Status:
COMPLETED
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Mount Sinai Hospital, New York
Icahn School of Medicine at Mount Sinai
Conditions:
Autoimmune Hepatitis
Eligibility:
All Genders
18-74 years
Phase:
EARLY_PHASE1
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03842254
Start Date
January 25 2019
End Date
February 18 2021
Last Update
March 4 2021
Active Locations (2)
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1
Northwestern Medicine
Chicago, Illinois, United States, 60611
2
Mount Sinai
New York, New York, United States, 10029