The DEEP project has received research funding from the European Union under the 7th Framework Programme

DEEP-3 Performing a long-term safety study of deferiprone use in paediatric patients

The study – 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. Patients treated with deferiprone are followed up throughout their treatment, from its start up to conclusion in October 2015.

Objectives – DEEP-3 primary objective is to assess the incidence of serious adverse drug reactions related to deferiprone treatment in children aged 1 month – 18 years diagnosed with beta-thalassaemia major by conducting a multi-centre, multi-national, observational cohort study with both retrospective (using chart review) and prospective data collection. In addition, incidence of non-serious ADRs and risk factors for ADRs related to DFP treatment are also investigated.

A guideline including the safety data collected within DEEP-3 will be produced to improve prescribing of DFP in paediatric patients. Data collection was started in November 2012.

Centres involved – The DEEP-3 study currently involves 18 recruiting centres from 7 different countries: Albania (1), Cyprus (1), Greece (1), Egypt (1), Tunisia (1), Morocco (2), and Italy (11). The coordinating centre is the “Azienda Ospedaliera di Padova – AODP” (Padua, Italy). In order to train and encourage the local investigators and medical staff, extensive training was conducted in all the centres.

Study status – As of October 2015, 283 patients (86% of 328 subjects of the study population) were enrolled in the study and 222 completed the observation.

Moreover, the study received ethical approval for two new centres in Casablanca (Hôpital 20 août and Hôpital Universitaire d’enfants Abderrahim Harrouchi) and the Centre of Tunis started patients recruitment. Finally, two new centres in Egypt, University of Zagazig and University of Alexandria, are in the process of being included in DEEP-3.

Data collection – Anonymised patient data such as demographic data, transfusion regimen, chelation therapy, concomitant medications, diagnoses and laboratory data, are collected via an electronic case report form (e-CRF). Any adverse medical finding, which might be related to DFP therapy, is documented by the investigators and further assessed by the study team. It is anticipated that 328 patients will be recruited.