Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis
NCT00395629 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2011-05-30
Summary
Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.
Conditions
- Iron Overload
- Hereditary Hemochromatosis
Interventions
- DRUG
-
Deferasirox (ICL670)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals, M.D. · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-08-31
- Primary Completion
- 2007-12-31
- Completion
- 2009-03-31
Countries
- United States
- Australia
- Canada
- France
- Germany
- Italy
Study Locations
More Related Trials
-
Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients
NCT00110617 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
NCT00564941 ·Status: COMPLETED ·Phase: PHASE4
-
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
NCT00171210 ·Status: COMPLETED ·Phase: PHASE3
-
Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions
NCT00061750 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
NCT00110266 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias
NCT00061763 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
NCT01090323 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)
NCT03203850 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload
NCT01459718 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of Deferasirox in Non-transfusion Dependent Thalassemia Patients With Iron Overload and a One Year Open-label Extension Study
NCT00873041 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)
NCT00171301 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
NCT01709838 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
NCT01254227 ·Status: COMPLETED ·Phase: PHASE2
-
Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients
NCT00350662 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Subcutaneous Desferrioxamine as Treatment for Transfusional Hemochromatosis
NCT00000595 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
NCT00560820 ·Status: COMPLETED ·Phase: PHASE1
-
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
NCT00117507 ·Status: COMPLETED ·Phase: PHASE4
-
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload
NCT00379483 ·Status: COMPLETED ·Phase: PHASE2
-
Early and Low Dose Deferasirox (3.5 mg/kg FCT) to Suppress NTBI and LPI as Early Intervention to Prevent Tissue Iron Overload in Lower Risk MDS
NCT03920657 ·Status: TERMINATED ·Phase: PHASE2
-
Treatment of Iron Overload With Deferasirox (Exjade) in Hereditary Hemochromatosis and Myelodysplastic Syndrome
NCT01892644 ·Status: WITHDRAWN ·Phase: PHASE2
-
Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)
NCT02125877 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis
NCT00171171 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Importance of Treating Iron Overload in Sickle Cell Disease
NCT00981370 ·Status: TERMINATED ·Phase: PHASE3
-
Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients
NCT00349453 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia
NCT01709032 ·Status: COMPLETED ·Phase: PHASE1/PHASE2