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

• ClinicalTrials.gov Identifier: NCT02108262
• Recruitment Status: Completed
• First Posted: April 9, 2014
• Results First Posted: March 15, 2021
• Last Update Posted: March 15, 2021
• Sponsor: CSL Behring
• Information provided by (Responsible Party): CSL Behring

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Acute Myocardial Infarction	Biological: CSL112; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1267 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: August 2014
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: CSL112 - low dose; CSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.	Biological: CSL112; CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
Experimental: CSL112 - high dose; CSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.	Biological: CSL112; CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
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.	Biological: Placebo; 0.9% weight/volume sodium chloride solution (ie, normal saline)

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants With Clinically Important Change in Drug-induced Liver Injury [ Time Frame: From baseline (before first infusion) to Day 29. ]
   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.
2. Percent of Participants With Clinically Important Change in Renal Status [ Time Frame: From baseline (before first infusion) to Day 29. ]
   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.

Secondary Outcome Measures :

1. The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE) [ Time Frame: From the start of the first infusion up to approximately 382 days ]
   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.
2. Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants [ Time Frame: Before first infusion and end of first infusion ]
   Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112
3. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants [ Time Frame: Before first infusion and end of fourth infusion ]
4. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion and end of first infusion ]
   apoA-I and PC are analytes of CSL112
5. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion and end of fourth infusion ]
   apoA-I and PC are analytes of CSL112
6. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion and end of first infusion ]
   apoA-I and PC are analytes of CSL112
7. Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion and end of fourth infusion ]
   apoA-I and PC are analytes of CSL112
8. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
   Cmax is the maximal plasma concentration.
9. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
   Cmax is the maximal plasma concentration.
10. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    Cmax is the maximal plasma concentration.
11. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    Cmax is the maximal plasma concentration.
12. Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    Cmax is the maximal plasma concentration.
13. Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    Cmax is the maximal plasma concentration.
14. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before and for 7 days after the first infusion ]
    Tmax is time to maximal plasma concentration
15. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before and for 7 days after the fourth infusion ]
    Tmax is time to maximal plasma concentration
16. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before and for 7 days after the first infusion ]
    Tmax is time to maximal plasma concentration
17. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before and for 7 days after the fourth infusion ]
    Tmax is time to maximal plasma concentration
18. Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before and for 7 days after the first infusion ]
    Tmax is time to maximal plasma concentration
19. Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before and for 7 days after the fourth infusion ]
    Tmax is time to maximal plasma concentration
20. Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    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]
21. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    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]
22. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    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]
23. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    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]
24. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    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]
25. Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    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]
26. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC from baseline to time point t (AUC0-t)
27. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC from baseline to time point t (AUC0-t)
28. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC from baseline to time point t (AUC0-t)
29. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC from baseline to time point t (AUC0-t)
30. Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC from baseline to time point t (AUC0-t)
31. Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC from baseline to time point t (AUC0-t)
32. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
33. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
34. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
35. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
36. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
37. Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
    AUC0-∞ is plasma area under the curve (AUC0-infinity)
38. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
39. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
40. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
41. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
42. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
43. Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
44. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
45. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
46. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
47. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
48. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
49. Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
50. Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
51. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
52. Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
53. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
54. Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after first infusion ]
55. Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment [ Time Frame: Before first infusion (baseline) and for up to approximately 7 days after fourth infusion ]
56. Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions [ Time Frame: From the start of first infusion, up to approximately Day 382 ]

    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.
57. Percent of Participants With Any Adverse Event (AE) [ Time Frame: From the start of first infusion, up to approximately Day 382 ]
58. Percent of Participants Who Experience Bleeding Events [ Time Frame: From the start of first infusion, up to approximately Day 112 ]
    The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)
59. Change From Baseline in Serum Antibodies to CSL112 and apoA-I [ Time Frame: Before first infusion, up to approximately Day 112 ]
60. Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19 [ Time Frame: Study Day 112 ]
61. Number of Participants With Parvovirus B19 DNA in Serum [ Time Frame: Study Day 112 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Study Site 16101

