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Iron Overload clinical trials

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NCT ID: NCT00171821 Completed - Clinical trials for Transfusion-dependent Iron Overload

A Study Assessing the Efficacy and Safety of Deferasirox in Patients With Transfusion-dependent Iron Overload

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This study uses a single arm, multi-center, open-label trial design. The study will assess the efficacy and safety of 52 weeks of treatment with deferasirox (ICL670) in patients with evidence of transfusion induced iron overload.

NCT ID: NCT00171301 Completed - Iron Overload Clinical Trials

Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)

ESCALATOR
Start date: June 2005
Phase: Phase 4
Study type: Interventional

To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters.

NCT ID: NCT00171210 Completed - Clinical trials for Transfusional Iron Overload in ß-thalassemia

An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

Start date: October 2004
Phase: Phase 3
Study type: Interventional

A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years. The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

NCT ID: NCT00138684 Completed - Insulin Resistance Clinical Trials

Cytochrome P450 2E1 and Iron Overload

Start date: September 2003
Phase: Phase 2
Study type: Interventional

The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

NCT ID: NCT00117507 Completed - Clinical trials for Myelodysplastic Syndromes

Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Start date: September 2005
Phase: Phase 4
Study type: Interventional

Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox. Deferasirox were administered orally once per day for 12 months.

NCT ID: NCT00110617 Completed - Sickle Cell Disease Clinical Trials

Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients

Start date: May 2005
Phase: Phase 2
Study type: Interventional

This study will examine the long-term safety and efficacy of Deferasirox in patients with sickle cell disease and iron overload from repeated blood transfusions.

NCT ID: NCT00110266 Completed - Clinical trials for Myelodysplastic Syndrome

Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Start date: July 25, 2005
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

NCT ID: NCT00069862 Completed - Beta-Thalassemia Clinical Trials

Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

Start date: September 2003
Phase: Phase 1/Phase 2
Study type: Interventional

A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.

NCT ID: NCT00067080 Completed - Anemia, Sickle Cell Clinical Trials

Safety of ICL670 vs. Deferoxamine in Sickle Cell Disease Patients With Iron Overload Due to Blood Transfusions

Start date: May 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the new orally active iron chelator, ICL670, is as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.

NCT ID: NCT00061763 Completed - Clinical trials for Myelodysplastic Syndromes

Study of Deferasirox in Iron Overload From Beta-thalassemia Unable to be Treated With Deferoxamine or Chronic Anemias

Start date: May 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of the oral iron chelator Deferasirox on liver iron content after one year of treatment in patients with iron overload from repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver iron content will be measured by liver biopsy at the beginning of the study and after one year of treatment. However, those patients living in the San Francisco/Oakland area may have a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The SQUID is a non-invasive magnetic means to measure liver iron content.