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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02108262
Registration number
NCT02108262
Ethics application status
Date submitted
31/03/2014
Date registered
9/04/2014
Date last updated
15/03/2021
Titles & IDs
Public title
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
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Scientific title
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.
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Secondary ID [1]
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2013-003458-26
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Secondary ID [2]
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CSLCT-HDL-12-77
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - CSL112
Treatment: Other - Placebo
Experimental: CSL112 - low dose - CSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.
Experimental: CSL112 - high dose - CSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.
Placebo comparator: Placebo - 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: Other: 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.
Treatment: Other: Placebo
0.9% weight/volume sodium chloride solution (ie, normal saline)
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent of Participants With Clinically Important Change in Drug-induced Liver Injury
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Assessment method [1]
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A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement.
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Timepoint [1]
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From baseline (before first infusion) to Day 29.
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Primary outcome [2]
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Percent of Participants With Clinically Important Change in Renal Status
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Assessment method [2]
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A clinically important change in renal status is defined as a serum creatinine (Cr) increase to = 1.5 x the baseline value that is confirmed upon repeat measurement.
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Timepoint [2]
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From baseline (before first infusion) to Day 29.
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Secondary outcome [1]
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The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)
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Assessment method [1]
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The MACE is a 4-component composite comprised of the time to the first of the following events: CV death, nonfatal myocardial infarction, ischemic stroke (non-hemorrhagic), and hospitalization for unstable angina.
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Timepoint [1]
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From the start of the first infusion up to approximately 382 days
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Secondary outcome [2]
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Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants
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Assessment method [2]
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Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112
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Timepoint [2]
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Before first infusion and end of first infusion
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Secondary outcome [3]
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Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants
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Assessment method [3]
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0
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Timepoint [3]
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Before first infusion and end of fourth infusion
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Secondary outcome [4]
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Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function
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Assessment method [4]
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apoA-I and PC are analytes of CSL112
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Timepoint [4]
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Before first infusion and end of first infusion
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Secondary outcome [5]
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Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function
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Assessment method [5]
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apoA-I and PC are analytes of CSL112
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Timepoint [5]
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Before first infusion and end of fourth infusion
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Secondary outcome [6]
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Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment
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Assessment method [6]
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apoA-I and PC are analytes of CSL112
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Timepoint [6]
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0
Before first infusion and end of first infusion
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Secondary outcome [7]
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Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [7]
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apoA-I and PC are analytes of CSL112
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Timepoint [7]
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0
Before first infusion and end of fourth infusion
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Secondary outcome [8]
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Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants
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Assessment method [8]
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Cmax is the maximal plasma concentration.
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Timepoint [8]
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Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [9]
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Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [9]
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Cmax is the maximal plasma concentration.
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Timepoint [9]
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Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [10]
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Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [10]
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Cmax is the maximal plasma concentration.
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Timepoint [10]
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Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [11]
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Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [11]
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Cmax is the maximal plasma concentration.
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Timepoint [11]
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Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [12]
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Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [12]
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Cmax is the maximal plasma concentration.
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Timepoint [12]
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Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [13]
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Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [13]
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Cmax is the maximal plasma concentration.
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Timepoint [13]
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Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [14]
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Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants
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Assessment method [14]
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Tmax is time to maximal plasma concentration
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Timepoint [14]
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Before and for 7 days after the first infusion
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Secondary outcome [15]
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Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [15]
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Tmax is time to maximal plasma concentration
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Timepoint [15]
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Before and for 7 days after the fourth infusion
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Secondary outcome [16]
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Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [16]
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Tmax is time to maximal plasma concentration
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Timepoint [16]
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Before and for 7 days after the first infusion
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Secondary outcome [17]
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Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [17]
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Tmax is time to maximal plasma concentration
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Timepoint [17]
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0
Before and for 7 days after the fourth infusion
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Secondary outcome [18]
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Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [18]
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Tmax is time to maximal plasma concentration
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Timepoint [18]
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Before and for 7 days after the first infusion
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Secondary outcome [19]
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Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [19]
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Tmax is time to maximal plasma concentration
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Timepoint [19]
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Before and for 7 days after the fourth infusion
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Secondary outcome [20]
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Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants
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Assessment method [20]
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Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [20]
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Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [21]
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Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [21]
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0
Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [21]
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0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [22]
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0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [22]
0
0
Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [22]
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0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [23]
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0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [23]
0
0
Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [23]
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0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [24]
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0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment
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Assessment method [24]
0
0
Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [24]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [25]
0
0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [25]
0
0
Area under the plasma concentration time curve (AUC) from time point zero (baseline) to the last quantifiable time-point before the analyte first returns to baseline \[AUC0 - last\]
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Timepoint [25]
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0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [26]
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Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants
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Assessment method [26]
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AUC from baseline to time point t (AUC0-t)
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Timepoint [26]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [27]
0
0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [27]
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AUC from baseline to time point t (AUC0-t)
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Timepoint [27]
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0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [28]
0
0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [28]
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0
AUC from baseline to time point t (AUC0-t)
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Timepoint [28]
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0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [29]
0
0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [29]
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0
AUC from baseline to time point t (AUC0-t)
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Timepoint [29]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [30]
0
0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [30]
0
0
AUC from baseline to time point t (AUC0-t)
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Timepoint [30]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [31]
0
0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [31]
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0
AUC from baseline to time point t (AUC0-t)
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Timepoint [31]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [32]
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Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for All Participants
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Assessment method [32]
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AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [32]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [33]
0
0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [33]
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0
AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [33]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [34]
0
0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [34]
0
0
AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [34]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [35]
0
0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [35]
0
0
AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [35]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [36]
0
0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [36]
0
0
AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [36]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [37]
0
0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [37]
0
0
AUC0-8 is plasma area under the curve (AUC0-infinity)
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Timepoint [37]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [38]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants
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Assessment method [38]
0
0
Query!
