Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00564941
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 28, 2007
First Posted Date  ICMJE November 29, 2007
Last Update Posted Date February 24, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Change History Complete list of historical versions of study NCT00564941 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2007)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Official Title  ICMJE Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
Brief Summary This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelodysplastic Syndromes
  • Beta-Thalassemia
Intervention  ICMJE Drug: deferasirox
Other Name: ICL670
Study Arms  ICMJE Experimental: Deferasirox
Intervention: Drug: deferasirox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 28, 2007)
309
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00564941
Other Study ID Numbers  ICMJE CICL670AHU02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2017

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