EUCTR2018-001469-18-IT进行中（未招募）1 期
Treatment of beta-thalassemia patients with rapamycin (sirolimus): from pre-clinical research to a clinical trial - THALA-RAP
Dipartimento di Scienze della Vita e Biotecnologie dell'Università degli Studi di Ferrara0 个研究点目标入组 30 人开始时间: 2021年5月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Responsive to the in vitro (ErPCs) treatment with sirolimus according to laboratory specific definition (= 20% increase of HbF in comparison with samples not treated with sirolimus);
- •2.AST or ALT < 3x ULN (Upper Limit of Normal);
- •3.Documented Platelet count >150.000/ul;
- •4.Patient willing to follow all the study requirements and perform all the study visits and to cooperate with the investigator;
- •5.Selection criteria must still be fulfilled at the time of the inclusion visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Uncontrolled hypertension defined as systolic pressure (PA) = 140 mm Hg or diastolic pressure = 90 mm Hg;
- •2.Class 3 or higher heart failure (New York Heart Association, NYHA);
- •3.QTc> 450 msec on selection ECG;
- •4.White blood cell [WBC] count <3000 cells per µL and/or Granulocytes <1500/mm3;
- •5.Total cholesterol > 240 mg/dl;
- •6.Triglycerides > 200 mg/dl;
- •7.Proteinuria with urinary protein >1g/24 hrs;
- •8.Any active infection requiring parenteral antibiotic therapy within 28 days prior to inclusion or oral antibiotics within 14 days prior to inclusion;
- •9.Enrolment into one other drug or device trial since selection;
- •10.Major surgery (including splenectomy) performed after the study selection visit;
- •11.Ongoing treatment with drugs and agents that could increase the concentration of sirolimus in the blood including: ciclosporin, bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors (eg for HIV and hepatitis C which require pharmacological treatment with ritonavir, indinavir, boceprevir and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil;
- •12.Ongoing treatment with drugs and agents that could reduce the concentration of sirolimus including carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's wort (Hypericum perforatum);
- •13.Cytotoxic agents, systemic corticosteroids, immunosuppressants or anticoagulant therapy such as warfarin or heparin within 28 days before inclusion (prophylactic aspirin up to 100 mg / day is allowed);
- •14.Macrolidic antibiotics (clarithromycin).
- •15.Occurrence of an event which leads to the appearance of a non-selection criteria.
研究者
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