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Beta-Thalassemia clinical trials

View clinical trials related to Beta-Thalassemia.

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NCT ID: NCT04526405 Completed - Covid19 Clinical Trials

Frequency of COVID-19 Antibodies in Patients With Hereditary Hematological Diseases

ThalaCoV
Start date: July 14, 2020
Phase:
Study type: Observational

In Italy there are about 5000 patients with dependent transfusion thalassemia (source Italian Thalassemia and Hemoglobinopathies - SITE) and a smaller number, currently not definable, of patients with sickle cell anemia in chronic transfusion. A recent study in the Lombardy region identified the positivity of anti-Covid-19 antibodies in 4.5-7% of asymptomatic donors (Valenti L et al). As already known, a preliminary study conducted in Italy (Motta I et al, Hussain FA et al, Taher A et al) reported only 11 cases of symptomatic infection all with benign evolution. Currently there are 15 reported cases (12 thalassemias and 3 sickle cell anemias). 75% of the cases have been identified in Lombardy. Our hypothesis is that in a percentage of polytransfused patients a transmission of the virus may have developed that stimulated the production of protective antibodies. This could be an explanation of the low contagiousness and severity of the infection in polytransfused patients. Currently no data are available for this purpose. This study will be conducted in collaboration with the Microbiology Unit and involves the determination of SARS-CoV-2 antibodies (anti-s1 and s2) by CLIA method with a high sensitivity (94.7%) and specificity (98.5%).

NCT ID: NCT04367701 Completed - Hemolysis Clinical Trials

Congenital Heart Surgery in Pediatric Patients With Beta-Thalassemia Major

Start date: January 15, 2012
Phase:
Study type: Observational

Authors compared incidence of Hemolysis on Cardiopulmonary Bypass surgery for repair of congenital heart disease in Pediatric Patients between patients with thalassemia major and control group

NCT ID: NCT04364269 Completed - Beta-Thalassemia Clinical Trials

Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia

VITHAL
Start date: June 11, 2020
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).

NCT ID: NCT04292314 Completed - Oxidative Stress Clinical Trials

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Start date: November 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the present study is evaluating the strength of combination therapy of hydroxy urea, omega 3, nigella sativa and honey on antioxidant-oxidant status (OXIDATIVE STRESS) in response to reactive oxygen species production (LIPID PEROXIDATION) and their effect on iron intoxication (IRON CHELATION) in pediatric major thalassemia.

NCT ID: NCT04260516 Completed - Thalassemia Major Clinical Trials

The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Start date: June 3, 2019
Phase: Phase 1
Study type: Interventional

The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration

NCT ID: NCT04211480 Completed - ß Thalassemia Major Clinical Trials

Safety and Efficacy Evaluation of γ-globin Reactivated Autologous Hematopoietic Stem Cells

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

This is a non-randomized, open label, single-dose, phase 1/2 study in up to 12 participants with β-thalassemia major.This study aims to evaluate the safety and efficacy of the treatment with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia major.

NCT ID: NCT04092205 Completed - Clinical trials for Beta Thalassemia Major

Phase 2a Pilot Study of NBMI Treatment in Patients With Beta Thalassemia Major, Requiring Iron Chelation

EMERA007
Start date: November 21, 2019
Phase: Phase 2
Study type: Interventional

A pilot study to explore safety and efficacy of NBMI treatment in patients with Beta Thalassemia Major requiring iron chelation Investigational product: NBMI (N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide Indication: Beta Thalassemia Major

NCT ID: NCT04067258 Completed - Beta-Thalassemia Clinical Trials

Choroidal Thickness in Beta-thalassemia Patients

Start date: May 1, 2019
Phase:
Study type: Observational

The purpose of this study is to examine choroidal thickness in beta-thalassemia patients and compare it to the one of healthy controls. An equal number of transfusion dependent beta-thalassemic patients and age and sex matched healthy volunteers will undergo spectral-domain optical coherence tomography utilizing the enhanced depth imaging application to visualize and measure the choroid.

NCT ID: NCT04054921 Completed - ß-thalassemia Clinical Trials

Safety Study for Beta Thalassemia Subjects on PTG-300

TRANSCEND
Start date: May 10, 2019
Phase: Phase 2
Study type: Interventional

In this study will investigate long term safety and use of the PTG-300 in Beta Thalassemia patients.

NCT ID: NCT03992001 Completed - Thalassemia Major Clinical Trials

Impact of the Preparation Method of Red Cell Concentrates on Transfusion Indices in Thalassemic Patients

Start date: May 14, 2018
Phase: Phase 4
Study type: Interventional

This study compares the effects of Packed Red Blood Cells (PRBCs) prepared in two different ways on the transfusion indices in beta(ß)-Thalassemia transfusion-dependent patients. The two blood components types derive from the whole blood. In one case, the whole blood is leukoreduced with subsequent plasma removal. In the other case, plasma, buffy coat, and red blood cells (RBCs) are first separated and subsequently, the RBCs leukoreduced. Each type of blood components will be subsequently given to one-half of the patients for a 6-month period and to the other half for other 6-month at the randomization phase, for a total of 12 months of crossed-treatment per patient.