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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.
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.
Secondary ID [1] 0 0
2013-003458-26
Secondary ID [2] 0 0
CSLCT-HDL-12-77
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants With Clinically Important Change in Drug-induced Liver Injury
Timepoint [1] 0 0
From baseline (before first infusion) to Day 29.
Primary outcome [2] 0 0
Percent of Participants With Clinically Important Change in Renal Status
Timepoint [2] 0 0
From baseline (before first infusion) to Day 29.
Secondary outcome [1] 0 0
The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)
Timepoint [1] 0 0
From the start of the first infusion up to approximately 382 days
Secondary outcome [2] 0 0
Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants
Timepoint [2] 0 0
Before first infusion and end of first infusion
Secondary outcome [3] 0 0
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants
Timepoint [3] 0 0
Before first infusion and end of fourth infusion
Secondary outcome [4] 0 0
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function
Timepoint [4] 0 0
Before first infusion and end of first infusion
Secondary outcome [5] 0 0
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function
Timepoint [5] 0 0
Before first infusion and end of fourth infusion
Secondary outcome [6] 0 0
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment
Timepoint [6] 0 0
Before first infusion and end of first infusion
Secondary outcome [7] 0 0
Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment
Timepoint [7] 0 0
Before first infusion and end of fourth infusion
Secondary outcome [8] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants
Timepoint [8] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [9] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [9] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [10] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
Timepoint [10] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [11] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
Timepoint [11] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [12] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
Timepoint [12] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [13] 0 0
Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
Timepoint [13] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [14] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants
Timepoint [14] 0 0
Before and for 7 days after the first infusion
Secondary outcome [15] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [15] 0 0
Before and for 7 days after the fourth infusion
Secondary outcome [16] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
Timepoint [16] 0 0
Before and for 7 days after the first infusion
Secondary outcome [17] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
Timepoint [17] 0 0
Before and for 7 days after the fourth infusion
Secondary outcome [18] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
Timepoint [18] 0 0
Before and for 7 days after the first infusion
Secondary outcome [19] 0 0
Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
Timepoint [19] 0 0
Before and for 7 days after the fourth infusion
Secondary outcome [20] 0 0
Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants
Timepoint [20] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [21] 0 0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [21] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [22] 0 0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function
Timepoint [22] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [23] 0 0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
Timepoint [23] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [24] 0 0
Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment
Timepoint [24] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [25] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [26] 0 0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants
Timepoint [26] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [27] 0 0
Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [27] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [28] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [29] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [30] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [31] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [32] 0 0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After First Infusion for All Participants
Timepoint [32] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [33] 0 0
Change From Baseline in Plasma AUC0-8 for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [33] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [34] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [35] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [36] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [37] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [38] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [39] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [40] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [41] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [42] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [43] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [44] 0 0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants
Timepoint [44] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [45] 0 0
Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [45] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [46] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [47] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [48] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [49] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [50] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
Secondary outcome [51] 0 0
Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants
Timepoint [51] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [52] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [53] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
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
Timepoint [54] 0 0
Before first infusion (baseline) and for up to approximately 7 days after first infusion
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
Timepoint [55] 0 0
Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
Secondary outcome [56] 0 0
Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions
Timepoint [56] 0 0
From the start of first infusion, up to approximately Day 382
Secondary outcome [57] 0 0
Percent of Participants With Any Adverse Event (AE)
Timepoint [57] 0 0
From the start of first infusion, up to approximately Day 382
Secondary outcome [58] 0 0
Percent of Participants Who Experience Bleeding Events
Timepoint [58] 0 0
From the start of first infusion, up to approximately Day 112
Secondary outcome [59] 0 0
Change From Baseline in Serum Antibodies to CSL112 and apoA-I
