Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

• Status: Recruiting
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether Orencia® (Abatacept) improves outcomes in liver transplant patients with recurrent or de novo AIH (autoimmune hepatitis) that has not responded to previous therapy. AIH that does not respond to steroids or conventional immunotherapy often affects young patients and leads to irreversible liver damage. There is currently no effective therapy for this condition.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stuart Knechtle, M.D.
• Treatments: Abatacept

Criteria

Inclusion Criteria for de novo AIH

• Age 18 or older

• Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and a different pre-transplant etiology of liver disease will be eligible.

• Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible.

• Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure.

• Women of child bearing potential agree to have pregnancy test at screening

• Males agree use of appropriate contraceptives during the active Orenia dosing period

Inclusion Criteria for recurrent AIH

• Age 18 or older

• Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and whose original etiology of liver disease was AIH will be eligible.

• Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible.

• Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure.

• Women of child bearing potential agree to have pregnancy test at screening

• Males agree use of appropriate contraceptives during the active Orenia dosing period

Exclusion Criteria:

• Active systemic infection

• Allergy to abatacept

• Known malignancy in the previous 2 years except for non-melanoma skin cancer

• Pregnancy or breast feeding

• Inability to commit to complete treatment protocol at Duke, as all procedures must be completed at Duke

• Prisoners or those who are compulsory detained

• Inability to read and understand English

• EBV seronegative (if not tested within 2 years prior to study enrollment, then testing will be done prior to study enrollment, results must be positive for study participation)