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

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Biological: Placebo; Biological: CSL112

Study type: Interventional

Funder types: Industry

Identifiers

NCT02108262

2013-003458-26 (EudraCT Number)

CSLCT-HDL-12-77

Details and patient eligibility

About

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).

Enrollment: 1,267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 week.

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,267 participants in 3 patient groups, including a placebo group

CSL112 - low dose

Experimental group

Description:

CSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.

Treatment:

Biological: CSL112

CSL112 - high dose

Experimental group

Description:

CSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.

Treatment:

Biological: CSL112

Placebo

Placebo Comparator group

Description:

Placebo is to be administered as an IV infusion at the same frequency, volume and duration as either the low dose or high dose CSL112 infusion.

Treatment:

Biological: Placebo