Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
- Registration Number
- NCT03842254
- Lead Sponsor
- Northwestern University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Erythropoietin Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
Mount Sinai
🇺🇸New York, New York, United States