Clinical trial NCT02108262: A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2014-04-09
Enrollment: 1267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants With Clinically Important Change in Drug-induced Liver Injury
timeFrame: From baseline (before first infusion) to Day 29.
measure: Percent of Participants With Clinically Important Change in Renal Status
timeFrame: From baseline (before first infusion) to Day 29.
Secondary outcomes:
measure: The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)
timeFrame: From the start of the first infusion up to approximately 382 days
measure: Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants
timeFrame: Before first infusion and end of first infusion
measure: Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants
timeFrame: Before first infusion and end of fourth infusion
measure: Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion and end of first infusion
measure: Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion and end of fourth infusion
measure: Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion and end of first infusion
measure: Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion and end of fourth infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants
timeFrame: Before and for 7 days after the first infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before and for 7 days after the fourth infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before and for 7 days after the first infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before and for 7 days after the fourth infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before and for 7 days after the first infusion
measure: Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before and for 7 days after the fourth infusion
measure: Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after first infusion
measure: Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment
timeFrame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion
measure: Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions
timeFrame: From the start of first infusion, up to approximately Day 382
measure: Percent of Participants With Any Adverse Event (AE)
timeFrame: From the start of first infusion, up to approximately Day 382
measure: Percent of Participants Who Experience Bleeding Events
timeFrame: From the start of first infusion, up to approximately Day 112
measure: Change From Baseline in Serum Antibodies to CSL112 and apoA-I
timeFrame: Before first infusion, up to approximately Day 112
measure: Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19
timeFrame: Study Day 112
measure: Number of Participants With Parvovirus B19 DNA in Serum
timeFrame: Study Day 112
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Site 16101
state: Alabama
city: Huntsville
country: United States
facility: Study Site 16078
state: Alabama
city: Concord
country: United States
facility: Study Site - 16168
state: California
city: Concord
country: United States
facility: Study Site 16168
state: California
city: Sacramento
country: United States
facility: Study Site 16147
state: California
city: Torrance
country: United States
facility: Study Site 16022
state: California
city: Littleton
country: United States
facility: Study Site 16130
state: Colorado
city: Bridgeport
country: United States
facility: Study Site 16170
state: Connecticut
city: Danbury
country: United States
facility: Study Site 16135
state: Connecticut
city: Clearwater
country: United States
facility: Study Site 16148
state: Florida
city: Jacksonville
country: United States
facility: Study Site 16003
state: Florida
city: Atlanta
country: United States
facility: Study Site 16144
state: Georgia
city: Boise
country: United States
facility: Study Site 16112
state: Idaho
city: Evanston
country: United States
facility: Study Site 16060
state: Illinois
city: Elkhart
country: United States
facility: Study Site 16179
state: Indiana
city: Indianapolis
country: United States
