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Chronic Iron Overload clinical trials

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NCT ID: NCT06215287 Not yet recruiting - Clinical trials for Chronic Iron Overload

Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials

Start date: March 29, 2024
Phase:
Study type: Observational

The objective of this survey is to assess the knowledge of HCPs in relation to the recommended posology and biological monitoring for Exjade, based on the current locally valid Exjade educational materials (including the physician's reference checklist)

NCT ID: NCT05440487 Completed - Clinical trials for Chronic Iron Overload

Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload

EXCALIBUR
Start date: September 15, 2015
Phase:
Study type: Observational

This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods.

NCT ID: NCT02720536 Completed - Clinical trials for Chronic Iron Overload

Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

Start date: August 16, 2016
Phase: Phase 3
Study type: Interventional

Extend evaluation of deferasirox film-coated tablet (FCT) formulation

NCT ID: NCT01825512 Completed - Clinical trials for Chronic Iron Overload

Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

Start date: March 17, 2014
Phase: Phase 3
Study type: Interventional

Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40 mg/kg/day in paediatric patients (1 month < 18 years old) affected by hereditary haemoglobinopathies and requiring frequent transfusions and chelation.

NCT ID: NCT01740713 Completed - Clinical trials for Chronic Iron Overload

Pharmacokinetic Study of Deferiprone in Paediatric Patients

DEEP-1
Start date: December 2012
Phase: Phase 2
Study type: Interventional

Deferiprone (DFP) is the most extensively studied oral iron chelator to date. It has been authorised in Europe in 1999 for the treatment of iron overload in patients with beta-thalassaemia major when DFO is contraindicated or inadequate. Despite a wide experience of DFP there are limited experimental data available on DFP in children and no pharmacokinetic data in children under 6 years of age. On the basis of the existing data in adults and adolescent, in the DEEP-1 trial a pharmacokinetic bridging model will be developed to support the dose selection in children aged less than 6 years. The study will consist of two phases, namely an experimental phase, during which patients will receive a single dose and a modeling phase, during which PK data obtained after single dose in patients < 6 years of age will be analysed in conjunction with historical PK data in adults and older children and adolescents. The model-based analysis of the data obtained after single dose will enable the assessment of the dosing regimen required for the purpose of accurate pharmacokinetic bridging. The ratio between the predicted systemic exposure parameters (AUC and Cmax) in the target population and reference group will be used as basis for recommendation of the dose in the target population.