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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2021-02-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autoimmune Hepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Single arm

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

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

Subcutaneous injection of erythropoietin 10,000 units

Interventions

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Erythropoietin

Subcutaneous injection of erythropoietin 10,000 units

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No