Timepoint [38]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [39]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [39]
0
0
Query!
Timepoint [39]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [40]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [41]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [41]
0
0
Query!
Timepoint [41]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [42]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [42]
0
0
Query!
Timepoint [42]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [43]
0
0
Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [44]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants
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Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [45]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [46]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [46]
0
0
Query!
Timepoint [46]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [47]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [47]
0
0
Query!
Timepoint [47]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [48]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [49]
0
0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [50]
0
0
Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants
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Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [51]
0
0
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants
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Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [52]
0
0
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function
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Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [53]
0
0
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
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Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [54]
0
0
Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
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Assessment method [54]
0
0
Query!
Timepoint [54]
0
0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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Secondary outcome [55]
0
0
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
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Assessment method [55]
0
0
Query!
Timepoint [55]
0
0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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Secondary outcome [56]
0
0
Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions
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Assessment method [56]
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0
The overall percentage of subjects:
* with adverse events (AEs), including local tolerability events, that begin during or within 1 hour of an infusion; or
* with AEs considered to be causally related to the test product; or
* who experience an AE for which the incidence rate in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.
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Timepoint [56]
0
0
From the start of first infusion, up to approximately Day 382
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Secondary outcome [57]
0
0
Percent of Participants With Any Adverse Event (AE)
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Assessment method [57]
0
0
Query!
Timepoint [57]
0
0
From the start of first infusion, up to approximately Day 382
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Secondary outcome [58]
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0
Percent of Participants Who Experience Bleeding Events
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Assessment method [58]
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0
The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)
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Timepoint [58]
0
0
From the start of first infusion, up to approximately Day 112
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Secondary outcome [59]
0
0
Change From Baseline in Serum Antibodies to CSL112 and apoA-I
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Assessment method [59]
0
0
Query!
Timepoint [59]
0
0
Before first infusion, up to approximately Day 112
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Secondary outcome [60]
0
0
Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19
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Assessment method [60]
0
0
Query!
Timepoint [60]
0
0
Study Day 112
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Secondary outcome [61]
0
0
Number of Participants With Parvovirus B19 DNA in Serum
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Assessment method [61]
0
0
Query!
Timepoint [61]
0
0
Study Day 112
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2016
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Sample size
Target
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Accrual to date
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Final
1267
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Study Site 10002 - Herston
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Study Site 10005 - Adelaide
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Study Site 10012 - Woodville South
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Study Site 10007 - Geelong
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4029 - Herston
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5000 - Adelaide
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5011 - Woodville South
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Recruitment postcode(s) [4]
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3076 - Epping
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment outside Australia
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Germany
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Tyne & Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
CSL Behring
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02108262
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Trial related presentations / publications
Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23. Michael Gibson C, Korjian S, Tricoci P, Daaboul Y, Yee M, Jain P, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea DM, Deckelbaum LI, Merkely B, Zarebinski M, Ophuis TO, Harrington RA. Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I). Circulation. 2016 Dec 13;134(24):1918-1930. doi: 10.1161/CIRCULATIONAHA.116.025687. Epub 2016 Nov 15. Gibson CM, Korjian S, Tricoci P, Daaboul Y, Alexander JH, Steg PG, Lincoff AM, Kastelein JJ, Mehran R, D'Andrea D, Merkely B, Zarebinski M, Ophius TO, Harrington RA. Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction. Am Heart J. 2016 Oct;180:22-8. doi: 10.1016/j.ahj.2016.06.017. Epub 2016 Jul 5.
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Public notes
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Contacts
Principal investigator
Name
0
0
Dr. Denise D'Andrea
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Address
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CSL Behring
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Fax
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0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02108262
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