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SAGHE

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Cerrado

Safety and Appropriateness of Growth hormone treatments in Europe

Recombinant growth hormone (GH) has been used since 1985. Current indications for GH use in children include GH deficiency and an increasing number of conditions where childhood short stature is not primarily due to deficient GH s... ver más

30/11/2012

ASSISTANCE PUBLIQU...

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 11 Participantes

Financiación concedida El organismo FP7 notifico la concesión del proyecto el día 2012-11-30 No tenemos la información de la convocatoria

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

11 Participantes

ASSISTANCE PUBLIQUE HOPITAUX...

0.00€ | Lider

ICR

N.D. | Participante

ULEI

N.D. | Participante

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Líder del proyecto

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 4M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Recombinant growth hormone (GH) has been used since 1985. Current indications for GH use in children include GH deficiency and an increasing number of conditions where childhood short stature is not primarily due to deficient GH secretion. Approximately 40 000 children in the EU are treated with daily injections of GH. The efficacy of GH to increase adult height is undisputed in children with severe GH deficiency but is more limited in other indications where current estimates suggest a gain of about 1 cm of adult height per year of treatment. The clinical significance of height gains has been poorly evaluated. The possibility has been raised that GH use in childhood might increase the risk of cancer later in life. However, little data is available to further explore this concern. SAGhE is an integrated consortium of paediatric endocrinologist, epidemiologists and biostatisticians that will collect and analyse data to address the questions of appropriateness and safety of childhood GH treatments. The impact on both height and psychosocial components will be evaluated on a large unbiased metacohort of patients followed to adult height. Safety will be evaluated by analysing long term mortality and long term cancer incidence. The data obtained will then be integrated and disseminated to several levels of users. SAGhE will contribute to the aims of the FP7 Health work programme and to the new Community Action programme of public Health in the field of better use of medicines. It will realize the application of evidence-based medicine in Europe, by the size and design of the study, the independence and scientific quality of data analysis and its translation into evidence-based guidelines. It will be comprehensive at the EU level and will test for national differences. It will address patient safety, one of the key points of the work programme. SAGhE is unique worldwide in its design, size and potential to answer important questions raised on childhood GH treatments.

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