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BCX7353

Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema

Ensayo de BIOCRYST PHARMACEUTICALS INC en Angioedema hereditario (AEH).

Fase

Fase 2

Estado

Completado

Participantes

58

previstos

Centros

24

Fin del objetivo primario

ene 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en jul 2017.

Qué mide

Proporcion de sujetos con puntuacion compuesta de escala visual analogica (EVA) mejorada o estable (Mean composite VAS for HAE attack symptoms severity prior to IMP treatment and 4 hours post-dose) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

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Todos los de BCRX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03240133), actualizada en mar 2021.