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Beta-Thalassemia clinical trials

View clinical trials related to Beta-Thalassemia.

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NCT ID: NCT03637556 Completed - Thalassemia Major Clinical Trials

Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation

Start date: August 20, 2019
Phase: Phase 2
Study type: Interventional

This study is a multicenter, open-label, two-period crossover design that evaluates the safety, tolerability, pharmacokinetics and preliminary evidence of iron chelating activity of DST-0509 as compared to Jadenu and Exjade in transfusion-dependent thalassemia patients with transfusional iron overload, requiring iron chelation therapy and demonstrating an inadequate response to Jadenu or Exjade for greater than 3 months duration. Up to 36 patients will be evaluated (18 in each treatment arm), however, the balanced randomization may enroll fewer patients based on recruitment status.

NCT ID: NCT03591900 Completed - Diabetes Clinical Trials

The Use of CGMS to Detect Alterations of Blood Glucose in Thalassemic Patients

Start date: April 2014
Phase: N/A
Study type: Interventional

The aim of the study is to: - Assess the pattern of glucose homeostasis in patients with B thalassemia . - To detect early impairment in glucose metabolism and prediabetic state in B thalassemia patients using continuous glucose monitoring system. - To study the prevalence and type of DM in B thalassemia patients. - A comparative study of standard insulin therapy compared to insulin pump therapy in thalassemic diabetic patients will be done. The study will include screening of 200 children and adolescents who are regularly attending the Hematology Oncology Clinic and fulfilling the inclusion criteria for abnormalities of glucose homeostasis. A pilot study will be done on 15 patients with abnormal glucose tolerance which will include: A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration . B-Therapeutic intervention: Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to • Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy.

NCT ID: NCT03591575 Completed - Iron Overload Clinical Trials

Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children

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Start date: November 9, 2018
Phase: Phase 4
Study type: Interventional

This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on iron chelation therapy. Half the patients in the study will receive deferiprone, and the other half will receive placebo, for up to 12 months.

NCT ID: NCT03462784 Not yet recruiting - Beta-thalassemia Clinical Trials

Complications in Children With B- Thalassemia Major

Start date: August 1, 2020
Phase:
Study type: Observational

Worldwide, there are more than 60,000 births annually of serious forms of thalassemia .The World Health Organization considers thalassemia to be a major health burden. Beta- thalassemia is a group of recessively inherited disorders of hemoglobin synthesis characterized by reduced synthesis of the ß-globin chain caused by a mutation. The homozygous state results in severe anemia which needs regular blood transfusion.

NCT ID: NCT03432364 Completed - Clinical trials for Transfusion Dependent Beta-thalassemia

A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT)

Start date: March 29, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-arm, multi-site, single-dose, Phase 1/2 study to assess ST-400 in 6 subjects with transfusion-dependent β-thalassemia (TDT) who are ≥18 and ≤40 years of age. ST-400 is a type of investigational therapy that consists of gene edited cells. ST-400 is composed of the patient's own blood stem cells which are genetically modified in the laboratory using Sangamo's zinc finger nuclease (ZFN) technology to disrupt a precise and specific sequence of the enhancer of the BCL11A gene (which normally suppresses fetal hemoglobin production in erythrocytes). This process is intended to boost fetal hemoglobin (HbF), which can substitute for reduced or absent adult (defective) hemoglobin. ST-400 is then infused back into the patient after receiving conditioning chemotherapy to make room for the new cells in the bone marrow, with the aim of producing new erythrocytes with increased amounts of HbF. The primary objective is to understand safety and tolerability of ST-400, and secondary objectives are to assess the effects on HbF levels and transfusion requirements.

NCT ID: NCT03402191 Recruiting - Thalassemia Clinical Trials

L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

Start date: July 2016
Phase: Phase 4
Study type: Interventional

This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

NCT ID: NCT03381833 Terminated - Beta-Thalassemia Clinical Trials

A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia

Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

This study is a Phase 2 multicenter, randomized, open-label, parallel-group study. The primary objective of the study is to evaluate the effect of LJPC-401 (synthetic human hepcidin) on iron levels in patients with transfusion-dependent beta thalassemia with myocardial iron overload.

NCT ID: NCT03358498 Not yet recruiting - ß-thalassemia Clinical Trials

Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox

Start date: December 1, 2017
Phase: N/A
Study type: Observational

Regular blood transfusions are essential for the management of haematological conditions such as β-thalassemia major. As a result, however, patients with these conditions are susceptible to the development of transfusion-dependent iron overload (hemosiderosis or secondary iron overload

NCT ID: NCT03351829 Not yet recruiting - Beta-Thalassemia Clinical Trials

Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

This is a Phase I/II clinical trial of gene transfer for treating Beta-thalassemia using a self-inactivating lentiviral vector to functionally correct the defective gene(s). The objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

NCT ID: NCT03311243 Completed - Clinical trials for Chronic Periodontitis

Periodontal Therapy in Thalassemia Major Patients

Start date: January 11, 2016
Phase: N/A
Study type: Interventional

The study aims to evaluate the effect of local non surgical periodontal therapy on the systemic pro-inflammatory markers in the β-thalassemia (TM-β) patients with chronic periodontitis and systemically healthy demographically matched controls with chronic periodontitis. Both groups will receive non surgical periodontal therapy.