EUCTR2009-010088-17-IT进行中（未招募）不适用
Whole liver iron overload measured by the biosusceptometer Magnetic Iron Detector (MID) in thalassemia and MDS patients treated with deferasirox - ND
AZIENDA OSPEDALIERA OSPEDALI GALLIERA0 个研究点开始时间: 2009年4月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Diagnosis of thalassemia major with iron overload or regularly transfused MDS patients (Low/Intermediate-1 IPSS risk and 1 year life expectancy)
- •M/F adult patients (age ≥18 years)
- •Patients starting/about to start or potentially eligible to the treatment with deferasirox according to locally approved label
- •Female patients who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
- •Written informed consent by the patient in accordance with the national legislation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non transfusional hemosiderosis
- •Renal impairment and/or with estimated creatinine clearance <60 ml/min at baseline
- •Serum creatinine above the upper limit of normal range at screening
- •Significant proteinuria as indicated by urinary protein/creatinine ratio ≥ 1 in a non-first void urine sample at baseline
- •History of nephrotic syndrome
- •Severe liver impairment and/or ALT (SGPT) and AST (SGOT) >5 ULN
- •Patients with uncontrolled systemic hypertension
- •Pregnant or breast feeding patients
- •Hypersensitivity to the active substance or to any of the excipients
- •Concomitant use of other iron chelating agents
- •History of clinically relevant ocular and auditory toxicity related to iron chelation therapy
- •Heart function: Left Ventricular Ejection Fraction (LEF) <50% assessed by echo or <60% by MRI and/or T2* <10 ms measured in the last year
- •Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing study treatment
- •Patients unable to undergo study assessments including MRI and MID e.g. patients who are claustrophobic to MRI or have metallic prostheses not compatible with both MRI and MID procedures or patients who are obese (exceeding the equipment limits of MRI)
- •Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days. Patients being treated with experimental drugs for MDS, including thalidomide or analogues, azacitidine in the previous four weeks. These patients are eligible after a minimum washout period of four weeks
- •Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as the following:
- •- history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding
- •- history of major gastrointestinal tract surgery such as gastrectomy, gastro-enterostomy or bowel resection
- •- history of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- •- history or presence of impaired renal function as indicated by creatinine or blood urea nitrogen (BUN) values equal or above ULN
- •- history of urinary obstruction or difficulty in voiding
- •History of drug or alcohol abuse
- •Patients with positive test to HIV
- •History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
- •Patient unwilling to comply with the protocol
研究者
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