DEEP-3 is a long-term observational safety study which evaluates the nature and incidence of adverse effects of deferiprone (DFP) in children and adolescents with beta-thalassaemia major and currently involves 18 recruiting centres from 7 different countries: Albania, Cyprus, Greece, Egypt, Italia, Morocco and Tunisia.
On October 2015, 283 patients (86% of 328 subjects of the study population) were enrolled, 36 of which are currently in the prospective phase of the study. The observation, which aims to investigate serious and non-serious adverse reactions, as well as risk factors for ADRs related to deferiprone treatment, has ended for 166 patients. The mean observation time per patient was currently 2.1 years, with 595 person-years (84% of 711 person-years).
To date, the study is in the last collection episode for most of the centres involved (Tirana, Nicosia, Bari, Naples, Padua, Palermo and Florence) that will be closed for recruitment soon. The prospective arm of the study will be concluded in October 2015, while retrospective data will be collected until termination of the study with reference to the same period (up to October 2015).
Recently the study successfully received the ethical approval for two new centres in Casablanca (Hôpital 20 août and Hôpital Universitaire d’enfants Abderrahim Harrouchi) and the recruitment started at Centre National de Greffe de Moelle Osseuse (CNGMO) of Tunis.
Furthermore, the DEEP-3 Study Team is currently in the process of including two new centres in Egypt: Alexandria and Zagazig.