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Iron Overload clinical trials

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NCT ID: NCT01671111 Terminated - Clinical trials for Iron Overload Due to Repeated Red Blood Cell Transfusions

Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)

Start date: August 14, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload

NCT ID: NCT01631708 Completed - Clinical trials for Hereditary Haemochromatosis

Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

Mi-iron
Start date: June 2012
Phase: N/A
Study type: Interventional

Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to maintain normal iron levels. It is unclear, however, whether treatment is necessary when individuals have moderate elevation of iron in the body. This research project will study the effects of treatment in this group by assessing a number of scans, questionnaires and blood tests in treated and untreated individuals.

NCT ID: NCT01610297 Completed - Clinical trials for Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major

Post Hematopoietic Stem Cell Transplantation

Start date: September 2013
Phase: Phase 4
Study type: Interventional

This is a prospective, single-arm, multicenter, national, phase II clinical study. The purpose of this Phase II study is to examine the safety and efficacy of deferasirox to decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia major.

NCT ID: NCT01604941 Terminated - Clinical trials for Iron Overload Due to Repeated Red Blood Cell Transfusions

Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy

Start date: September 14, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron overload whose primary diagnosis is hereditary or congenital anemia. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload.

NCT ID: NCT01572922 Completed - Iron Overload Clinical Trials

Massive Iron Deposit Assessment

Start date: June 11, 2012
Phase: N/A
Study type: Interventional

Iron overload is a severe complication of multiple blood transfusions. As the body has no physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to quantify excessive iron accumulation and to monitor response to iron chelation therapy. Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC ~ 15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2* is so high that the MR signal decays before it can be measured accurately. Overall accrual: 200 patients Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of people with large amounts of iron and compare the results with the same patient's liver bx. Estimated patient accrual is 150. It is estimated that 41 of these patients will have clinical indication for liver biopsy.

NCT ID: NCT01572818 Completed - Insulin Resistance Clinical Trials

Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

SAINPOS
Start date: October 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.

NCT ID: NCT01546415 Completed - Iron Overload Clinical Trials

Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia

Start date: October 2011
Phase: Phase 4
Study type: Interventional

The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.

NCT ID: NCT01541813 Terminated - Clinical trials for Rare Iron Overloads Except C282Y Homozygosity

Rare Iron Overloads Except C282Y Homozygosity : Description and Characterization.

HEPCIDEF
Start date: March 2011
Phase: N/A
Study type: Observational

Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

NCT ID: NCT01516853 Completed - Iron Overload Clinical Trials

Non-invasive Quantification of Liver Iron With MRI

Start date: January 2012
Phase:
Study type: Observational

The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic, specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.

NCT ID: NCT01511848 Not yet recruiting - Sickle Cell Disease Clinical Trials

Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload

Start date: February 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload Primary Outcome Measures: • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator. Secondary Outcome Measures: • The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.