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Iron Overload clinical trials

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NCT ID: NCT00481143 Completed - Clinical trials for Myelodysplastic Syndromes

Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload

Start date: May 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effects of iron chelation using deferasirox in low and INT-1 risk (referring to the international prognostic scoring system, IPSS) MDS patients who show signs of iron overload due to repeated blood transfusions. This trial is not recruiting patients in the United States.

NCT ID: NCT00452660 Completed - Clinical trials for Myelodysplastic Syndrome

Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load

Start date: May 2007
Phase: Phase 4
Study type: Interventional

Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.

NCT ID: NCT00447694 Completed - Iron Overload Clinical Trials

Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.

NCT ID: NCT00401336 Completed - Hepatitis C Clinical Trials

Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging

SURFER
Start date: November 2006
Phase: N/A
Study type: Interventional

Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. Because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. The aim of the study is to use a simplified magnetic resonance imaging (MRI) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

NCT ID: NCT00395629 Completed - Iron Overload Clinical Trials

Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

Start date: August 2006
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT00390858 Completed - Clinical trials for Transfusional Iron Overload

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.

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

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.

NCT ID: NCT00379483 Completed - Clinical trials for Transfusional Iron Overload

Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Start date: July 2002
Phase: Phase 2
Study type: Interventional

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

NCT ID: NCT00235391 Completed - Sickle Cell Disease Clinical Trials

Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload

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

This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

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.