EUCTR2007-004008-10-HU进行中（未招募）不适用
Evaluating the efficacy of Exjade® (deferasirox) in transfusion dependent chronic anaemias ( Myelodysplasia Syndrome, Beta-thalassaemia major patients) with chronic iron overload
ovartis Hungária Kft.0 个研究点开始时间: 2007年10月17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
- •In- or outpatients with myelodysplasia / with risk of low or intermedier-1 according to the International Prognostic Scoring System (IPSS) confirmed by bone marrow evaluation within 3 month/ or beta thalassaemia major patients, who have chronic iron overload, as a consequence of frequent blood transfusion
- •Serum ferritin> 1800 µg/L
- •Age: 18-80 years
- •Chronic iron overload caused by at least 30 units and maximum 100 units of blood
- •of packed red blood cells
- •Deferoxamin (Desferal®) therapy is contraindicated or inadequate or unable to use in the recommended dose due to intolerability or other reason
- •ECOG performance status score between 0-2
- •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
- •beta thalassaemia minor,
- •haemosiderosis caused by other than chronic transfusional iron overload,
- •patients with impaired renal function (Creatinin clearance< 60 ml/ min),
- •pregnancy,
- •lactation,
- •patient of childbearing potencial unwilling to use contraceptive precautions
- •known hypersensitivity to Exjade or any ingredients,
- •impaired hepatic function (SGOT,SGPT 5x above UNL).
- •Patients severely ill due to underlying disease progression or other severe concomitant disease.
- •Patients participated in other clinical trial 30 days prior enrollment.
- •Patients with poor prognosis of karyotype according to the IPSS
- •ECOG performance status score above 2
- •patients with malabsorption caused by inflammatory bowel disease, gastrectomy, pancreatitis or other medical condition
- •History of nephrotic syndrome
- •Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 (mg/mg) in second-voiding urine samples taken at either visits 1 or 2.
- •History of non-compliance to medical regimens
- •Patients with positive test to HIV
- •Life expectancy of < 1year
研究者
相似试验
进行中（未招募）
不适用
Early treatment with deferasirox (Exjade®) in low risk MDS - Exjade-Early-TrialPatients presenting with low or INT-1 risk MDS with only mild iron overload will be treated with deferasirox in this study. It will be analyzed if hematological improvement can be observed during this treatment.EUCTR2008-006268-12-DEFriedrich-Alexander-Universitaet Erlangen-Nuernberg
已完成
2 期
Effect of Osveral on iron overload in beta thalassemia major patients.beta thalassemia.beta thalassemiaIRCT2015102524679N2Investigator69
进行中（未招募）
不适用
Phase I study to examine the effect of deferasirox on renal hemodynamics in β-thalassemia patients with transfusional iron overload - NDMedDRA version: 6.1Level: HLGTClassification code 10022958thalassemiaEUCTR2006-006838-17-ITOVARTIS FARMA8
招募中
不适用
Comparison of efficacy and safety of exenatide extended-release and dulaglutide in type 2 diabetes mellitus patients who are insufficiently controlled with oral antidiabetic agentsType 2 diabetes mellitusJPRN-UMIN000019096Haga Diabetes Clinic75
进行中（未招募）
1 期
EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI.MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersEUCTR2016-002683-14-NLDaiichi Sankyo Europe GmbH1,506