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Myozyme
Extension Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602
Ensayo de Sanofi en Glycogen Storage Disease Type II (del registro, en inglés).
- Fase
- Fase 2/3
- Estado
- Completado
- Participantes
- 16
- Centros
- 14
- Fin del objetivo primario
- jun 2006
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2005.
Qué mide
Long-term Safety and Efficacy (del registro, en inglés) (52 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.
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Ficha completa en ClinicalTrials.gov (NCT00125879), actualizada en feb 2014.