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

NCT03842254 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STU00206077
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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 then the investigators will collect blood at different time points for analysis of regulatory T cell number and function.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in number of effector T cells after a single dose of erythropoietin

  At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.

• Change in cytokine production by the T cells in response to ex vivo stimulation

  At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.

Study Arms (1)

Single arm

EXPERIMENTAL

Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment.

Drug: Erythropoietin

Interventions

Erythropoietin DRUG

Subcutaneous injection of erythropoietin 10,000 units

Single arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwestern University: lead
• Mount Sinai Hospital, New York: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• McEachern E, Carroll AM, Fribourg M, Schiano TD, Hartzell S, Bin S, Cravedi P, Levitsky J. Erythropoietin administration expands regulatory T cells in patients with autoimmune hepatitis. J Autoimmun. 2021 May;119:102629. doi: 10.1016/j.jaut.2021.102629. Epub 2021 Mar 13.

  PMID: 33721837 DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Surgery

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: January 25, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

US (2)