Calendario›SNY›Fitusiran · ATLAS-KIDS
Fitusiran · ATLAS-KIDS
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Ensayo de Sanofi en Hemofilia.
- Fase
- Fase 3
- Estado
- Reclutando pacientes
- Participantes
- 85
- Centros
- 30
- Fin del objetivo primario
- ago 2029
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en dic 2025.
Qué mide
Tasa anualizada de sangrado tratado (ABR) en el periodo de eficacia primaria de fitusiran y en el periodo de SOC (Day 85 to Day 421 (fitusiran primary efficacy period); Day -168 to Day -1 (SOC period)) (del registro, en inglés)
Qué se prueba
Se prueba fitusiran en participantes pediatricos varones de 1 a menos de 12 anos con hemofilia A o B grave, con o sin anticuerpos inhibidores, para evaluar la eficacia y seguridad de su administracion en profilaxis.
Lo que dice el documentoto evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to \<12 years) who have severe hemophilia A or B, with or without inhibitory antibodies to FVIII or FIX.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a parallel, Phase 3, two-arm, open-label study to evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to \<12 years) who have severe hemophilia A or B, with or without inhibitory antibodies to FVIII or FIX. Number of participants: Approximately 85 participants will be enrolled into the study: * Approximately 60 fitusiran-naïve participants with severe hemophilia A or B, with or without inhibitors (fitusiran-naïve arm), and * Approximately 25 participants with severe hemophilia A or B with inhibitors rolling over from the EFC15467\* dose confirmation study (roll-over arm). * Fitusiran has been investigated in the pediatric population in study EFC15467, which enrolled male participants aged 1 to \<12 years with hemophilia A or B with inhibitors to examine the safety and tolerability of fitusiran in the pediatric population. Participants will be enrolled into 1 of 2 arms: * Fitusiran-naïve: these participants have not previously received fitusiran, and they will undergo screening and study eligibility assessments. Once enrolled, they will go through a 24-week standard of care (SOC) period before starting fitusiran prophylaxis. * Roll-over participants from the EFC15467 study: only participants who are still on active treatment in study EFC15467 and consenting to study EFC17905 will be eligible to roll over. They will not need to undergo screening or further eligibility assessments. They will directly enroll into the fitusiran treatment period and continue treatment on their current fitusiran dose. The duration of fitusiran treatment will be up to 160 weeks for the fitusiran-naïve arm and up to 60 weeks for the roll-over arm.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT07285460), actualizada en ago 2026.