An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy
TerminadoFase 3ClinicalTrials.gov
ID: NCT01480245Tipo: INTERVENTIONALInicio: 1 de sept de 2011Fin estimado: 1 de mar de 2014
Traducción no disponible, mostrando original
Resumen
The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.
Elegibilidad
Edad mínima: 5 YearsSexo: MALE
Criterios de inclusión
Previous participation in either DMD114117 or DMD114044
Continued use of glucocorticoids
Willing and able to comply with all protocol requirements
Able to give informed consent
French subjects: Eligible for inclusion only if either affiliated to or a beneficiary of a social security category.
Criterios de exclusión
Subject experienced a serious adverse event or who met safety stopping criteria that remains unresolved from DMD114117 or DMD114044, which in opinion of the investigator could have been attributable to study medication and is ongoing,
Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs,except GSK2402968, within 1 month of the first administration of study medication,
Current or anticipated participation in any investigational clinical studies,
History of significant medical disorder which may confound the interpretation of either efficacy or safety data e.g. current history of renal or liver disease/impairment, history of inflammatory disease.
Intervenciones
drug
GSK2402968
6mg/kg/week
Ubicaciones
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Patrocinadores
PrincipalGlaxoSmithKline
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