CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,267 enrolled
Drug / intervention
CSL112 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02108262
NCT02108262Phase 2Completed
CompareCT.gov

A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

CSL Behring·interventional·Posted Apr 9, 2014·Updated Mar 15, 2021

In Brief

A Phase 2 clinical trial evaluating CSL112 and Placebo for Acute Myocardial Infarction. Completed, enrolled 1,267 participants across 189 sites in 16 countries.

Detailed Summary

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction
CountriesAustralia, Austria, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.2 years ago

Interventions

CSL112biological

CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.

Placebobiological

0.9% weight/volume sodium chloride solution (ie, normal saline)