Overview

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

Status:
Completed
Trial end date:
2017-09-21
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Consorzio per Valutazioni Biologiche e Farmacologiche
Collaborator:
European Commission
Treatments:
Deferasirox
Deferiprone