facility: Study Site 16102
state: Indiana
city: West Des Moines
country: United States
facility: Study Site 16025
state: Iowa
city: Lexington
country: United States
facility: Study Site 16088
state: Kentucky
city: Lexington
country: United States
facility: Study Site 16004
state: Kentucky
city: Louisville
country: United States
facility: Study Site 16016
state: Kentucky
city: Alexandria
country: United States
facility: Study Site 16208
state: Louisiana
city: Auburn
country: United States
facility: Study Site 16062
state: Maine
city: Bangor
country: United States
facility: Study Site 16079
state: Maine
city: Baltimore
country: United States
facility: Study Site 16031
state: Maryland
city: Detroit
country: United States
facility: Study Site 16028
state: Michigan
city: Petoskey
country: United States
facility: Study Site 16061
state: Michigan
city: Minneapolis
country: United States
facility: Study Site 16211
state: Minnesota
city: Saint Paul
country: United States
facility: Study Site 16234
state: Minnesota
city: Tupelo
country: United States
facility: Study Site 16063
state: Mississippi
city: Brooklyn
country: United States
facility: Study Site 16033
state: New York
city: Buffalo
country: United States
facility: Study Site 16174
state: New York
city: New York
country: United States
facility: Study Site 16213
state: New York
city: Durham
country: United States
facility: Study Site 16056
state: North Carolina
city: Elizabeth City
country: United States
facility: Study Site 16201
state: North Carolina
city: High Point
country: United States
facility: Study Site 16014
state: North Carolina
city: Winston-Salem
country: United States
facility: Study Site 16024
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site 16047
state: Ohio
city: Hershey
country: United States
facility: Study Site 16026
state: Pennsylvania
city: Lancaster
country: United States
facility: Study Site 16100
state: Pennsylvania
city: Philadelphia
country: United States
facility: Study Site 16017
state: Pennsylvania
city: Greenwood
country: United States
facility: Study Site 16039
state: South Carolina
city: Rapid City
country: United States
facility: Study Site 16018
state: South Dakota
city: Greeneville
country: United States
facility: Study Site 16202
state: Tennessee
city: Amarillo
country: United States
facility: Study Site 16015
state: Texas
city: Dallas
country: United States
facility: Study Site 16099
state: Texas
city: Wichita Falls
country: United States
facility: Study Site 16241
state: Texas
city: Richmond
country: United States
facility: Study Site 16038
state: Virginia
city: Wausau
country: United States
facility: Study Site 16166
state: Wisconsin
city: Herston
country: Australia
facility: Study Site 10002
state: Queensland
city: Adelaide
country: Australia
facility: Study Site 10005
state: South Australia
city: Woodville South
country: Australia
facility: Study Site 10012
state: South Australia
city: Epping
country: Australia
facility: Study Site 10006
state: Victoria
city: Geelong
country: Australia
facility: Study Site 10007
state: Victoria
city: Innsbruck
country: Austria
facility: Study Site 11004
city: Vienna
country: Austria
facility: Study Site 11002
city: Wien
country: Austria
facility: Study Site 11001
city: Blagoevgrad
country: Bulgaria
facility: Study Site 12005
city: Burgas
country: Bulgaria
facility: Study Site 12008
city: Dobrich
country: Bulgaria
facility: Study Site 12006
city: Haskovo
country: Bulgaria
facility: Study Site 12021
city: Pazardzhik
country: Bulgaria
facility: Study Site 12009
city: Pazardzhik
country: Bulgaria
facility: Study Site 12019
city: Pleven
country: Bulgaria
facility: Study Site 12016
city: Plovdiv
country: Bulgaria
facility: Study Site 12014
city: Plovdiv
country: Bulgaria
facility: Study Site 12018
city: Sandanski
country: Bulgaria
facility: Study Site 12017
city: Sofia
country: Bulgaria
facility: Study Site 12003
city: Sofia
country: Bulgaria
facility: Study Site 12001
city: Sofia
country: Bulgaria
facility: Study Site 12004
