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Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

Primary Purpose

Autoimmune Hepatitis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Orencia® (Abatacept)

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orencia® (Abatacept)

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Adverse Events as reported

Any Adverse Event

Number of Infections seen after administration

Any infection

Number of malignancies reported

any malignancy

Secondary Outcome Measures

A change in aspartate aminotransferase (AST)

Any change

A change in alanine aminotransferase (ALT)

Any change

a change in alkaline phosphatase

Any change

Change in bilirubin

Any change

Change in liver biopsy evidence of AIH compared to pre-treatment

evidence of worsening AIH on biopsy

Full Information

NCT ID

NCT04203875

First Posted

December 12, 2019

Last Updated

November 17, 2021

Sponsor

Stuart Knechtle, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT04203875

Brief Title

Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

Official Title

Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

Lack of eligible study participants.

Study Start Date

March 9, 2020 (Actual)

Primary Completion Date

July 23, 2020 (Actual)

Study Completion Date

July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stuart Knechtle, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Hepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Orencia® (Abatacept)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Orencia® (Abatacept)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Adverse Events as reported

Description

Any Adverse Event

Time Frame

within 56 days of last dose

Title

Number of Infections seen after administration

Description

Any infection

Time Frame

within 56 days of last dose

Title

Number of malignancies reported

Description

any malignancy

Time Frame

within 56 days of last dose

Secondary Outcome Measure Information:

Title

A change in aspartate aminotransferase (AST)

Description

Any change

Time Frame

Baseline and at 6 weeks after start of administration

Title

A change in alanine aminotransferase (ALT)

Description

Any change

Time Frame

Baseline and at 6 weeks after start of administration

Title

a change in alkaline phosphatase

Description

Any change

Time Frame

Baseline and at 6 weeks after start of administration

Title

Change in bilirubin

Description

Any change

Time Frame

Baseline and at 6 weeks after start of administration

Title

Change in liver biopsy evidence of AIH compared to pre-treatment

Description

evidence of worsening AIH on biopsy

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Knechtle, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27720

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There are no plans to share IPD at this time

Learn more about this trial

Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

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