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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myocardial Infarction

In brief

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).

Key facts

Study ID

NCT02108262

Run by

CSL Behring

People needed

1267

Starts

2014-08-01

Expected to finish

2016-03-01

Last updated by the study team

2021-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study Site 16078 — Huntsville, Alabama, United States
• Study Site - 16168 — Concord, California, United States
• Study Site 16168 — Concord, California, United States
• Study Site 16147 — Sacramento, California, United States
• Study Site 16022 — Torrance, California, United States
• Study Site 16130 — Littleton, Colorado, United States
• Study Site 16170 — Bridgeport, Connecticut, United States
• Study Site 16135 — Danbury, Connecticut, United States
• Study Site 16148 — Clearwater, Florida, United States
• Study Site 16003 — Jacksonville, Florida, United States
• Study Site 16144 — Atlanta, Georgia, United States
• Study Site 16112 — Boise, Idaho, United States
• Study Site 16060 — Evanston, Illinois, United States
• Study Site 16179 — Elkhart, Indiana, United States
• Study Site 16102 — Indianapolis, Indiana, United States
• Study Site 16025 — West Des Moines, Iowa, United States
• Study Site 16088 — Lexington, Kentucky, United States
• Study Site 16004 — Lexington, Kentucky, United States
• Study Site 16016 — Louisville, Kentucky, United States
• Study Site 16208 — Alexandria, Louisiana, United States
• Study Site 16062 — Auburn, Maine, United States
• Study Site 16079 — Bangor, Maine, United States
• Study Site 16031 — Baltimore, Maryland, United States
• Study Site 16028 — Detroit, Michigan, United States
• Study Site 16101 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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