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Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00565578
First received: November 29, 2007
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

November 29, 2007
November 29, 2012
July 2006
May 2009   (final data collection date for primary outcome measure)
To Evaluate if fixed starting dose of ICL670, based on transfusional history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin [ Time Frame: Monthly ] [ Designated as safety issue: No ]
To Evaluate if fixed starting dose of ICL670, based on transfusional history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin
Complete list of historical versions of study NCT00565578 on ClinicalTrials.gov Archive Site
Safety assessed by serum Ferritin Tolerability assessed by safety profile Evaluate the relationship between serum ferritin and potential surrogate markers [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Safety assessed by serum Ferritin Tolerability assessed by safety profile Evaluate the relationship between serum ferritin and potential surrogate markers
Not Provided
Not Provided
 
Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload
A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-Dependent Iron Overload

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Transfusion-Dependent Iron Overload
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
282
Not Provided
May 2009   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients presenting with transfusion-dependent anemias (independent of underlying condition) with transfusional iron overload as shown by a serum ferritin level of ≥ 1000 ng/ml
  • Patients of either gender and aged ≥ 2 years
  • Female patients who have reached menarche and 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.

Exclusion criteria:

  • Non-transfusional hemosiderosis
  • Patients with clinical evidence supporting the need for intensive chelation, base on the investigator's judgment
  • Patients with mean levels of Alanine aminotransferase (ALT) >300 U/l
  • Patients with uncontrolled systemic hypertension
  • Patients with serum creatinine above the upper limit of normal (ULN)

Other protocol-defined inclusion/exclusion criteria may apply.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00565578
CICL670A2409E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
Novartis
November 2012

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