Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of ...
CSL112, human apoA-I formulated with phosphatidylcholine, is currently in a phase 3 clinical trial (AEGIS-II [ApoA-I Event Reducing in Ischemic Syndromes II]) to prevent major adverse cardiovascular events (MACE) in the 90-day high-risk period following myocardial infarction. Objective: To ...
The safety of CSL112 among AMI subjects with moderate, stage 3 chronic kidney disease (CKD) is unknown.CSL112_2001, a multicenter, placebo-controlled, parallel-group, double-blind, randomized phase 2 trial, enrolled patients with moderate CKD within 7 days following AMI. Enrollment was ...
3.C. Michael Gibson, et al. Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investi...
METHODS. This analysis included 50 patients with available samples from the AEGIS-I (ApoA-I Event Reducing in Ischemic Syndromes I) randomized, double-blind, placebo-controlled, phase 2b pharmacokinetic/pharmacodynamic sub-study (2). Patients were randomized to receive four weekly infusions of either...
In particular, CSL112 has been studied in the Phase 2b AEGIS trial exhibiting good safety and tolerability profiles, which has led to the ongoing large-scale Phase 3 AEGIS-II trial. This systematic overview will provide a comprehensive summary of the CSL112 drug development program focusing on ...
A Phase IIb trial (AEGIS-I; NCT02108262) of CSL112 in AMI patients is ongoing.doi:10.1161/circ.132.suppl_3.17135Alexandre M CukierSvetlana A DiditchenkoAlexei V NavdaevMartin O SpycherM J ChapmanSamuel D WrightAnatol KontushOvid Technologies (Wolters Kluwer Health)Circulation...
CSL112 (Apolipoprotein A‐I [human]) is an intravenous preparation of apolipoprotein A‐I (apoA‐I), formulated with phosphatidylcholine (PC) and stabilized with sucrose, in development to prevent early recurrent cardiovascular events following acute myocardial infarction (AMI). This phase 1 study ...
The aim of this phase 1 study was to assess the impact of moderate renal impairment on the pharmacokinetic and pharmacodynamic profile of CSL112. Sixteen subjects with moderate renal impairment and 16 age‐, sex‐, and weight‐matched subjects with normal renal function participated in the study....
CSL112 is a novel formulation of human plasma-derived apolipoprotein A-I (apoA-I), reconstituted with phosphatidylcholine and stabilized with sucrose that is currently being evaluated in a phase 3 clinical trial (AEGIS-II) for the reduction of major adverse CV events (MACE) in the period of ...