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

Autoimmune Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842254
• Other study ID #: STU00206077
• Status: Completed
• Phase: Early Phase 1
• Start date: January 25, 2019
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis, Autoimmune
• Liver Diseases

Intervention

Drug:
• Erythropoietin
Subcutaneous injection of erythropoietin 10,000 units

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois
United States	Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of regulatory T cells	Calculated relative to baseline collected at time of enrollment	At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Secondary	Change in number of effector T cells after a single dose of erythropoietin	Calculated relative to baseline collected at time of enrollment	At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Secondary	Change in cytokine production by the T cells in response to ex vivo stimulation	Calculated relative to baseline collected at time of enrollment	At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.