Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic… (NCT00564941) | Clinical Trial Compass
CompletedPhase 4
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Hungary309 participantsStarted 2007-12
Plain-language summary
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria:
* 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
* men and women
* Chronic iron overload caused by at least 30 units and maximum 100 units of blood of packed red blood cells
* Deferoxamin therapy is contraindicated or inadequate or unable to use in the recommended dose due to intolerability or other reason
* Eastern Cooperative Oncology Group (ECOG) performance status score between 0-2
* written informed consent
Exclusion criteria:
* 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 potential unwilling to use contraceptive precautions
* known hypersensitivity to deferasirox 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 with poor prognosis of karyotype
* patients with malabsorption caused by inflammatory bowel disease, gastrectomy, pancreatitis or other medical condition
* History of nephrotic syndrome
* Significant proteinuria
* Patients wit…
What they're measuring
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This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Timeframe: monthly during the therapy and at the end of the treatment (aftr 9 months therapy)