Birmingham, Alabama, United States, 35211

Study Site 16078

Huntsville, Alabama, United States, 35801

United States, California

Study Site - 16168

Concord, California, United States, 94520

Study Site 16168

Concord, California, United States, 94520

Study Site 16147

Sacramento, California, United States, 95819

Study Site 16022

Torrance, California, United States, 90502

United States, Colorado

Study Site 16130

Littleton, Colorado, United States, 80120

United States, Connecticut

Study Site 16170

Bridgeport, Connecticut, United States, 06606

Study Site 16135

Danbury, Connecticut, United States, 06810

United States, Florida

Study Site 16148

Clearwater, Florida, United States, 33756

Study Site 16003

Jacksonville, Florida, United States, 32209

United States, Georgia

Study Site 16144

Atlanta, Georgia, United States, 30322

United States, Idaho

Study Site 16112

Boise, Idaho, United States, 83712

United States, Illinois

Study Site 16060

Evanston, Illinois, United States, 60201

United States, Indiana

Study Site 16179

Elkhart, Indiana, United States, 46514

Study Site 16102

Indianapolis, Indiana, United States, 46290

United States, Iowa

Study Site 16025

West Des Moines, Iowa, United States, 50266

United States, Kentucky

Study Site 16088

Lexington, Kentucky, United States, 40504

Study Site 16004

Lexington, Kentucky, United States, 40536

Study Site 16016

Louisville, Kentucky, United States, 40202

United States, Louisiana

Study Site 16208

Alexandria, Louisiana, United States, 71301

United States, Maine

Study Site 16062

Auburn, Maine, United States, 04210

Study Site 16079

Bangor, Maine, United States, 04401

United States, Maryland

Study Site 16031

Baltimore, Maryland, United States, 21215

United States, Michigan

Study Site 16028

Detroit, Michigan, United States, 48202

Study Site 16061

Petoskey, Michigan, United States, 49770

United States, Minnesota

Study Site 16211

Minneapolis, Minnesota, United States, 55407

Study Site 16234

Saint Paul, Minnesota, United States, 55102

United States, Mississippi

Study Site 16063

Tupelo, Mississippi, United States, 38801

United States, New York

Study Site 16033

Brooklyn, New York, United States, 11215

Study Site 16174

Buffalo, New York, United States, 14215

Study Site 16213

New York, New York, United States, 10029

United States, North Carolina

Study Site 16056

Durham, North Carolina, United States, 27705

Study Site 16201

Elizabeth City, North Carolina, United States, 27909

Study Site 16014

High Point, North Carolina, United States, 27262

Study Site 16024

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Study Site 16047

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

Study Site 16026

Hershey, Pennsylvania, United States, 17033

Study Site 16100

Lancaster, Pennsylvania, United States, 17604

Study Site 16017

Philadelphia, Pennsylvania, United States, 19104

United States, South Carolina

Study Site 16039

Greenwood, South Carolina, United States, 29646

United States, South Dakota

Study Site 16018

Rapid City, South Dakota, United States, 57701

United States, Tennessee

Study Site 16202

Greeneville, Tennessee, United States, 37745

United States, Texas

Study Site 16015

Amarillo, Texas, United States, 79106

Study Site 16099

Dallas, Texas, United States, 75216

Study Site 16241

Wichita Falls, Texas, United States, 76301

United States, Virginia

Study Site 16038

Richmond, Virginia, United States, 23298

United States, Wisconsin

Study Site 16166

Wausau, Wisconsin, United States, 54401

Australia, Queensland

Study Site 10002

Herston, Queensland, Australia, 4029

Australia, South Australia

Study Site 10005

Adelaide, South Australia, Australia, 5000