city: Sofia
country: Bulgaria
facility: Study Site 12012
city: Sofia
country: Bulgaria
facility: Study Site 12010
city: Sofia
country: Bulgaria
facility: Study Site 12013
city: Varna
country: Bulgaria
facility: Study Site 12011
city: Veliko Tarnovo
country: Bulgaria
facility: Study Site 12002
city: Yambol
country: Bulgaria
facility: Study Site 12007
city: Edmonton
country: Canada
facility: Study Site - 13003
state: Alberta
city: Edmonton
country: Canada
facility: Study Site - 13002
state: Alberta
city: Penticton
country: Canada
facility: Study Site - 13017
state: British Columbia
city: Victoria
country: Canada
facility: Study Site - 13012
state: British Columbia
city: St. Johns
country: Canada
facility: Study Site - 13019
state: Newfoundland and Labrador
city: London
country: Canada
facility: Study Site - 13008
state: Ontario
city: Newmarket
country: Canada
facility: Study Site - 13010
state: Ontario
city: Montreal
country: Canada
facility: Study Site - 13014
state: Quebec
city: Quebec
country: Canada
facility: Study Site - 13007
city: Brno
country: Czechia
facility: Study Site 14010
city: Brno
country: Czechia
facility: Study Site 14006
city: Hradec Kralove
country: Czechia
facility: Study Site 14004
city: Jablonec nad Nisou
country: Czechia
facility: Study Site 14012
city: Jihlava
country: Czechia
facility: Study Site 14011
city: Kolin
country: Czechia
facility: Study Site 14016
city: Nachod
country: Czechia
facility: Study Site 14017
city: Ostrava
country: Czechia
facility: Study Site 14007
city: Pardubice
country: Czechia
facility: Study Site 14003
city: Praha 10
country: Czechia
facility: Study Site 14002
city: Praha 2
country: Czechia
facility: Study Site 14001
city: Praha 2
country: Czechia
facility: Study Site 14015
city: Praha 4 - Krc
country: Czechia
facility: Study Site 14008
city: Praha 5
country: Czechia
facility: Study Site 14009
city: Teplice
country: Czechia
facility: Study Site 14014
city: Usti nad Orlici
country: Czechia
facility: Study Site 14005
city: Alborg
country: Denmark
facility: Study Site 15001
city: Esbjerg
country: Denmark
facility: Study Site 15005
city: Hellerup
country: Denmark
facility: Study Site 15002
city: Hvidovre
country: Denmark
facility: Study Site 15004
city: Odense
country: Denmark
facility: Study Site 15003
city: Pessac
country: France
facility: Study Site - 25003
state: Gironde
city: Toulouse cedex 3
country: France
facility: Study Site - 25005
state: Haute Garonne
city: Nantes cedex
country: France
facility: Study Site - 25008
state: Loire Antlantique
city: Paris cedex 12
country: France
facility: Study Site - 25002
state: Paris
city: Pau
country: France
facility: Study Site - 25004
state: Pyrenees Atlantiques
city: Paris
country: France
facility: Study Site - 25001
city: Freiburg
country: Germany
facility: Study Site 17001
state: Baden Wuerttemberg
city: Berlin
country: Germany
facility: Study Site 17005
state: Berin
city: Franfurt
country: Germany
facility: Study Site 17014
state: Hessen
city: Hannover
country: Germany
facility: Study Site 17012
state: Niedersachsen
city: Luedenscheid
country: Germany
facility: Study Site 17007
state: Nordrhein Westfalen
city: Ludwigshafen
country: Germany
facility: Study Site 17010
state: Rheinland Pfalz
city: Mainz
country: Germany
facility: Study Site 17011
state: Rheinland Pfalz
city: Berlin
country: Germany
facility: Study Site 17003
city: Berlin
country: Germany
facility: Study Site 17009
city: Berlin
country: Germany
facility: Study Site 17002
city: Hamburg
country: Germany
facility: Study Site 17006
city: Budapest
country: Hungary
facility: Study Site 18008
city: Budapest
country: Hungary
facility: Study Site 18001
city: Budapest
country: Hungary
facility: Study Site 18005
city: Gyor
country: Hungary
facility: Study Site 18002
city: Nyiregyhaza
country: Hungary
facility: Study Site 18007
city: Pecs
country: Hungary
facility: Study Site 18003
city: Szeged
country: Hungary
facility: Study Site 18009
city: Szolnok
country: Hungary
facility: Study Site 18006
