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

• Status: Completed
• Trial end date: 2021-02-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Icahn School of Medicine at Mount Sinai; Mount Sinai Hospital, New York
• Treatments: Epoetin Alfa

Criteria

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