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Hemochromatosis clinical trials

View clinical trials related to Hemochromatosis.

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NCT ID: NCT01398644 Unknown status - Clinical trials for Hereditary Hemochromatosis

Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

Start date: May 2008
Phase: Phase 3
Study type: Interventional

Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.

NCT ID: NCT00981370 Recruiting - Anemia, Sickle Cell Clinical Trials

Clinical Importance of Treating Iron Overload in Sickle Cell Disease

Start date: April 2009
Phase: Phase 3
Study type: Interventional

Hypothesis: The investigators suspect that significant degrees of iron overload in subjects with SCD result in decreased red cell survival, abnormal endothelial function and markedly dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude of these effects is proportional not only to the magnitude of total body iron stores but also to the duration of exposure to the high iron levels in tissues. Primary objective To determine if red cell survival as assessed by 51Cr red cell survival analysis, hemoglobin level, reticulocyte count, lactic acid dehydrogenase, and plasma hemoglobin in sickle cell patients is related to the degree of iron overload. Secondary objective(s) 1. Determine if the magnitude of endothelial-dependant vasodilation is related to The degree of iron overload. 2. Determine if the degree of change in cardiac beat to beat variability in response to hypoxic exposure or to cold exposure ("cold-face-test") is related the magnitude of iron overload. The primary measure of iron overload will be MRI determination of liver iron concentration.

NCT ID: NCT00749515 Completed - Sickle Cell Disease Clinical Trials

Pilot Study for Patients With Poor Response to Deferasirox

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

This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload. The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.

NCT ID: NCT00712738 Completed - Thalassemia Clinical Trials

Oral Nifedipine to Treat Iron Overload

Start date: June 20, 2008
Phase: Phase 1
Study type: Interventional

This study will determine if nifedipine, a medication used to treat high blood pressure, can help treat iron overload, a condition in which the body contains too much iron. Iron overload can be caused by the body's inability to regulate iron or by medical treatments, such as multiple blood transfusions. Over time, it can cause problems with the liver, heart and glands. Treatments include reducing iron intake in the diet or removing the excess iron using medical therapies. Recently, nifedipine was found to cause iron loss in the urine of small animals. This study will see if the drug can increase the removal of iron into the urine in humans as well. People 18 years of age and older with iron overload may be eligible for this study to undergo the following procedures: Study Day 1 Participants come to the NIH Clinical Center for a medical history, physical examination, blood and urine tests, electrocardiogram (EKG) and echocardiogram (heart ultrasound). Study Day 2 Participants will collect three urine samples: one is collected over 4 hours, followed by a second over 4 hours. Both of these samples are collected at NIH in the outpatient day hospital. At home, a third urine sample will be collected over 16 hours. For 1 week before the collections, participants are asked not to drink tea or eat foods high in Vitamin C or iron. They are also asked not to take any iron chelating medications. Study Day 3 Participants repeat the same urine collections as on day 2. They collect a 4-hour urine sample at the outpatient day hospital at NIH. They will then take a 20-mg tablet of nifedipine, and remain in the clinic 4 hours for blood pressure monitoring. A second urine sample during this time. They then return home to collect the final 16-hour sample, which they bring to the clinic the following day. Again, they are instructed to avoid a diet high in vitamin C, iron rich foods, tea, and to avoid taking any iron chelating medications.

NCT ID: NCT00587535 Completed - Hemochromatosis Clinical Trials

Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration

Start date: August 2003
Phase: N/A
Study type: Observational

The purpose of this study is to determine if a new MR pulse sequence is accurate in determining how much iron is in the liver.

NCT ID: NCT00509652 Recruiting - Hemochromatosis Clinical Trials

Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis

Start date: January 2006
Phase: N/A
Study type: Interventional

Primary hemochromatosis is the most frequent hereditary condition in Scandinavia. The condition may result in serious organ damage which can be prevented by therapy, but only few patients develop such organ damage. The optimal treatment, therefore, is still a matter of discussion Prevention of organ damage has traditionally been accomplished by drawing of full blood (phlebotomy), which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment. The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective removal of red blood cells (red cell apheresis). Possible drawbacks of this technique may be higher costs, prolonged time for each therapeutic procedure, and certain requirements to the patients. The possible advantages are the reduced number of therapeutic procedures and less strain for the patient. No larger, randomized study has been published in order to determine which method should be preferred. This study is a controlled trial in which participating patients are asked to be randomized to red cell apheresis or traditional phlebotomy. Each group will be followed by means of well-defined assessments in order to explore possible advantages and disadvantages of each method in order to establish what type of treatment should be recommended.

NCT ID: NCT00440986 Completed - Clinical trials for Hereditary Hemochromatosis

Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis

Start date: April 2003
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH

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: NCT00350662 Completed - Hemochromatosis Clinical Trials

Study With Deferiprone and/or Desferrioxamine in Iron Overloaded Patients

Start date: January 2002
Phase: Phase 3
Study type: Interventional

Comparison of efficacy and toxicity of the combination treatment of deferiprone and desferrioxamine with the single agent treatment of either drug

NCT ID: NCT00349453 Completed - Hemochromatosis Clinical Trials

Study Using Deferiprone Alone or in Combination With Desferrioxamine in Iron Overloaded Transfusion-dependent Patients

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

Systematical (retro- and prospective) investigation of the long-term safety (toxicity assessment according to CTCAE v3.0) and efficacy of deferiprone either given alone or in combination with desferrioxamine