Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00564941
First received: November 28, 2007
Last updated: September 8, 2011
Last verified: September 2011

November 28, 2007
September 8, 2011
December 2007
July 2011   (final data collection date for primary outcome measure)
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload [ Time Frame: monthly during the therapy and at the end of the treatment (aftr 9 months therapy) ] [ Designated as safety issue: No ]
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Complete list of historical versions of study NCT00564941 on ClinicalTrials.gov Archive Site
patient's compliance during the study assessed by the number of the unused tablets returned by the patient safety assessed by patient laboratory data, adverse events, serious adverse events [ Time Frame: during the treatment (9 months) ] [ Designated as safety issue: Yes ]
patient's compliance during the study assessed by the number of the unused tablets returned by the patient safety assessed by patient laboratory data, adverse events, serious adverse events
Not Provided
Not Provided
 
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload

This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myelodysplastic Syndromes
  • Beta-Thalassemia
Drug: deferasirox
Other Name: ICL670
Experimental: Deferasirox
Intervention: Drug: deferasirox
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
Not Provided
July 2011   (final data collection date for primary outcome measure)

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 with a previous history of clinically relevant ocular toxicity related to iron chelation
  • Patients with positive test to HIV

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT00564941
CICL670AHU02
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP