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

Primary Purpose

Acute Myocardial Infarction

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CSL112

Placebo

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

CSL112 - low dose

CSL112 - high dose

Placebo

Arm Description

CSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.

CSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.

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.

Outcomes

Primary Outcome Measures

Percent of Participants With Clinically Important Change in Drug-induced Liver Injury

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.

Percent of Participants With Clinically Important Change in Renal Status

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

The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)

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.

Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants

Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for All Participants

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function

apoA-I and PC are analytes of CSL112

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function

apoA-I and PC are analytes of CSL112

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment

apoA-I and PC are analytes of CSL112

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment

apoA-I and PC are analytes of CSL112

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Cmax is the maximal plasma concentration.

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Tmax is time to maximal plasma concentration

Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants

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]

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants

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]

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function

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]

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

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]

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment

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]

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

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]

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

AUC from baseline to time point t (AUC0-t)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for All Participants

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for All Participants

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Change From Baseline in Plasma Terminal Half-life (t1/2) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for All Participants

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for All Participants

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Change From Baseline in Plasma Clearance (CL) for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Change From Baseline in Plasma Volume of Distribution at Steady State (Vss) for apoA-I and PC After First Infusion for All Participants

Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for All Participants

Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Change From Baseline in Plasma Vss for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Change From Baseline in Plasma Vss for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions

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.

Percent of Participants With Any Adverse Event (AE)

Percent of Participants Who Experience Bleeding Events

The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)

Change From Baseline in Serum Antibodies to CSL112 and apoA-I

Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19

Number of Participants With Parvovirus B19 DNA in Serum

Full Information

NCT ID

NCT02108262

First Posted

March 31, 2014

Last Updated

February 19, 2021

Sponsor

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT02108262

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSL Behring

4. Oversight

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1267 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSL112 - low dose

Arm Type

Experimental

Arm Description

CSL112 (low dose) is to be administered as an intravenous (IV) infusion once weekly for 4 consecutive weeks.

Arm Title

CSL112 - high dose

Arm Type

Experimental

Arm Description

CSL112 (high dose) is to be administered as an IV infusion once weekly for 4 consecutive weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

CSL112

Intervention Description

CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

0.9% weight/volume sodium chloride solution (ie, normal saline)

Primary Outcome Measure Information:

Title

Percent of Participants With Clinically Important Change in Drug-induced Liver Injury

Description

Time Frame

From baseline (before first infusion) to Day 29.

Title

Percent of Participants With Clinically Important Change in Renal Status

Description

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.

Time Frame

From baseline (before first infusion) to Day 29.

Secondary Outcome Measure Information:

Title

The Percentage of Participants With a Time-to-first Major Adverse Cardiovascular Event (MACE)

Description

Time Frame

From the start of the first infusion up to approximately 382 days

Title

Change From Baseline in Concentrations of Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) at End of First Infusion for All Participants

Description

Apolipoprotein A-I (apoA-I) and Phosphatidylcholine (PC) are analytes of CSL112

Time Frame

Before first infusion and end of first infusion

Title

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

Title

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Normal Renal Function

Description

apoA-I and PC are analytes of CSL112

Time Frame

Before first infusion and end of first infusion

Title

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Normal Renal Function

Description

apoA-I and PC are analytes of CSL112

Time Frame

Before first infusion and end of fourth infusion

Title

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of First Infusion for Participants With Mild Renal Impairment

Description

apoA-I and PC are analytes of CSL112

Time Frame

Before first infusion and end of first infusion

Title

Change From Baseline in Plasma Concentrations of apoA-I and PC at End of Fourth Infusion for Participants With Mild Renal Impairment

Description

apoA-I and PC are analytes of CSL112

Time Frame

Before first infusion and end of fourth infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for All Participants

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for All Participants

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma Cmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Description

Cmax is the maximal plasma concentration.

