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.

Transfusional Iron Overload Clinical Trial

Official title:
A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major.

Status Completed

Clinical Trial Summary

In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.

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

Clinical Trial Details

NCT number	NCT00390858
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 2
Start date	September 2003
Completion date	February 2008

View Details

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	`NCT01039636` - Safety and Pharmacokinetic Study of Escalating Multiple Doses of an Iron Chelator in Patients With Iron Overload	Phase 1
Completed	`NCT00673608` - Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload	Phase 4
Completed	`NCT00600938` - Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload	Phase 2
Withdrawn	`NCT01927913` - Treatment of Iron Overload Requiring Chelation Therapy	Phase 2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
Completed	`NCT00379483` - Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload	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