We are glad to announce that the DEEP-2 study Phase III multicentre, randomised, open label, non-inferiority active-controlled trial aimed at comparing for the first time the efficacy of deferiprone (DFP) versus deferasirox (DFX) in paediatric patients aged from 1 month to less than 18 years, affected by hereditary haemoglobinopathies has terminated and the results are available on EudraCT Database and on the DEEP website. Included in the DEEP (DEferiprone Evaluation in Paediatrics) project (FP7 GA n. 261483), DEEP-2 trial involved 393 patients recruited in 23 clinical centres in 7 EU and non-EU countries: Albania (2), Cyprus (1), Greece (1), Egypt (3), Italy (12), Tunisia (1), UK (3).
In particular, the study intended to investigate the changes in terms of ferritin levels and cardiac iron concentration in order to assess the non-inferiority of deferiprone compared to deferasirox in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation. Overall, the study provided evidence to support the use of DFP in paediatric patients.
DEEP is a 6-year European Project (FP7) coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche and involving 23 recruiting centres in European and non-European Countries. DEEP Project has been developed with the specific intent to integrate the existing information on deferiprone use in paediatric patients and evaluate its safety in this particular population.
For more information about DEEP project, visit the official web page.