Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease

ID#: NCT03842254

Age: 18 - 74 years

Gender: All

Healthy Subjects: No

Study Phase: Early Phase 1

Recruitment Status: Enrolling by invitation

Start Date: January 25, 2019

End Date: October 01, 2019

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.

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