Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

NCT ID: NCT04203875

Last Updated: 2021-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2020-07-23

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.

Conditions

Autoimmune Hepatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orencia® (Abatacept)

Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response

Group Type: EXPERIMENTAL

Orencia® (Abatacept)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stuart Knechtle, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Stuart Knechtle, M.D.

Transplant Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stuart Knechtle, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00102357

Identifier Type: -

Identifier Source: org_study_id