong, MD, MPH · Yale University

Eligibility

Min Age

3 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-09

Primary Completion

2019-11-25

Completion

2019-11-25