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

Completed · Early Phase 1

Conditions studied: Autoimmune Hepatitis

In brief

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.

Key facts

Study ID

NCT03842254

Run by

Northwestern University

People needed

6

Starts

2019-01-25

Expected to finish

2021-02-18

Last updated by the study team

2021-03-04

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern Medicine — Chicago, Illinois, United States
• Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.