city: Ashkelon
country: Israel
facility: Study Site 19010
city: Beer Sheva
country: Israel
facility: Study Site 19006
city: Haifa
country: Israel
facility: Study Site 19005
city: Holon
country: Israel
facility: Study Site 19004
city: Jerusalem
country: Israel
facility: Study Site 19003
city: Jerusalem
country: Israel
facility: Study Site 19007
city: Nahariya
country: Israel
facility: Study Site 19002
city: Ramat Gan
country: Israel
facility: Study Site 19009
city: Safed
country: Israel
facility: Study Site 19008
city: Legnano
country: Italy
facility: Study Site 20003
state: Milano
city: Magenta
country: Italy
facility: Study Site 20002
state: Milano
city: Rozzano
country: Italy
facility: Study Site 20008
state: Milano
city: Benevento
country: Italy
facility: Study Site 20009
city: Napoli
country: Italy
facility: Study Site 20011
city: Rimini
country: Italy
facility: Study Site 20007
city: Roma
country: Italy
facility: Study Site 20012
city: Terni
country: Italy
facility: Study Site 20001
city: Udine
country: Italy
facility: Study Site 20006
city: Alkmaar
country: Netherlands
facility: Study Site 21001
city: Amsterdam
country: Netherlands
facility: Study Site 21006
city: Amsterdam
country: Netherlands
facility: Study Site 21013
city: Amsterdam
country: Netherlands
facility: Study Site 21016
city: Ede
country: Netherlands
facility: Study Site 21004
city: Leeuwarden
country: Netherlands
facility: Study Site 21014
city: Nieuwegein
country: Netherlands
facility: Study Site 21003
city: Nijmegen
country: Netherlands
facility: Study Site 21008
city: Rotterdam
country: Netherlands
facility: Study Site 21009
city: Sneek
country: Netherlands
facility: Study Site 21010
city: Tilburg
country: Netherlands
facility: Study Site 21015
city: Venlo
country: Netherlands
facility: Study Site 21011
city: Gdansk
country: Poland
facility: Study Site - 22015
city: Grodzisk Mazowiecki
country: Poland
facility: Study Site - 22010
city: Inowroclaw
country: Poland
facility: Study Site - 22012
city: Kielce
country: Poland
facility: Study Site 22009
city: Krakow
country: Poland
facility: Study Site - 22007
city: Lodz
country: Poland
facility: Study Site - 22014
city: Starogard Gdanski
country: Poland
facility: Study Site - 22013
city: Walbrzych
country: Poland
facility: Study Site - 22006
city: Warszawa
country: Poland
facility: Study Site - 22008
city: Wejherowo
country: Poland
facility: Study Site - 22016
city: Wroclaw
country: Poland
facility: Study Site - 22005
city: L'Hospitalet de Llobregat
country: Spain
facility: Study Site - 23010
state: Barcelona
city: A Coruna
country: Spain
facility: Study Site - 23012
state: La Coruna
city: Santiago de Compostela
country: Spain
facility: Study Site - 23006
state: La Coruna
city: Barcelona
country: Spain
facility: Study Site - 23005
city: Barcelona
country: Spain
facility: Study Site - 23002
city: Barcelona
country: Spain
facility: Study Site - 23001
city: Madrid
country: Spain
facility: Study Site - 23003
city: Madrid
country: Spain
facility: Study Site - 23013
city: Madrid
country: Spain
facility: Study Site - 23004
city: Malaga
country: Spain
facility: Study Site - 23007
city: Tarragona
country: Spain
facility: Study Site - 23009
city: Valencia
country: Spain
facility: Study Site - 23011
city: Clydebank
country: United Kingdom
facility: Study Site - 24006
state: Dunbartonshire
city: Basildon
country: United Kingdom
facility: Study Site - 24004
state: Essex
city: Romford
country: United Kingdom
facility: Study Site 24005
state: Essex
city: London
country: United Kingdom
facility: Study Site - 24003
state: Greater London
city: Leicester
country: United Kingdom
facility: Study Site - 24010
state: Leicestershire
city: Newcastle upon Tyne
country: United Kingdom
facility: Study Site - 24009
state: Tyne & Wear
Study officials:
affiliation: CSL Behring
name: Dr. Denise D'Andrea
role: STUDY_DIRECTOR
References:
citation: 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.
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