The 5th DEEP General Assembly took place from the 3rd to the 5th of July 2014 in the legendary city of Athens, Greece, with the participation of the whole DEEP Consortium as well as external experts. The main contents presented and discussed are summarized below.
Session I: DEEP-1 Results
The meeting opened with the presentation of the results of the pharmacokinetic study (DEEP-1 trial) and their impact on the DEEP-2 study conduct. The collected data provide valuable information on the correct dosage of deferiprone to be administered to children below 6 years of age. Although multicentre trials are particularly difficult for PK evaluations, the team congratulates the investigators and all the study staff as data collected within DEEP-1 are excellent.
Session II: Organization of the DEEP-2 Trial
The DEEP-2 trial implementation, in terms of authorisation process and status, IMPs distribution, technical facilities was discussed. Moreover, the psychological sub-study to investigate parents’ behaviour during the DEEP-2 recruitment phase was presented. The main questions and queries arisen during the first weeks of recruitment were discussed and common actions/solutions were shared and agreed upon and included in the DEEP-2 FAQ.
Session III: DEEP-2 Recruiting Centres
The importance to adopt proper communication strategies and flows between the Sponsor’s staff and Investigators’ team, even when face-to-face interactions are not possible, was stressed in order to guarantee the best management of each trial procedure. In particular, the monitoring procedures to be carried out were described and the experience of the already performed monitoring visits with the most challenging issues was shared.
Session IV: DEEP-3 Long Term Safety Study
After the presentation of the preliminary results and the criteria for Adverse Drug Reaction and Adverse Events assessment, the discussion focussed on the slow recruitment process observed so far. Strategies to accelerate recruitment were discussed. Sample size calculation based on the number of patients and patients’ age is proposed and will be conducted in the following weeks. Moreover it was clarified that any use of deferiprone both as monotherapy and in combination will deferoxamine is currently included in the protocol.
Scientific Open Session
The GA presented the opportunity to hold an open Scientific Meeting on July 5th, which focussed on specific topics of interest in the field of iron chelators and iron overload where eminent scientists and experts provided an overview of:
– the new paediatric clinical trial regulation;
– the main features of deferiprone therapy, either alone or in combined regimen, in terms of safety, efficacy and significant clinical evidence in hepatic and cardiac iron overload;
– the management of iron overload in Sickle Cell Disease;
– the importance of Magnetic Resonance Imaging analysis;
– the new therapies for the treatment of Hepatitis C virus Infection.