The DEEP project has received research funding from the European Union under the 7th Framework Programme
The study – The DEEP-2 study is a Phase III multicentre, randomised, open label, non-inferiority active-controlled trial aiming 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.
Objectives – The main goal of the study is to provide evidence-based measurement of DFP efficacy in comparison with DFX, in terms of changes of serum ferritin levels and cardiac iron overload in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation.
The DEEP-2 primary outcome is to evaluate the percentage of successfully chelated patients (Time Frame: 12 months), assessed by serum ferritin levels (in all patients) and cardiac MRI T2* (in patients above 10 years of age able to perform an MRI scan without sedation). Secondary objectives of the DEEP-2 trial are the evaluation of the treatment efficacy in terms of hepatic iron concentrations measured by liver MRI (in all patients able to perform MRI scan without sedation), the assessment of the safety and tolerability profiles of the treatment, the healthcare resources utilisation and patient global assessment, including compliance and quality of life (QoL) evaluation, to confirm the influence of demographic covariates on the pharmacokinetic disposition of treatment across a subset of the study population.
Centres Involved – The DEEP-2 study actually involves a total of 32 centres: Italy (12), Egypt (3), Greece (1), Albania (2), Cyprus (1), Tunisia (1), UK (3), Morocco (2), Lebanon (1), Turkey (5), Qatar (1).
Recruitment status – The trial will terminate when 310 patients will have completed the study. To this aim, at least 344 patients are expected to be enrolled.
The DEEP-2 efficacy/safety protocol has been approved by the competent Ethics Committees (ECs) for the three Egyptian centers (Alexandria, Cairo and Zagazig), the two Moroccan centres (both in Casablanca), the Tunisian center in Tunis, the Greek center in Athens, the three centres in UK (one in Romford and two in London), the twelve centres in Italy and by the national EC for both the Albanian centres (Lushnja and Tirana).