Calendario›SNY›GZ402665
GZ402665
A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
Ensayo de Sanofi en Sphingomyelin Lipidosis (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 25
- Centros
- 9
- Fin del objetivo primario
- sep 2023
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2013.
Qué mide
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) Except Infusion-Associated Reactions (IARs) (From the signature of informed consent up to 9 years or until olipudase alfa was commercially accessible, whichever came first) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this study was to obtain data regarding the safety of olipudase alfa in participants with acid sphingomyelinase deficiency (ASMD) who were exposed to long term treatment with olipudase alfa. The secondary objectives of this study were to obtain data regarding the efficacy of olipudase alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK) following long-term administration.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02004704), actualizada en jun 2024.