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Efanesoctocog Alfa BIVV001
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
Ensayo de Sanofi en Hemofilia A.
Más ensayos de: Hemofilia A.
- Fase
- no aplica
- Estado
- En marcha, sin reclutar
- Participantes
- 200
- Centros
- 28
- Fin del objetivo primario
- jun 2028
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en jun 2023.
Qué mide
Change from baseline in Annualized joint bleeding rate (AjBR) for treated bleeds (del registro, en inglés) (hasta 5 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan. Patients will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each study country. Decision to initiate treatment with commercially available efanesoctocog alfa will be made by the treating physician independently from the decision to include patients in the study. No study medication is provided. The data related to efanesoctocog alfa effectiveness, safety and usage will be collected prospectively during routine visits (expected annual/semi-annual visits) for up to 5 years following enrollment /treatment initiation.
Más ensayos de SNY
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|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05911763), actualizada en oct 2025.