Autoimmune HepatitisEarly Phase 1NCT03842254
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
A Early Phase 1 study testing Erythropoietin in people with Autoimmune Hepatitis, run by Northwestern University at 2 sites in United States.
Trial summary
This study evaluates the effect of erythropoietin on the number and function of regulatory T cells in adults with autoimmune hepatitis. Participants will receive a single dose of erythropoietin, and then the investigators will collect blood at different time points for analysis of regulatory T cell number and function. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2019to 18 Feb 2021
- Phase
- Early 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of autoimmune liver diseases (autoimmune hepatitis, autoimmune cholangiopathy, or primary biliary cirrhosis or primary sclerosing cholangitis with hepatic autoimmune liver disease or overlap syndrome) confirmed on liver biopsy
- Use of immunosuppressive therapy (prednisone, azathioprine, 6-mercaptopurine, mycophenolate mofetil) for the treatment of the autoimmune liver disease
- Stable immunosuppression regimen at least 6 months prior to enrollment
- Ability to provide verbal and written informed consent
Who cannot join
- Diagnosis of decompensated cirrhosis (defined by presence of ascites, varices, encephalopathy)
- Hemoglobin above average normal value (15.7 g/dL in men, 13.8 g/dL in women)
- Alanine aminotransferase greater than 2 times upper limit of normal (33 IU/L in men and 25 IU/L in women)
- Uncontrolled hypertension with systolic blood pressure greater than or equal to 160 or diastolic blood pressure greater than or equal to 100
- End-stage renal disease on hemodialysis
- History of venous thromboembolism including deep vein thromboses or pulmonary emboli
Show all 20Show fewer
- History of stroke
- History of heart failure
- History of seizure disorder
- History of significant cardiovascular disease including a history of myocardial infarction
- Active malignancy (untreated or undergoing therapy)
- History of pure red cell aplasia
- History of intolerance or allergy to erythropoietin
- Known hypersensitivity to mammalian cell-derived products
- Known hypersensitivity to human albumin
- Presence of vascular access
- Prior recipient of erythropoietin within 12 weeks of the study
- Patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults
- Non-English speaking
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine
Chicago, Illinois, 60611
Mount Sinai
New York, New York, 10029
About this study
This study evaluates the effect of erythropoietin on the number and function of regulatory T cells in adults with autoimmune hepatitis. Participants will receive a single dose of erythropoietin, and then the investigators will collect blood at different time points for analysis of regulatory T cell number and function.
Read the detailed description
There is data from the laboratory that erythropoietin helps stimulate regulatory T cells, a type of immune cell which is thought to combat autoimmunity, but this study will look at whether it does the same thing in adults with autoimmune hepatitis.
- Conditions
- Autoimmune Hepatitis
- Being tested
- Erythropoietin
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Subcutaneous injection of erythropoietin 10,000 units
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment. Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of regulatory T cells
Calculated relative to baseline collected at time of enrollment
Measured: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Secondary outcomes (2)
Change in number of effector T cells after a single dose of erythropoietin
Calculated relative to baseline collected at time of enrollment
Measured: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Change in cytokine production by the T cells in response to ex vivo stimulation
Calculated relative to baseline collected at time of enrollment
Measured: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Jan 2019
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Josh Levitsky, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842254
- Sponsor's protocol ID
- STU00206077
- Status last verified
- Mar 2021
- First submitted
- 12 Feb 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
McEachern E, Carroll AM, Fribourg M, Schiano TD, Hartzell S, Bin S, Cravedi P, Levitsky J. Erythropoietin administration expands regulatory T cells in patients with autoimmune hepatitis. J Autoimmun. 2021 May;119:102629. doi: 10.1016/j.jaut.2021.102629. Epub 2021 Mar 13.
PubMed 33721837
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
- ClinicalTrials.gov ID
- NCT03842254
- Acronym / sponsor ID
- STU00206077
- Conditions
- Autoimmune Hepatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, Icahn School of Medicine at Mount Sinai
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 15 Feb 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.
This study evaluates the effect of erythropoietin on the number and function of regulatory T cells in adults with autoimmune hepatitis. Participants will receive a single dose of erythropoietin, and then the investigators will collect blood at different time points for analysis of regulatory T cell number and function.
Detailed description
There is data from the laboratory that erythropoietin helps stimulate regulatory T cells, a type of immune cell which is thought to combat autoimmunity, but this study will look at whether it does the same thing in adults with autoimmune hepatitis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: ErythropoietinSingle dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of autoimmune liver diseases (autoimmune hepatitis, autoimmune cholangiopathy, or primary biliary cirrhosis or primary sclerosing cholangitis with hepatic autoimmune liver disease or overlap syndrome) confirmed on liver biopsy
- Use of immunosuppressive therapy (prednisone, azathioprine, 6-mercaptopurine, mycophenolate mofetil) for the treatment of the autoimmune liver disease
- Stable immunosuppression regimen at least 6 months prior to enrollment
- Ability to provide verbal and written informed consent
Key exclusion criteria (20 listed)
- Diagnosis of decompensated cirrhosis (defined by presence of ascites, varices, encephalopathy)
- Hemoglobin above average normal value (15.7 g/dL in men, 13.8 g/dL in women)
- Alanine aminotransferase greater than 2 times upper limit of normal (33 IU/L in men and 25 IU/L in women)
- Uncontrolled hypertension with systolic blood pressure greater than or equal to 160 or diastolic blood pressure greater than or equal to 100
- End-stage renal disease on hemodialysis
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 |
|---|---|---|
| ErythropoietinSubcutaneous injection of erythropoietin 10,000 units | Drug | Single arm |
Primary outcome
Change in number of regulatory T cells
Time frame: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Calculated relative to baseline collected at time of enrollment
2 secondary outcomes
Change in number of effector T cells after a single dose of erythropoietin
Time frame: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Change in cytokine production by the T cells in response to ex vivo stimulation
Time frame: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Derived from this study: PubMed 33721837McEachern E, Carroll AM, Fribourg M, Schiano TD, Hartzell S, Bin S, Cravedi P, Levitsky J. Erythropoietin administration expands regulatory T cells in patients with autoimmune hepatitis. J Autoimmun. 2021 May;119:102629. doi: 10.1016/j.jaut.2021.102629. Epub 2021 Mar 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Erythropoietin in people with Autoimmune Hepatitis, run by Northwestern University at 2 sites 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 4 inclusion and 20 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: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in number of regulatory T cells (time frame: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842254, which also lists 1 linked publication.
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 4 Mar 2021.