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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
Sponsor:
Information provided by (Responsible Party):
Stuart Knechtle, M.D., Duke University

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.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: Orencia® (Abatacept) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Adverse Events as reported [ Time Frame: within 56 days of last dose ]
    Any Adverse Event

  2. Number of Infections seen after administration [ Time Frame: within 56 days of last dose ]
    Any infection

  3. Number of malignancies reported [ Time Frame: within 56 days of last dose ]
    any malignancy


Secondary Outcome Measures :
  1. A change in aspartate aminotransferase (AST) [ Time Frame: Baseline and at 6 weeks after start of administration ]
    Any change

  2. A change in alanine aminotransferase (ALT) [ Time Frame: Baseline and at 6 weeks after start of administration ]
    Any change

  3. a change in alkaline phosphatase [ Time Frame: Baseline and at 6 weeks after start of administration ]
    Any change

  4. Change in bilirubin [ Time Frame: Baseline and at 6 weeks after start of administration ]
    Any change

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: On-Call Research Team 919-970-1234 AbdominalTransplant-ClinicalResearchStaff@duke.edu
Contact: Stuart Knechtle, MD 919-613-6133 stuart.knechtle@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27720
Contact: Stuart Knechtle, MD    919-613-6133    stuart.knechtle@duke.edu   
Sponsors and Collaborators
Stuart Knechtle, M.D.
Investigators
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Principal Investigator: Stuart Knechtle, MD Duke University
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Responsible Party: Stuart Knechtle, M.D., Transplant Surgeon, Duke University
ClinicalTrials.gov Identifier: NCT04203875    
Other Study ID Numbers: Pro00102357
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD at this time

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents