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Iron Overload clinical trials

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NCT ID: NCT01459718 Terminated - Clinical trials for Cardiac Iron Overload

Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload

Start date: January 2011
Phase: Phase 2
Study type: Interventional

The primary efficacy endpoint of this interventional study was to evaluate the number of patients achieving a complete response (CR), defined as patients switching from intensive deferasirox -DFO treatment, at any time point during the 24 months of study, to deferasirox monotherapy based on improvement in the cardiac magnetic resonance imaging (MRI) T2* value to >10ms, and continue to maintain their MRI T2* to values >10 msec.

NCT ID: NCT01363908 Terminated - Beta-Thalassemia Clinical Trials

Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload

Start date: August 10, 2011
Phase: Phase 2
Study type: Interventional

This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-<12, and 12-<18 years old. The study is designed to initially assess the pharmacokinetics and safety of SSP-004184AQ in older children (adolescents, 12-<18 years old) and then if deemed safe, in younger children (6-<12 years old).

NCT ID: NCT01342705 Terminated - Iron Overload Clinical Trials

Phlebotomy and Risk of Hepatocellular Carcinoma in Patients With Compensated Alcoholic Cirrhosis

CIRROX
Start date: May 2011
Phase: Phase 3
Study type: Interventional

The main objective of the study is to assess in patients with compensated alcoholic cirrhosis and hepatic iron overload (HIO), as assessed by MRI, the effect of phlebotomy in order to lower and maintain serum ferritin below 50 µg / l on the risk of hepatocellular carcinoma (HCC) occurrence. The effect of bloodletting will be jointly evaluated on 1) episodes of hepatic decompensation, 2) non HCC liver-related mortality 3) changes in HIO during follow-up.

NCT ID: NCT01326845 Terminated - Clinical trials for Myelodysplastic Syndrome

Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

MACS1574
Start date: December 2011
Phase: Phase 4
Study type: Interventional

The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

NCT ID: NCT01159067 Terminated - Clinical trials for Chronic Myelomonocytic Leukemia

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

Start date: July 2010
Phase: Phase 2
Study type: Interventional

RATIONALE: Low dose deferasirox may be safe and effective in treating patients who have undergone hematopoietic stem cell transplant and have iron overload. PURPOSE: This pilot clinical trial studies safety and tolerability of deferasirox in hematopoietic stem cell transplant recipients who have iron overload. Effect of low dose deferasirox on labile plasma iron is also examined.

NCT ID: NCT00658411 Terminated - Clinical trials for Acute Myeloid Leukemia

Deferoxamine for Iron Overload Before Allogeneic Stem Cell Transplantation

Start date: August 2008
Phase: N/A
Study type: Interventional

The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

NCT ID: NCT00602446 Terminated - Breast Cancer Clinical Trials

Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant

Start date: August 2007
Phase: Phase 2
Study type: Interventional

RATIONALE: Deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant. PURPOSE: This phase II trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.