DEEP
DEferiprone Evaluation in Paediatrics
| Coordinatore | CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Organization address
address: VIA LUIGI PORTA 14 contact info |
| Nazionalità Coordinatore | Italy [IT] |
| Totale costo | 7˙626˙002 € |
| EC contributo | 5˙262˙963 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2010-single-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-01-01 - 2016-08-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Organization address
address: VIA LUIGI PORTA 14 contact info |
IT (PAVIA) | coordinator | 1˙569˙532.79 |
| 2 |
CAIRO UNIVERSITY
Organization address
address: AL ORMAN GUIZA contact info |
EG (GIZA) | participant | 681˙177.99 |
| 3 |
AZIENDA OSPEDALIERA OSPEDALI RIUNITI VILLA SOFIA-CERVELLO
Organization address
address: VIA STRASBURGO 233 contact info |
IT (PALERMO) | participant | 388˙582.94 |
| 4 |
AZIENDA OSPEDALIERA DI PADOVA
Organization address
address: Via Giustiniani 1 contact info |
IT (PADOVA) | participant | 323˙956.23 |
| 5 |
FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS
Organization address
address: VIA ABATE EUSTASIO 30 contact info |
IT (VALENZANO BARI) | participant | 293˙985.99 |
| 6 |
AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI
Organization address
address: PIAZZA GIULIO CESARE 11 contact info |
IT (BARI) | participant | 289˙646.05 |
| 7 |
CENTRE NATIONAL DE GREFFE DE MOELLE OSSEUSE
Organization address
address: RUE DJEBEL LAKHDAR 02 - BAB SAADOUN contact info |
TN (TUNIS) | participant | 276˙625.76 |
| 8 |
NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS
Organization address
address: CHRISTOU LADA 6 contact info |
EL (ATHENS) | participant | 267˙099.77 |
| 9 |
UNIVERSITATSKLINIKUM ERLANGEN
Organization address
address: Maximiliansplatz 2 contact info |
DE (ERLANGEN) | participant | 261˙512.80 |
| 10 |
UNIVERSITEIT LEIDEN
Organization address
address: RAPENBURG 70 contact info |
NL (LEIDEN) | participant | 245˙628.35 |
| 11 |
Ministry of Health of the Republic of Cyprus
Organization address
address: 1 Prodromou Street & 17 Chilonos Street 1 & 17 contact info |
CY (Nicosia) | participant | 197˙394.74 |
| 12 |
AZIENDA OSPEDALIERA ANTONIO CARDARE
Organization address
address: VIA ANTONIO CARDARELLI 9 contact info |
IT (Napoli) | participant | 187˙970.55 |
| 13 |
QENDER SPITALORE UNIVERSITARE NENEA TIRANE
Organization address
address: RR DIBRES 370 contact info |
AL (TIRANA) | participant | 162˙429.50 |
| 14 |
FONDAZIONE ITALIANA LEONARDO GIAMBRONE PER LA GUARIGIONE DELLA THALASSEMIA
Organization address
address: VIA GIROLAMO SAVONAROLA 19 contact info |
IT (ROMA) | participant | 95˙284.40 |
| 15 |
APO-PHARMA INC CORP
Organization address
address: SIGNET DRIVE 150 contact info |
CA (Toronto) | participant | 20˙500.00 |
| 16 |
"THE SCHOOL OF PHARMACY, UNIVERSITY OF LONDON"
Organization address
address: Brunswick Square 29-39 contact info |
UK (LONDON) | participant | 1˙635.14 |
| 17 |
APOTEX INC CORPORATION
Organization address
address: SIGNET DRIVE 150 contact info |
CA (TORONTO ONTARIO) | participant | 0.00 |
| 18 |
HOPITAL D'ENFANTS DE TUNIS
Organization address
address: Place Bab Saadoun contact info |
TN (Tunis) | participant | 0.00 |
Mappa
Word cloud
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Obiettivo del progetto (Objective)
'β-thalassaemia major is one of the most severe forms of chronic congenital anaemia. The recommended treatment consists in regular blood transfusions combined with chelating therapy to remove harmful iron accumulation in the body. The use of deferoxamine, the first chelating agent only available for subcutaneous administration is limited due to toxicity and the lack of compliance, despite its satisfactory therapeutic effects. An oral iron chelating agent, deferiprone, was authorised in Europe in August 1999 and recommended for the treatment of iron overload in patients with thalassaemia major when deferoxamine is contraindicated or inadequate. Despite a wide experience of the administration of deferiprone for thalassaemic patients, limited data are available on its use in children below 10 years and the need for additional data in this age subset was clearly indicated in the 2009 priority list approved by the Paediatric Committee at the European Medicines Agency (PDCO). In addition, according to the recent scientific advancements and in consideration of the anticipated benefit of this chelator in controlling cardiac iron overload, studies evaluating the effects of the deferiprone in all the paediatric ages and in all transfusion-dependent chronic congenital anaemia (including Sickle Cell Diseases) were also considered a critical therapeutic need. The DEEP project, in line with these premises, has been funded with the specific aim to produce a new oral liquid formulation of deferiprone suitable for the paediatric use and to provide evidences for the use of this chelator as first line therapy in the whole paediatric population (from 1 month to 18 years) affected by transfusion-dependent chronic anaemia. The condition under study in the DEEP project is rare. This poses special difficulties in the conduct of the studies due to the small patient population and the need to involve a large number of recruiting centres . However, being dedicated to develop an orphan drug, DEEP has been also recognised in the context of IRDiRC, the International Rare Diseases Research Consortium devoted to repurpose/develop 200 new drugs for Rare Diseases by the end of 2020. Main features of the DEEP project are: -The innovative design of the clinical studies including pharmacokinetic modelling for the definition of the most appropriate dosage of deferiprone in younger children, the cardiac MRI T2* evaluation as primary endpoint, a three years safety study aimed at evaluating deferiprone, in monotherapy or in combination, in the real world's setting and, for the first time, a comparative efficacy-safety trial to compare the two existing oral chelators: deferiprone and deferasirox. -The DEEP Consortium including European and non-European Countries from the Mediterranean region where the transfusion-dependent congenital anaemia, in particular β-thalassemia major, is particularly widespread: the collaboration within a multinational and multicultural network makes the Project extremely challenging due to many different ethical, methodological and social approaches to be explored and positively addressed.'
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