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

Transfusional Iron Overload Clinical Trial

Official title:
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

Status Completed

Clinical Trial Summary

The purpose of this open-label, non-comparative, multi-center protocol was to further evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of life threatening complications due to transfusional iron overload with a documented inability to tolerate any of the commercially available iron chelators due to severe toxicity rendering continued therapy either impossible or hazardous. Patients who were also ineligible for all on-going registration trials with ICL670 were included in the study. In exceptional cases, patients with a degree of iron overload which was not immediately life-threatening and who were ineligible for the registration trials were also enrolled provided they had a well-documented, sound justification for alternative chelation therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01044186
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 2
Start date	June 2003

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	`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Withdrawn	`NCT01927913` - Treatment of Iron Overload Requiring Chelation Therapy	Phase 2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	`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