Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis

NCT04203875 | Terminated Phase 1 FDA Drug

• 1 other identifier: Pro00102357
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (3)

• Number of Adverse Events as reported

  Any Adverse Event

  within 56 days of last dose

• Number of Infections seen after administration

  Any infection

  within 56 days of last dose

• Number of malignancies reported

  any malignancy

  within 56 days of last dose

Secondary Outcomes (5)

• A change in aspartate aminotransferase (AST)

  Baseline and at 6 weeks after start of administration

• A change in alanine aminotransferase (ALT)

  Baseline and at 6 weeks after start of administration

• a change in alkaline phosphatase

  Baseline and at 6 weeks after start of administration

• Change in bilirubin

  Baseline and at 6 weeks after start of administration

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

  through study completion, an average of 1 year

Study Arms (1)

Orencia® (Abatacept)

EXPERIMENTAL

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

Drug: Orencia® (Abatacept)

Interventions

Orencia® (Abatacept) 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.

Orencia® (Abatacept)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stuart Knechtle, M.D.: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27720, United States

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Stuart Knechtle, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Transplant Surgeon

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 18, 2019
• Study Start: March 9, 2020
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)