A Phase 2b study of CSL112 in subjects with acute myocardial infarction.
- Conditions
- Acute Myocardial InfarctionMedDRA version: 17.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-003458-26-ES
- Lead Sponsor
- CSL Behring LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
? 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.
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
? 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method