Study identification

EU PAS number

EUPAS3803

Study ID

12034

Official title and acronym

Long-term observational safety study to evaluate the nature and incidence of adverse effects of deferiprone treatment in patients with beta-thalassaemia major aged from 1 month to less than 18 years. (DEEP-3)

DARWIN EU® study

No

Study countries

Albania
Cyprus
Egypt
Greece
Italy
Tunisia

Study description

The overall aim of this multi-centre, observational cohort study is to investigate the long-term safety of deferiprone in children and adolescent. The main objectives are to evaluate the incidence of serious and non-serious adverse drug reactions in patients with beta-thalassaemia receiving deferiprone and being aged between one month and 18 years at initiation of treatment. All patients being treated with deferiprone at the participating centres will be included. Data will be collected both retrospectively and prospectively. Adverse drug reactions will be identified using intensive chart review and by clinicians reporting. Patients will be followed up to October 2015 or until cessation of deferiprone treatment, whatever comes first. Cumulative ADR incidence and ADR incidence rate will be calculated to determine the safety of deferiprone use. Multivariate logistic regression will be used to identify risk factors for adverse drug reactions to deferiprone.

Study status

Ongoing
Research institutions and networks

Institutions

Paediatric Clinical Study Centre,Department of Paediatric and Adolescents Medicine
Cairo University Faculty of Medicine Egypt, National And Kapodistrian University Of Athens Greece, Qendra Spitalore Universitare "Nene Tereza" Tirane Albania, Cyprus Ministry of Health, Nicosia Thalassaemia Center Cyprus, Centre national de Greffe de Moelle Osseuse Tunisia, Azienda Ospedaliera di Padova (Leading Centre in Italy) Italy, 10 additional centres Italy

Networks

DEEP Consortium (Coordinator: Consorzio per le Valutazioni Biologiche e Farmacologiche, CVBF, Pavia, Italy)

Contact details

Antje Neubert

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Actual:

Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
EU institutional research programme
Other

More details on funding

FP7 Grant HEALTH-F4-2010-261483, Participating Centres
Regulatory

Was the study required by a regulatory body?

No