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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT01740713
Study type Interventional
Source Consorzio per Valutazioni Biologiche e Farmacologiche
Contact
Status Completed
Phase Phase 2
Start date December 2012
Completion date February 2014

See also
  Status Clinical Trial Phase
Completed NCT05440487 - Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
Completed NCT01825512 - Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients Phase 3
Completed NCT06215287 - Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
Completed NCT02720536 - Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation Phase 3