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Caplacizumab
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Ensayo de Sanofi en Thrombotic Thrombocytopenic Purpura (del registro, en inglés).
- Fase
- Fase 2/3
- Estado
- Completado
- Participantes
- 21
- Centros
- 12
- Fin del objetivo primario
- may 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2019.
Qué mide
Proportion of participants with a recurrence of acquired thrombotic thrombocytopenic purpura (aTTP) (Approximately 2 months up to approximately 6 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period. Secondary Objectives: * To evaluate effect of caplacizumab on * prevention of recurrence of TTP (the number of recurrences of TTP) during overall study period. * a composite endpoint consisting of aTTP-related mortality, recurrence of aTTP and major thromboembolic events during study drug treatment * restoring platelet counts as a measure of prevention of further microvascular thrombosis * refractory disease * biomarkers of organ damage: LDH, cardiac troponin I, serum creatinine * plasma exchange (PE) parameters (days of PE and volume of plasma used), days in intensive care unit, days in hospital * cognitive status of Japanese patients * To evaluate safety profile of caplacizumab in Japanese patients * To evaluate effect of caplacizumab on pharmacodynamic (PD) markers in Japanese patients * To evaluate pharmacokinetic (PK) profile of caplacizumab in Japanese patients * To evaluate immunogenicity of caplacizumab in Japanese patients
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04074187), actualizada en sep 2025.