Another step forward has been made toward the enrollment of new patients in the DEEP-2 study, the phase III multicentre, randomised, open label, non-inferiority active-controlled trial aiming at comparing for the first time the efficacy of deferiprone (DFP) vs deferasirox (DFX) in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation.
The DEEP-2 study will terminate when 388 patients will have been randomized. In order to meet this goal and allow newly activated centers to reach potential recruitment target, a further extension of enrollment has been granted until the end of April 2016. In this sense, a new center in Cyprus received the SIV on 26/02/2016 and is now ready to start the enrolment.
An important action carried out by the DEEP-2 Trial Management Team aimed at ensuring the correct implementation of study protocol is the release of a monthly DEEP-2 study newsletter (available on the DEEP website in the Study Newsletter section), that is sent to all PIs, with an update of the patients’ enrolment and the FAQ section, available on the website, aimed at clarifying most of the criticisms of the study protocol.