A Phase 2b study of CSL112 in subjects with acute myocardial infarction.

Phase 1

• Conditions: Acute Myocardial Infarction; MedDRA version: 16.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003458-26-IT
• Lead Sponsor: CSL Behring LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last four days.
1. Detection of a rise and/or fall cardiac troponin I or T with at least one
value above the 99th percentile upper reference limit.
AND,
2. Any one or more of the following:
a. Symptoms of ischemia
b. New (or presumably new) significant ST/T wave changes or
left bundle-branch block (LBBB)
c. Development of pathological Q waves on ECG
d. Imaging evidence of new loss of viable myocardium or
regional wall motion abnormality
e. Identification of intracoronary thrombus by angiography
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 780
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

Exclusion Criteria

• Ongoing hemodynamic instability
• Evidence of hepatobiliary disease
• Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
• Evidence of unstable renal function
• History of acute kidney injury after previous exposure to an intravenous contrast agent.
• Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
• Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified