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Hemoglobinopathies clinical trials

View clinical trials related to Hemoglobinopathies.

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NCT ID: NCT00920972 Recruiting - Hemoglobinopathies Clinical Trials

Campath/Fludarabine/Melphalan Transplant Conditioning for Non-Malignant Diseases

Start date: December 2001
Phase: Phase 1/Phase 2
Study type: Interventional

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

NCT ID: NCT00887081 Recruiting - Hemoglobinopathies Clinical Trials

Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies

IFNRIBAHE
Start date: January 2009
Phase: Phase 4
Study type: Interventional

Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. This study is carried ahead to assess the impact of combination therapy with pegylated-interferon and ribavirin in a large cohort of italian patients with beta thalassemia major - transfused and not transfused, sickle cell disease and sickle/beta-thalassemia.

NCT ID: NCT00777231 Completed - Sickle Cell Disease Clinical Trials

Phase I/II Pilot Study of Mixed Chimerism to Treat Hemoglobinopathies

Start date: January 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this research study is to establish chimerism and avoid graft-versus-host disease in patients with Hemoglobinopathies to halt disease progression.

NCT ID: NCT00744692 Completed - Thalassemia Clinical Trials

Reduced Intensity Conditioning for Umbilical Cord Blood Transplant in Pediatric Patients With Non-Malignant Disorders

Start date: October 2008
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor chimerism at 180 days) following reduced intensity conditioning (RIC) regimens in pediatric patients < 21 years receiving cord blood transplantation for non-malignant disorders.

NCT ID: NCT00673608 Completed - Clinical trials for Myelodysplastic Syndromes

Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

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

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients

NCT ID: NCT00669305 Completed - Sickle Cell Anemia Clinical Trials

Bone Marrow for Hemoglobinopathy Research

Start date: May 15, 2008
Phase:
Study type: Observational

Human participants affected with sickle cell disease or thalassemia will donate bone marrow for use in experimental laboratory models to study potential new treatments. This is an observational study using bone marrow from human participants. The investigators will use sickle cell and thalassemia mouse models to observe and evaluate the possibility of correcting these disorders through genetic alterations or drug treatment.

NCT ID: NCT00578344 Terminated - Sickle Cell Disease Clinical Trials

Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP

SCALLOP
Start date: July 2005
Phase: N/A
Study type: Interventional

Patients are being asked to participate in this study because they have severe sickle cell anemia (SCD) with or without the beta thalassemia trait. Sickle cell anemia is an illness where the red blood cells change shape and can clog up blood vessels. This keeps the body from getting the oxygen it needs. Thalassemia is when the body does not make enough hemoglobin, something that helps the oxygen get to the places it needs to go in the body. The patient may or may not need to get regular blood transfusions (getting more blood) to improve their quality of life (feel better) and prevent organ damage (problems with the brain, heart, lung, kidney, and gonad, for example.). The transfusions can also cause problems, including iron overload (too much iron in the blood), which can be fatal (patients can die) without regular deferoxamine shots. Even with the best usual treatments, people with thalassemia or SCD die sooner. There is no proven cure. We would like to treat patients using bone marrow transplantation, a treatment that has been used for people with SCD. The transplant uses healthy "matched" bone marrow. This comes from a brother or sister who does not have sickle cell disease or severe thalassemia. If the treatment works, the sickle cell disease or thalassemia may be cured. This treatment has been used to treat patients with sickle cell disease or thalassemia. It has worked in most cases. We hope, but cannot promise, that the transplanted marrow will make healthy cells, and patients will not have sickle cell disease or severe thalassemia anymore. We do not know what effect this treatment will have on the damage that has already been done by the disease. Finding that out is the main reason for this study. Currently, very little has been reported about organ function after bone marrow transplants in patients with sickle cell anemia.

NCT ID: NCT00481260 Completed - Clinical trials for Hgb C Hemoglobinopathy

Characteristics of Hgb C Carriers in Northern Israel and Clinical Features Among Hgb Homozygous

Start date: May 2007
Phase: N/A
Study type: Observational

Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are diagnosed as homozygous to this disease is quite benign but not study in large groups. Also the characteristics of carriers and the incidence in northern Israel were a large arab population lives, was not study. The results of this study can be useful for screening purpose in a area were another hemoglobinopathies are frequent.

NCT ID: NCT00456443 Completed - Sickle Cell Anemia Clinical Trials

Invasive Infections in Children With Hemoglobinopathies

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

Patients diagnosed as having hemoglobinopathies are exposed to serious bacterial infections, principally those patients that underwent splenectomy. Since the introduction of anti pneumococcal vaccine the incidence decreased significantly but other bacteria besides encapsulated bacteria takes place as principal cause of invasive infections. The purpose of this study is to analyse in a retrospective study the incidence of those infections in a group of patients suffering from thalassemia and sickle cell anemia treated in our clinic.

NCT ID: NCT00427661 Recruiting - Sickle Cell Disease Clinical Trials

A Pilot Study of HSCT for Patients With High-Risk Hemoglobinopathy Using a Nonmyeloablative Preparative Regimen

Start date: June 2002
Phase: N/A
Study type: Interventional

Hypothesis 1: A novel nonmyeloablative condition regimen will be safe and efficacious in producing stable donor chimerism and cure of severe hemoglobinopathy. Hypothesis 2: Stable donor chimerism will result in amelioration of cerebral vasculopathy, improved cerebral perfusion and neurocognitive function. Specific Aim 1: Study the safety and efficacy of a novel non-toxic conditioning regimen for HSCT for patients with severe hemoglobinopathies and the kinetics of lineage specific chimerism after HSCT We will test our hypothesis that a novel nonmyeloablative condition regimen will be safe and efficacious in producing stable donor chimerism and cure of severe hemoglobinopathy: Specific Aim 2: Optimize the immunosuppressive regimen for HSCT patients through a thorough understanding of the pharmacokinetics of Busulfan (BU) and mycophenolate mofetil (MMF) in the patient population. This will involve: 1. Determine the pharmacokinetics of intravenously and orally administered MMF and intravenous BU in patients receiving HSCT. 2. Determine the relationship of Area under the curve (AUC) of BU and mean trough concentrations of mycophenolic acid (MPA) to engraftment and graft versus host disease (GVHD). 3. Determine the relationship of Area under the curve (AUC) and steady state concentration of BU to engraftment at day 30 and 1 year post HSCT. Specific Aim 3: Study the effect of complete or partial donor chimerism on silent and overt cerebral vasculopathy, and neurocognitive functioning in patients with SCD undergoing HSCT. We will test our hypothesis that stable donor chimerism will result in improvement in cerebral vasculopathy and neurocognitive function. This will include. 1. Determine effect of transplantation silent and overt cerebral vasculopathy by comparison MRA and TCD 1 year after HSCT to pre-HSCT studies. 2. Determine effect on HSCT on neurocognitive function. Specific Aim 4: To determine the rate of T cell immune reconstitution in children with sickle cell disease following myeloablative compared to nonmyeloablative stem cell transplantation, using immunophenotyping assays, CDR3 spectratyping TREC analysis, and measurement of T cell specific donor engraftment.