Study Site 10012

Woodville South, South Australia, Australia, 5011

Australia, Victoria

Study Site 10006

Epping, Victoria, Australia, 3076

Study Site 10007

Geelong, Victoria, Australia, 3220

Austria

Study Site 11004

Innsbruck, Austria, 6020

Study Site 11002

Vienna, Austria, 1090

Study Site 11001

Wien, Austria, 1160

Bulgaria

Study Site 12005

Blagoevgrad, Bulgaria, 2700

Study Site 12008

Burgas, Bulgaria, 8000

Study Site 12006

Dobrich, Bulgaria, 9300

Study Site 12021

Haskovo, Bulgaria, 6300

Study Site 12009

Pazardzhik, Bulgaria, 4400

Study Site 12019

Pazardzhik, Bulgaria, 4400

Study Site 12016

Pleven, Bulgaria, 5800

Study Site 12014

Plovdiv, Bulgaria, 4002

Study Site 12018

Plovdiv, Bulgaria, 4002

Study Site 12017

Sandanski, Bulgaria, 2800

Study Site 12003

Sofia, Bulgaria, 1233

Study Site 12001

Sofia, Bulgaria, 1309

Study Site 12004

Sofia, Bulgaria, 1407

Study Site 12012

Sofia, Bulgaria, 1407

Study Site 12010

Sofia, Bulgaria, 152

Study Site 12013

Sofia, Bulgaria, 1750

Study Site 12011

Varna, Bulgaria, 9010

Study Site 12002

Veliko Tarnovo, Bulgaria, 5000

Study Site 12007

Yambol, Bulgaria, 8600

Canada, Alberta

Study Site - 13003

Edmonton, Alberta, Canada, T5H 3V9

Study Site - 13002

Edmonton, Alberta, Canada, T6G 2B7

Canada, British Columbia

Study Site - 13017

Penticton, British Columbia, Canada, V2A 3G6

Study Site - 13012

Victoria, British Columbia, Canada, V8R 4R2

Canada, Newfoundland and Labrador

Study Site - 13019

St. Johns, Newfoundland and Labrador, Canada, A1B 3V6

Canada, Ontario

Study Site - 13008

London, Ontario, Canada, N6A 5A5

Study Site - 13010

Newmarket, Ontario, Canada, L3Y 2P7

Canada, Quebec

Study Site - 13014

Montreal, Quebec, Canada, H2W 1T8

Canada

Study Site - 13007

Quebec, Canada, G1V 4G5

Czechia

Study Site 14010

Brno, Czechia, 625 00

Study Site 14006

Brno, Czechia, 656 91

Study Site 14004

Hradec Kralove, Czechia, 500 05

Study Site 14012

Jablonec nad Nisou, Czechia, 466 60

Study Site 14011

Jihlava, Czechia, 586 33

Study Site 14016

Kolin, Czechia, 280 00

Study Site 14017

Nachod, Czechia, 547 01

Study Site 14007

Ostrava, Czechia, 708 52

Study Site 14003

Pardubice, Czechia, 532 03

Study Site 14002

Praha 10, Czechia, 100 34

Study Site 14001

Praha 2, Czechia, 128 08

Study Site 14015

Praha 2, Czechia, 128 08

Study Site 14008

Praha 4 - Krc, Czechia, 140 59

Study Site 14009

Praha 5, Czechia, 150 06

Study Site 14014

Teplice, Czechia, 415 01

Study Site 14005

Usti nad Orlici, Czechia, 562 18

Denmark

Study Site 15001

Alborg, Denmark, 9100

Study Site 15005

Esbjerg, Denmark, 6700

Study Site 15002

Hellerup, Denmark, 2900

Study Site 15004

Hvidovre, Denmark, 2650

Study Site 15003

Odense, Denmark, 5000

France

Study Site - 25003

Pessac, Gironde, France, 33604

Study Site - 25005

Toulouse cedex 3, Haute Garonne, France, 31076

Study Site - 25008

Nantes cedex, Loire Antlantique, France, 44093

Study Site - 25002

Paris cedex 12, Paris, France, 75571

Study Site - 25004

Pau, Pyrenees Atlantiques, France, 64046

Study Site - 25001

Paris, France, 75013

Germany

Study Site 17001

Freiburg, Baden Wuerttemberg, Germany, 79106

Study Site 17005

Berlin, Berin, Germany, 10249

Study Site 17014

Franfurt, Hessen, Germany, 65929

Study Site 17012

Hannover, Niedersachsen, Germany, 30625

Study Site 17007

Luedenscheid, Nordrhein Westfalen, Germany, 58509

Study Site 17010

Ludwigshafen, Rheinland Pfalz, Germany, 67063

Study Site 17011

Mainz, Rheinland Pfalz, Germany, 55131

Study Site 17003

Berlin, Germany, 10117

Study Site 17009

Berlin, Germany, 10967

Study Site 17002

Berlin, Germany, 12351

Study Site 17006

Hamburg, Germany, 20246

Hungary

Study Site 18008

Budapest, Hungary, 1023

