Calendario›SNY›Olipudase alfa
Olipudase alfa
A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)
Ensayo de Sanofi en Niemann-Pick Diseases · Acid Sphingomyelinase Deficiency (del registro, en inglés).
- Fase
- no aplica
- Estado
- Reclutando pacientes
- Participantes
- 10
- Centros
- 6
- Fin del objetivo primario
- ene 2029
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en abr 2024.
Qué mide
Number of cases in the exposed population with AEs, SAEs, and AESIs (including moderate/severe or recurrent hypersensitivity reactions and infusion-associated reactions) (del registro, en inglés) (del inicio a los 3 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroUS, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care for acid sphingomyelinase deficiency (ASMD), but the study methodology remains non-interventional, as the additional collection of data from participants will not dictate treatment. The total overall study duration will be 5 years. The follow-up period will be a minimum of 1 year to a maximum of 3 years. The enrollment period will be up to 4 years, to allow a minimum of 1 year of follow-up for the last participant enrolled.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06192576), actualizada en sep 2026.