Calendario›REGN›evinacumab

evinacumab

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Ensayo de REGENERON PHARMACEUTICALS, INC. en Homozygous Familial Hypercholesterolemia (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

65

previstos

Centros

30

Fin del objetivo primario

jun 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2018.

Qué mide

Percent Change in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 24 (Intent-to-Treat [ITT] Estimand) (del registro, en inglés) (semana 24)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03399786), actualizada en abr 2021.