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Drisapersen

A Study of the Safety, Tolerability & Efficacy of Long-term Administration of Drisapersen in US & Canadian Subjects

Ensayo de BIOMARIN PHARMACEUTICAL INC en Distrofias musculares.

Más ensayos de: Distrofias musculares.

Fase

Fase 3

Estado

Interrumpido

Participantes

53

previstos

Centros

13

Fin del objetivo primario

jun 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2013.

Qué mide

Incidencia y gravedad de acontecimientos adversos (AA) (hasta 48 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a phase III, multicenter, open-label, uncontrolled extension study in male subjects with DMD open to eligible US and Canadian subjects who previously participated in the following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive 6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously experienced significant safety or tolerability issues or who experience these during the study, there is the potential of an alternate intermittent dosing arm that will be given as a regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who experience or have previously experienced significant safety/tolerability issues, side effects or reactions or intermittent dosing, intravenous dosing will be made available.

Más ensayos de BMRN

Todos los de BMRN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01803412), actualizada en jun 2018.