Trials / Completed
CompletedNCT02108262
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,267 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-12-01
- Completion
- 2016-03-01
- First posted
- 2014-04-09
- Last updated
- 2021-03-15
- Results posted
- 2021-03-15
Locations
189 sites across 16 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02108262. Inclusion in this directory is not an endorsement.