ホモ接合型家族性高コレステロール血症患者におけるエビナクマブの有効性と安全性

基本情報

NCT ID

NCT03399786

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

65

治験依頼者名

Regeneron Pharmaceuticals

概要

The 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.

対象疾患

介入

依頼者（Sponsor）