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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00654589 |
The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.
Condition | Intervention | Phase |
---|---|---|
Iron Overload |
Drug: ICL670/Deferasirox |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A One-Year, Open-Label, Single Arm, Multi-Center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/Day) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present |
Estimated Enrollment: | 75 |
Study Start Date: | February 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis Basel | 41 61 324 1111 |
Germany | |
Universitätsklinikum Leipzig-AÖR | Recruiting |
Leipzig, Germany, 04103 | |
Contact: H-.K. Al-Ali, M.D. + 49-3 41- 97 -13 125 alah@medizin.uni-leipzig.de |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CICL670ADE02 |
Study First Received: | April 2, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00654589 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices (BfArM) |
Hematopoietic stem cell transplantation HCT iron overload chelators ICL670 deferasirox serum ferritin |
LIC transfusional hemosiderosis blood transfusions adults iron chelation 3-6 months after allogeneic hematopoietic stem cell transplantation |
Metabolic Diseases Deferasirox Hemosiderosis Iron Metabolism Disorders |
Iron Overload Metabolic disorder Iron |
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |