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Clinical Trial Summary

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00379483
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date July 2002
Completion date April 2003

See also
  Status Clinical Trial Phase
Completed NCT00560820 - Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload Phase 1
Completed NCT00390858 - A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload. Phase 2
Completed NCT01039636 - Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload Phase 1
Completed NCT00600938 - Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload Phase 2
Completed NCT00673608 - Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload Phase 4
Withdrawn NCT01927913 - Treatment of Iron Overload Requiring Chelation Therapy Phase 2
Completed NCT01241357 - High-Tc Susceptometer to Monitor Transfusional Iron Overload Phase 2
Completed NCT01838291 - Active Drug Surveillance Program of Ferriprox Use N/A
Completed NCT01044186 - A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity Phase 2
Terminated NCT01326845 - Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study Phase 4
Completed NCT01186419 - Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload Phase 2
Terminated NCT01363908 - Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload Phase 2