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BCX7353 · APeX-1

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

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

Fase

Fase 2

Estado

Completado

Participantes

75

previstos

Centros

24

Fin del objetivo primario

ago 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ago 2016.

Qué mide

Numero de ataques de AEH confirmados (Investigators collected data from patient diaries from the first day of dosing through to Day 29 or last day of dosing +24 hrs (the effective dosing period).) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

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Todos los de BCRX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02870972), actualizada en mar 2021.