Timepoint [59] 0 0
Before first infusion, up to approximately Day 112
Secondary outcome [60] 0 0
Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19
Timepoint [60] 0 0
Study Day 112
Secondary outcome [61] 0 0
Number of Participants With Parvovirus B19 DNA in Serum
Timepoint [61] 0 0
Study Day 112

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2016
Sample size
Target
Accrual to date
Final
1267
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Study Site 10002 - Herston
Recruitment hospital [2] 0 0
Study Site 10005 - Adelaide
Recruitment hospital [3] 0 0
Study Site 10012 - Woodville South
Recruitment hospital [4] 0 0
Study Site 10006 - Epping
Recruitment hospital [5] 0 0
Study Site 10007 - Geelong
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
South Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Austria
State/province [28] 0 0
Innsbruck
Country [29] 0 0
Austria
State/province [29] 0 0
Vienna
Country [30] 0 0
Austria
State/province [30] 0 0
Wien
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Blagoevgrad
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Burgas
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Dobrich
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Haskovo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Pazardzhik
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Pleven
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sandanski
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Sofia
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Varna
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Veliko Tarnovo
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Yambol
Country [43] 0 0
Canada
State/province [43] 0 0
Alberta
Country [44] 0 0
Canada
State/province [44] 0 0
British Columbia
Country [45] 0 0
Canada
State/province [45] 0 0
Newfoundland and Labrador
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Czechia
State/province [48] 0 0
Brno
Country [49] 0 0
Czechia
State/province [49] 0 0
Hradec Kralove
Country [50] 0 0
Czechia
State/province [50] 0 0
Jablonec nad Nisou
Country [51] 0 0
Czechia
State/province [51] 0 0
Jihlava
Country [52] 0 0
Czechia
State/province [52] 0 0
Kolin
Country [53] 0 0
Czechia
State/province [53] 0 0
Nachod
Country [54] 0 0
Czechia
State/province [54] 0 0
Ostrava
Country [55] 0 0
Czechia
State/province [55] 0 0
Pardubice
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha 10
Country [57] 0 0
Czechia
State/province [57] 0 0
Praha 2
Country [58] 0 0
Czechia
State/province [58] 0 0
Praha 4 - Krc
Country [59] 0 0
Czechia
State/province [59] 0 0
Praha 5
Country [60] 0 0
Czechia
State/province [60] 0 0
Teplice
Country [61] 0 0
Czechia
State/province [61] 0 0
Usti nad Orlici
Country [62] 0 0
Denmark
State/province [62] 0 0
Alborg
Country [63] 0 0
Denmark
State/province [63] 0 0
Esbjerg
Country [64] 0 0
Denmark
State/province [64] 0 0
Hellerup
Country [65] 0 0
Denmark
State/province [65] 0 0
Hvidovre
Country [66] 0 0
Denmark
State/province [66] 0 0
Odense
Country [67] 0 0
France
State/province [67] 0 0
Gironde
Country [68] 0 0
France
State/province [68] 0 0
Haute Garonne
Country [69] 0 0
France
State/province [69] 0 0
Loire Antlantique
Country [70] 0 0
France
State/province [70] 0 0
Paris
Country [71] 0 0
France
State/province [71] 0 0
Pyrenees Atlantiques
Country [72] 0 0
Germany
State/province [72] 0 0
Baden Wuerttemberg
Country [73] 0 0
Germany
State/province [73] 0 0
Berin
Country [74] 0 0
Germany
State/province [74] 0 0
Hessen
Country [75] 0 0
Germany
State/province [75] 0 0
Niedersachsen
Country [76] 0 0
Germany
State/province [76] 0 0
Nordrhein Westfalen
Country [77] 0 0
Germany
State/province [77] 0 0
Rheinland Pfalz
Country [78] 0 0
Germany
State/province [78] 0 0
Berlin
Country [79] 0 0
Germany
State/province [79] 0 0
Hamburg
Country [80] 0 0
Hungary
State/province [80] 0 0
Budapest
Country [81] 0 0
Hungary
State/province [81] 0 0
Gyor
Country [82] 0 0
Hungary
State/province [82] 0 0
Nyiregyhaza
Country [83] 0 0
Hungary
State/province [83] 0 0
Pecs
Country [84] 0 0
Hungary
State/province [84] 0 0
Szeged
Country [85] 0 0
Hungary
State/province [85] 0 0
Szolnok
Country [86] 0 0
Israel
State/province [86] 0 0
Ashkelon
Country [87] 0 0
Israel
State/province [87] 0 0
Beer Sheva
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Holon
Country [90] 0 0
Israel
State/province [90] 0 0
Jerusalem
Country [91] 0 0
Israel
State/province [91] 0 0
Nahariya
Country [92] 0 0
Israel
State/province [92] 0 0
Ramat Gan
Country [93] 0 0
Israel
State/province [93] 0 0
Safed
Country [94] 0 0
Italy
State/province [94] 0 0
Milano
Country [95] 0 0
Italy
State/province [95] 0 0
Benevento
Country [96] 0 0
Italy
State/province [96] 0 0
Napoli
Country [97] 0 0
Italy
State/province [97] 0 0
Rimini
Country [98] 0 0
Italy
State/province [98] 0 0
Roma
Country [99] 0 0
Italy
State/province [99] 0 0
Terni
Country [100] 0 0
Italy
State/province [100] 0 0
Udine
Country [101] 0 0
Netherlands
State/province [101] 0 0
Alkmaar
Country [102] 0 0
Netherlands
State/province [102] 0 0
Amsterdam
Country [103] 0 0
Netherlands
State/province [103] 0 0
Ede
Country [104] 0 0
Netherlands
State/province [104] 0 0
Leeuwarden
Country [105] 0 0
Netherlands
State/province [105] 0 0
Nieuwegein
Country [106] 0 0
Netherlands
State/province [106] 0 0
Nijmegen
Country [107] 0 0
Netherlands
State/province [107] 0 0
Rotterdam
Country [108] 0 0
Netherlands
State/province [108] 0 0
Sneek
Country [109] 0 0
Netherlands
State/province [109] 0 0
Tilburg
Country [110] 0 0
Netherlands
State/province [110] 0 0
Venlo
Country [111] 0 0
Poland
State/province [111] 0 0
Gdansk
Country [112] 0 0
Poland
State/province [112] 0 0
Grodzisk Mazowiecki
Country [113] 0 0
Poland
State/province [113] 0 0
Inowroclaw
Country [114] 0 0
Poland
State/province [114] 0 0
Kielce
Country [115] 0 0
Poland
State/province [115] 0 0
Krakow
Country [116] 0 0
Poland
State/province [116] 0 0
Lodz
Country [117] 0 0
Poland
State/province [117] 0 0
Starogard Gdanski
Country [118] 0 0
Poland
State/province [118] 0 0
Walbrzych
Country [119] 0 0
Poland
State/province [119] 0 0
Warszawa
Country [120] 0 0
Poland
State/province [120] 0 0
Wejherowo
Country [121] 0 0
Poland
State/province [121] 0 0
Wroclaw
Country [122] 0 0
Spain
State/province [122] 0 0
Barcelona
Country [123] 0 0
Spain
State/province [123] 0 0
La Coruna
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Malaga
Country [126] 0 0
Spain
State/province [126] 0 0
Tarragona
Country [127] 0 0
Spain
State/province [127] 0 0
Valencia
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Dunbartonshire
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Essex
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Greater London
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Leicestershire
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Tyne & Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT02108262
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Denise D'Andrea
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02108262