The results of the DEEP-2 paediatric clinical trial are now available on ClinicalTrials.org as well as on the EU Clinical Trials Register.
DEEP-2 is a multi-centre, randomised, open-label, non-inferiority active-controlled efficacy-safety trial involving paediatric patients from 1 month to less than 18 years affected by transfusion-dependent haemoglobinopathies (DEEP-2; EudraCT 2012–000353-31; NCT01825512) performed according to a Paediatric Investigation Plan (PIP) agreed by PDCO (P/0357/2016).
The study was part of the EU funded project “DEferiprone Evaluation in Paediatrics” (DEEP, FP7 HEALTH-F4-2010-261483) coordinated by CVBF, also acting as a Sponsor of the study. The DEEP-2 Trial Leader, and CVBF CEO, Donato Bonifazi said that “The study showed that deferiprone was effective and safe in inducing control of iron overload during 12 months of treatment in paediatric patients with transfusion-dependent haemoglobinopathies. Considering the need for availability of more chelation treatments in paediatric populations, deferiprone offers a valuable treatment option for this age group.”
Related posts:
DEEP – “Towards new frontiers of paediatric clinical research”
QuBo, the multicenter observational transversal study for patients involved in the DEEP-2 trial
Drug safety of oral iron chelator deferiprone in children: a dissertation on the results of DEEP-3 Study
DEEP-2 study: the final results are available on EudraCT