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A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

NCT02108262 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1267

Last updated 2021-03-15

Study results available
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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).

Conditions

  • Acute Myocardial Infarction

Interventions

BIOLOGICAL

CSL112

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Dr. Denise D'Andrea · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02108262 on ClinicalTrials.gov