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.
Participants in this study will receive the study drug once a week for 6 months. If the study doctor feels the study drug has been beneficial, participants may receive additional study drug doses for up to an additional 6 months. Participants will continue on follow-up for 1 year after stopping Abatacept. The risks related to participation in this study include potential side effects from the study drug include infusion-related reactions (reactions at the injection site), increase in respiratory adverse events, infections in patients with chronic obstructive pulmonary disease, risk of development of malignancies (cancer) or autoimmune disorders (which may make your current autoimmune disease worse or you can contract new autoimmune diseases). It is unknown if this is drug related. The study doctor will discuss any concerns about this with you prior to receiving treatment. There is the possibility that the participant may experience improvement in their medical condition from participation in this study. However, this benefit cannot be guaranteed. There may be no direct medical benefit to the participant due to their participation. The Investigator hopes that in the future the information learned from this study will benefit other people with this condition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Orencia® (Abatacept) will be administered once a week for 6 months subcutaneously (injection under the skin) with an option to continue to receive Abatacept weekly injections for an additional 6 months, for a total of 12 months if there is a positive response.
Duke University Medical Center
Durham, North Carolina, United States
Number of Adverse Events as reported
Any Adverse Event
Time frame: within 56 days of last dose
Number of Infections seen after administration
Any infection
Time frame: within 56 days of last dose
Number of malignancies reported
any malignancy
Time frame: within 56 days of last dose
A change in aspartate aminotransferase (AST)
Any change
Time frame: Baseline and at 6 weeks after start of administration
A change in alanine aminotransferase (ALT)
Any change
Time frame: Baseline and at 6 weeks after start of administration
a change in alkaline phosphatase
Any change
Time frame: Baseline and at 6 weeks after start of administration
Change in bilirubin
Any change
Time frame: Baseline and at 6 weeks after start of administration
Change in liver biopsy evidence of AIH compared to pre-treatment
evidence of worsening AIH on biopsy
Time frame: through study completion, an average of 1 year
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