Autoimmune Hepatitis
Conditions
Brief 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.
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.
Interventions
DRUGErythropoietin
Subcutaneous injection of erythropoietin 10,000 units
Sponsors
Mount Sinai Hospital, New York
Icahn School of Medicine at Mount Sinai
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of regulatory T cells | At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. | Calculated relative to baseline collected at time of enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of effector T cells after a single dose of erythropoietin | At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. | Calculated relative to baseline collected at time of enrollment |
| Change in cytokine production by the T cells in response to ex vivo stimulation | At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks. | Calculated relative to baseline collected at time of enrollment |
Countries
United States
Outcome results
None listed