Calendario›SNY›Olipudase alfa
Olipudase alfa
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
Ensayo de Sanofi en Acid Sphingomyelinase Deficiency (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 3
- Centros
- 2
- Fin del objetivo primario
- abr 2025
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en nov 2021.
Qué mide
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From the signature of informed consent (Day 0) up to end of safety follow-up per participant, up to approximately 40 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632 Study in France until olipudase alfa reimbursement was granted in France. Study and treatment duration: The period between the participant's completion of Study DFI12712 or LTS13632 and olipudase alfa reimbursement was available in France. In case reimbursement was not obtained, this study ended 5 years after starting. Visit frequency: every 2 weeks.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06949358), actualizada en mar 2026.