Use of Erythropoietin to Expand Regulatory T Cells in Autoimmune Liver Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in number of regulatory T cells
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single arm
Single dose of erythropoietin 10,000 units to be administered subcutaneously at time of enrollment.
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Change in number of regulatory T cells
时间窗: At time of enrollment, then at 2 weeks, 4 weeks, and 12 weeks.
Calculated relative to baseline collected at time of enrollment
次要结局
- 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.)
研究者
Josh Levitsky
Professor of Medicine and Surgery
Northwestern University