Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis
- Registration Number
- NCT04203875
- Lead Sponsor
- Stuart Knechtle, M.D.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orencia® (Abatacept) Orencia® (Abatacept) Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response
- Primary Outcome Measures
Name Time Method Number of Adverse Events as reported within 56 days of last dose Any Adverse Event
Number of Infections seen after administration within 56 days of last dose Any infection
Number of malignancies reported within 56 days of last dose any malignancy
- Secondary Outcome Measures
Name Time Method A change in aspartate aminotransferase (AST) Baseline and at 6 weeks after start of administration Any change
A change in alanine aminotransferase (ALT) Baseline and at 6 weeks after start of administration Any change
a change in alkaline phosphatase Baseline and at 6 weeks after start of administration Any change
Change in bilirubin Baseline and at 6 weeks after start of administration Any change
Change in liver biopsy evidence of AIH compared to pre-treatment through study completion, an average of 1 year evidence of worsening AIH on biopsy
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States