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

Primary Purpose

Autoimmune Hepatitis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autoimmune Hepatitis

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medicine
  • Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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

Outcomes

Primary Outcome Measures

Change in number of regulatory T cells
Calculated relative to baseline collected at time of enrollment

Secondary Outcome Measures

Change in number of effector T cells after a single dose of erythropoietin
Calculated relative to baseline collected at time of enrollment
Change in cytokine production by the T cells in response to ex vivo stimulation
Calculated relative to baseline collected at time of enrollment

Full Information

First Posted
February 12, 2019
Last Updated
March 2, 2021
Sponsor
Northwestern University
Collaborators
Mount Sinai Hospital, New York, Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03842254
Brief Title
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
Official Title
Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Mount Sinai Hospital, New York, Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
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 same thing in adults with autoimmune hepatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Intervention Description
Subcutaneous injection of erythropoietin 10,000 units
Primary Outcome Measure Information:
Title
Change in number of regulatory T cells
Description
Calculated relative to baseline collected at time of enrollment
Time Frame
At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Secondary Outcome Measure Information:
Title
Change in number of effector T cells after a single dose of erythropoietin
Description
Calculated relative to baseline collected at time of enrollment
Time Frame
At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Title
Change in cytokine production by the T cells in response to ex vivo stimulation
Description
Calculated relative to baseline collected at time of enrollment
Time Frame
At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33721837
Citation
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. Erratum In: J Autoimmun. 2021 Jul;121:102665.
Results Reference
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Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease

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