Study Site 18001

Budapest, Hungary, 1122

Study Site 18005

Budapest, Hungary, 1134

Study Site 18002

Gyor, Hungary, 9024

Study Site 18007

Nyiregyhaza, Hungary, 4400

Study Site 18003

Pecs, Hungary, 7624

Study Site 18009

Szeged, Hungary, 6720

Study Site 18006

Szolnok, Hungary, 5000

Israel

Study Site 19010

Ashkelon, Israel, 7830604

Study Site 19006

Beer Sheva, Israel, 8410101

Study Site 19005

Haifa, Israel, 3109601

Study Site 19004

Holon, Israel, 5822012

Study Site 19003

Jerusalem, Israel, 91120

Study Site 19007

Jerusalem, Israel, 9124001

Study Site 19002

Nahariya, Israel, 2210001

Study Site 19009

Ramat Gan, Israel, 5262000

Study Site 19008

Safed, Israel, 13100

Italy

Study Site 20003

Legnano, Milano, Italy, 20025

Study Site 20002

Magenta, Milano, Italy, 20013

Study Site 20008

Rozzano, Milano, Italy, 20089

Study Site 20009

Benevento, Italy, 82100

Study Site 20011

Napoli, Italy, 80131

Study Site 20007

Rimini, Italy, 47923

Study Site 20012

Roma, Italy, 00189

Study Site 20001

Terni, Italy, 05100

Study Site 20006

Udine, Italy, 33100

Netherlands

Study Site 21001

Alkmaar, Netherlands, 1815 JD

Study Site 21006

Amsterdam, Netherlands, 091 AC

Study Site 21013

Amsterdam, Netherlands, 1081 HV

Study Site 21016

Amsterdam, Netherlands, 1105 AZ

Study Site 21004

Ede, Netherlands, 6716 RP

Study Site 21014

Leeuwarden, Netherlands, 8934 AD

Study Site 21003

Nieuwegein, Netherlands, 3435 CM

Study Site 21008

Nijmegen, Netherlands, 6525 EC

Study Site 21009

Rotterdam, Netherlands, 3079 DZ

Study Site 21010

Sneek, Netherlands, 8601 ZK

Study Site 21015

Tilburg, Netherlands, 5042 AD

Study Site 21011

Venlo, Netherlands, 5912 BL

Poland

Study Site - 22015

Gdansk, Poland, 80-952

Study Site - 22010

Grodzisk Mazowiecki, Poland, 05-825

Study Site - 22012

Inowroclaw, Poland, 88-10

Study Site 22009

Kielce, Poland, 25-736

Study Site - 22007

Krakow, Poland, 31-202

Study Site - 22014

Lodz, Poland, 91-347

Study Site - 22013

Starogard Gdanski, Poland, 83-200

Study Site - 22006

Walbrzych, Poland, 58-309

Study Site - 22008

Warszawa, Poland, 01-211

Study Site - 22016

Wejherowo, Poland, 84-200

Study Site - 22005

Wroclaw, Poland, 50-981

Spain

Study Site - 23010

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Study Site - 23012

A Coruna, La Coruna, Spain, 15006

Study Site - 23006

Santiago de Compostela, La Coruna, Spain, 15706

Study Site - 23005

Barcelona, Spain, 08003

Study Site - 23002

Barcelona, Spain, 08023

Study Site - 23001

Barcelona, Spain, 08036

Study Site - 23003

Madrid, Spain, 28007

Study Site - 23013

Madrid, Spain, 28034

Study Site - 23004

Madrid, Spain, 28040

Study Site - 23007

Malaga, Spain, 29010

Study Site - 23009

Tarragona, Spain, 43007

Study Site - 23011

Valencia, Spain, 46010

United Kingdom

Study Site - 24006

Clydebank, Dunbartonshire, United Kingdom, G81 1DY

Study Site - 24004

Basildon, Essex, United Kingdom, SS16 5NL

Study Site 24005

Romford, Essex, United Kingdom, UM7 0AG

Study Site - 24003

London, Greater London, United Kingdom, E2 9JX

Study Site - 24010

Leicester, Leicestershire, United Kingdom, LE3 9QP

Study Site - 24009

Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN

Sponsors and Collaborators

CSL Behring

Investigators

• Study Director: Dr. Denise D'Andrea; CSL Behring

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: CSL Behring
• ClinicalTrials.gov Identifier: NCT02108262
• Other Study ID Numbers: CSLCT-HDL-12-77; 2013-003458-26 ( EudraCT Number )
• First Posted: April 9, 2014
• Results First Posted: March 15, 2021
• Last Update Posted: March 15, 2021
• Last Verified: February 2021

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases