Autoimmune HepatitisPhase 1NCT04203875
Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis
A Phase 1 study testing Orencia® (Abatacept) in people with Autoimmune Hepatitis, run by Stuart Knechtle, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Orencia® (Abatacept)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 23 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27720
About this study
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.
Read the 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
- Being tested
- Orencia® (Abatacept)
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Orencia® (Abatacept) | Experimental | Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response Receives: Drug: Orencia® (Abatacept) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events as reported
Any Adverse Event
Measured: within 56 days of last dose
Number of Infections seen after administration
Any infection
Measured: within 56 days of last dose
Number of malignancies reported
any malignancy
Measured: within 56 days of last dose
Secondary outcomes (5)
A change in aspartate aminotransferase (AST)
Any change
Measured: Baseline and at 6 weeks after start of administration
A change in alanine aminotransferase (ALT)
Any change
Measured: Baseline and at 6 weeks after start of administration
a change in alkaline phosphatase
Any change
Measured: Baseline and at 6 weeks after start of administration
Change in bilirubin
Any change
Measured: Baseline and at 6 weeks after start of administration
Change in liver biopsy evidence of AIH compared to pre-treatment
evidence of worsening AIH on biopsy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start9 Mar 2020
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Why it stopped: Lack of eligible study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart Knechtle, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stuart Knechtle, M.D., Duke University
- Investigators
- Stuart Knechtle, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203875
- Sponsor's protocol ID
- Pro00102357
- Status last verified
- Nov 2021
- First submitted
- 12 Dec 2019
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD at this time
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept for Treatment of Recurrent or de Novo Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT04203875
- Acronym / sponsor ID
- Pro00102357
- Conditions
- Autoimmune Hepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible study participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stuart Knechtle, M.D.University, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orencia® (Abatacept) | Experimental | Drug: Orencia® (Abatacept)Abatacept 125 mg, subcutaneous once a week for 6 months or up to one year if subject has a favorable response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Orencia® (Abatacept) |
Primary outcome
Number of Adverse Events as reported
Time frame: within 56 days of last dose
Any Adverse Event
Number of Infections seen after administration
Time frame: within 56 days of last dose
Any infection
Number of malignancies reported
Time frame: within 56 days of last dose
any malignancy
5 secondary outcomes
A change in aspartate aminotransferase (AST)
Time frame: Baseline and at 6 weeks after start of administration
A change in alanine aminotransferase (ALT)
Time frame: Baseline and at 6 weeks after start of administration
a change in alkaline phosphatase
Time frame: Baseline and at 6 weeks after start of administration
Change in bilirubin
Time frame: Baseline and at 6 weeks after start of administration
Change in liver biopsy evidence of AIH compared to pre-treatment
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Lack of eligible study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No. There are no plans to share IPD at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Knechtle, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orencia® (Abatacept) in people with Autoimmune Hepatitis, run by Stuart Knechtle, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of eligible study participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events as reported (time frame: within 56 days of last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.