DRKS00010424招募中1 期
A Phase I-IIa trial on low-dose IL-2 (Aldesleukin) treatment for immunological dysregulation in common variable immunodeficiency (CVID) - REGAIN: REGulatory T cells and Aldesleukin for Immunodeficiency- associated eNteropathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Patient with a diagnosis of CVID according to the ESID/PAGID criteria
- •2.Sufficient IgG replacement therapy for at least 6 months with IgG trough levels above 6g/l.
- •3.Diagnosis of autoimmune enteropathy of the upper gastrointestinal tract proven by histology. Last biopsy <6 months before study inclusion.
- •4.Clinical activity of enteropathy within the last month before inclusion defined as = 3 loose stools per day on more than half of the days.
- •5.Report of negative culture for pathogenic intestinal bacteria within one month before study inclusion.
- •6.Failure of topic or systemic steroid treatment or contraindications for steroid therapy or unacceptable side effects of steroid treatment.
- •7.Daily dose of glucocorticosteroids = 20mg prednisolone (or equivalent) at the day of baseline visit.
排除标准
- •1.Need for a scheduled application of contrast agent during the trial.
- •2.Patients with malignant neoplasm within the last 5 years prior to visit 1 (except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix).
- •3.Patients with an ECOG = 2.
- •4.Patients with a history of or current severe cardiac or pulmonary disease or uncontrolled pericardial or pleural effusion.
- •5.Patients with thrombosis or thromboembolic event < 6 months before study inclusion.
- •6.Patients with active CNS involvement (e.g. intracranial granulomata, multiple sclerosis, vasculitis or other autoinflammatory CNS disease) or recurrent seizures.
- •7.Uncontrolled chronic infectious disease (including HIV, EBV, CMV, HCV, HBV, tuberculosis) or conditions which represent a high risk for infection (i.e. severe bronchiectasis) which might interfere with the study at the discretion of the investigator.
- •8. Major infection requiring antibiotic therapy or infection requiring hospitalization within the last 4 weeks prior to the baseline visit.
- •9.Treatment with any immunosuppressive, cytotoxic drug within the last 4 weeks prior to visit 1 (except prednisolone = 20mg or equivalent).
- •10.Patients with allogenic organ transplants.
- •11.Active autoimmue manifestation requiring treatment (except autoimmune enteropathy).
- •12.Clinically relevant chronic or acute renal (creatinine >1.25 ULN), hepatic (AST > 3 ULN, bilirubin > 1.5 x ULN) or other severe organ impairment.
- •13.Preexisting cytopenia (hematocrit <30%, thrombocytes <100.000/µl, leukocytes <3.000/µl or neutrophils <1.500/µl or CD4 cell counts <100/ µl.
研究者
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