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Iron Overload clinical trials

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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: 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: NCT01395199 Completed - Thalassemia Clinical Trials

Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major

AmloThal
Start date: August 2012
Phase: Phase 3
Study type: Interventional

This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2* by MRI initially, at 6 and 12 months.

NCT ID: NCT01376622 Completed - Iron Overload Clinical Trials

Changes in Pituitary Iron and Volume With Deferasirox

Start date: November 2008
Phase:
Study type: Observational

Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.

NCT ID: NCT01369719 Completed - Thalassemia Clinical Trials

Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Start date: February 2010
Phase: N/A
Study type: Interventional

Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

NCT ID: NCT01335035 Completed - Iron Overload Clinical Trials

Open-Label Single-Arm Pilot Study in Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients With Transfusional Iron Overload

Start date: December 2008
Phase: Phase 4
Study type: Interventional

This study has been designed to establish the efficacy and safety of deferasirox in patients with iron overload from 6 to 18 months after allogeneic hematopoietic stem cell transplant (HSCT). The purpose of this study is to assess the mean change in serum ferritin after 52 weeks of treatment with deferasirox, in patients with iron overload (defined with serum ferritin levels ≥ 1000 ng/ml and receiving > 20 RBC concentrates) after allogeneic HSCT.

NCT ID: NCT01273766 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies

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

RATIONALE: Deferasirox may remove excess iron from the body caused by blood transfusions. PURPOSE: This clinical trial studies deferasirox in treating iron overload caused by blood transfusions in patients with hematologic malignancies.

NCT ID: NCT01254227 Completed - Clinical trials for Cardiac Iron Overload

Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload

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

This study will evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to chronic blood transfusions.