Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04203875
Other study ID # Pro00102357
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date March 9, 2020
Est. completion date July 23, 2020

Study information

Verified date November 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 1
Est. completion date July 23, 2020
Est. primary completion date July 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Stuart Knechtle, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events as reported Any Adverse Event within 56 days of last dose
Primary Number of Infections seen after administration Any infection within 56 days of last dose
Primary Number of malignancies reported any malignancy within 56 days of last dose
Secondary A change in aspartate aminotransferase (AST) Any change Baseline and at 6 weeks after start of administration
Secondary A change in alanine aminotransferase (ALT) Any change Baseline and at 6 weeks after start of administration
Secondary a change in alkaline phosphatase Any change Baseline and at 6 weeks after start of administration
Secondary Change in bilirubin Any change Baseline and at 6 weeks after start of administration
Secondary Change in liver biopsy evidence of AIH compared to pre-treatment evidence of worsening AIH on biopsy through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06020976 - Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital
Recruiting NCT05476900 - A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06250309 - Mediterranean Diet Versus Western Diet on Fatigue in Autoimmune Hepatitis Patients N/A
Recruiting NCT01661842 - Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis Phase 1/Phase 2
Terminated NCT04339621 - AIH Risk Stratification With Multiparametric MRI
Not yet recruiting NCT04371718 - Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) Phase 2
Completed NCT02239562 - sPIF CLINICAL STUDY PROTOCOL IN AUTOIMMUNE HEPATITIS Phase 1
Recruiting NCT05569759 - A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) Phase 2
Completed NCT02463331 - Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis Phase 4
Not yet recruiting NCT06356506 - A Study on Factors of Biochemical Response in Autoimmune Hepatitis
Recruiting NCT06078098 - Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
Completed NCT00838214 - Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis Phase 2/Phase 3
Recruiting NCT05810480 - PredIcting sterOid depeNdEnt livEr injuRy With Polyreactive Immunoglobulin G
Recruiting NCT03743272 - Repeatability and Reproducibility of Multiparametric MRI
Completed NCT03979053 - Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
Not yet recruiting NCT04902807 - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Recruiting NCT04933292 - A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome Phase 4
Not yet recruiting NCT06455280 - SIPLIZUMAB in AILD and LT Phase 1
Completed NCT05532345 - Discrimination of DILI and AIH by Artificial Intelligence