Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04203875|
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : March 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Hepatitis||Drug: Orencia® (Abatacept)||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis|
|Actual Study Start Date :||March 9, 2020|
|Estimated Primary Completion Date :||December 20, 2021|
|Estimated Study Completion Date :||December 20, 2023|
Experimental: Orencia® (Abatacept)
Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response
Drug: Orencia® (Abatacept)
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.
- Number of Adverse Events as reported [ Time Frame: within 56 days of last dose ]Any Adverse Event
- Number of Infections seen after administration [ Time Frame: within 56 days of last dose ]Any infection
- Number of malignancies reported [ Time Frame: within 56 days of last dose ]any malignancy
- A change in aspartate aminotransferase (AST) [ Time Frame: Baseline and at 6 weeks after start of administration ]Any change
- A change in alanine aminotransferase (ALT) [ Time Frame: Baseline and at 6 weeks after start of administration ]Any change
- a change in alkaline phosphatase [ Time Frame: Baseline and at 6 weeks after start of administration ]Any change
- Change in bilirubin [ Time Frame: Baseline and at 6 weeks after start of administration ]Any change
- Change in liver biopsy evidence of AIH compared to pre-treatment [ Time Frame: through study completion, an average of 1 year ]evidence of worsening AIH on biopsy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203875
|Contact: On-Call Research Team||919-970-1234||AbdominalTransplant-ClinicalResearchStaff@duke.edu|
|Contact: Stuart Knechtle, MDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27720|
|Contact: Stuart Knechtle, MD 919-613-6133 firstname.lastname@example.org|
|Principal Investigator:||Stuart Knechtle, MD||Duke University|