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for All Participants

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the first infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for All Participants

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the fourth infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the first infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the fourth infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the first infusion

Title

Change From Baseline in Plasma Tmax for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Description

Tmax is time to maximal plasma concentration

Time Frame

Before and for 7 days after the fourth infusion

Title

Change From Baseline in Plasma Area Under the Curve (AUC) AUC0 - Last for apoA-I and PC After First Infusion for All Participants

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for All Participants

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After First Infusion for Subjects With Mild Renal Impairment

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0 - Last for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Description

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]

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for All Participants

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for All Participants

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-t for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Description

AUC from baseline to time point t (AUC0-t)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for All Participants

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for All Participants

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Normal Renal Function

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Normal Renal Function

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After First Infusion for Participants With Mild Renal Impairment

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after first infusion

Title

Change From Baseline in Plasma AUC0-∞ for apoA-I and PC After Fourth Infusion for Participants With Mild Renal Impairment

Description

AUC0-∞ is plasma area under the curve (AUC0-infinity)

Time Frame

Before first infusion (baseline) and for up to approximately 7 days after fourth infusion

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Percent of Participants With the Occurrence of Suspected Adverse Drug Reactions

Description

Time Frame

From the start of first infusion, up to approximately Day 382

Title

Percent of Participants With Any Adverse Event (AE)

Time Frame

From the start of first infusion, up to approximately Day 382

Title

Percent of Participants Who Experience Bleeding Events

Description

The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)

Time Frame

From the start of first infusion, up to approximately Day 112

Title

Change From Baseline in Serum Antibodies to CSL112 and apoA-I

Time Frame

Before first infusion, up to approximately Day 112

Title

Number of Participants With Positive Serology Results for IgG and IgM Antibodies to Parvovirus B19

Time Frame

Study Day 112

Title

Number of Participants With Parvovirus B19 DNA in Serum

Time Frame

Study Day 112

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Denise D'Andrea

Organizational Affiliation

CSL Behring

Official's Role

Study Director

Facility Information:

Facility Name

Study Site 16101

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Study Site 16078

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Study Site - 16168

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Study Site 16168

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Study Site 16147

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

Facility Name

Study Site 16022

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Study Site 16130

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Study Site 16170

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06606

Country

United States

Facility Name

Study Site 16135

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Study Site 16148

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Study Site 16003

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Study Site 16144

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Study Site 16112

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

Study Site 16060

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Study Site 16179

City

Elkhart

State/Province

Indiana

ZIP/Postal Code

46514

Country

United States

Facility Name

Study Site 16102

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Study Site 16025

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Study Site 16088

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Study Site 16004

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Study Site 16016

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Study Site 16208

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Study Site 16062

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

Study Site 16079

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Study Site 16031

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Study Site 16028

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Study Site 16061

City

Petoskey

State/Province

Michigan

ZIP/Postal Code

49770

Country

United States

Facility Name

Study Site 16211

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Study Site 16234

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Study Site 16063

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Study Site 16033

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Study Site 16174

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Study Site 16213

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Study Site 16056

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Study Site 16201

City

Elizabeth City

State/Province

North Carolina

ZIP/Postal Code

27909

Country

United States

Facility Name

Study Site 16014

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Study Site 16024

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Study Site 16047

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Study Site 16026

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Study Site 16100

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17604

Country

United States

Facility Name

Study Site 16017

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Study Site 16039

City

Greenwood

State/Province

South Carolina

ZIP/Postal Code

29646

Country

United States

Facility Name

Study Site 16018

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Study Site 16202

City

Greeneville

State/Province

Tennessee

ZIP/Postal Code

37745

Country

United States

Facility Name

Study Site 16015

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Study Site 16099

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Study Site 16241

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76301

Country

United States

Facility Name

Study Site 16038

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Study Site 16166

City

Wausau

State/Province

Wisconsin

ZIP/Postal Code

54401

Country

United States

Facility Name

Study Site 10002

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Study Site 10005

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Study Site 10012

City

Woodville South

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

Study Site 10006

City

Epping

State/Province

Victoria

ZIP/Postal Code

3076

Country

Australia

Facility Name

Study Site 10007

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

Study Site 11004

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Study Site 11002

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Study Site 11001

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Study Site 12005

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

Study Site 12008

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Study Site 12006

City

Dobrich

ZIP/Postal Code

9300

Country

Bulgaria

Facility Name

Study Site 12021

City

Haskovo

ZIP/Postal Code

6300

Country

Bulgaria

Facility Name

Study Site 12009

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Study Site 12019

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Study Site 12016

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Study Site 12014

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Study Site 12018

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Study Site 12017

City

Sandanski

ZIP/Postal Code

2800

Country

Bulgaria

Facility Name

Study Site 12003

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Study Site 12001

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Study Site 12004

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Study Site 12012

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Study Site 12010

City

Sofia

ZIP/Postal Code

152

Country

Bulgaria

Facility Name

Study Site 12013

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

Study Site 12011

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Study Site 12002

City

Veliko Tarnovo

ZIP/Postal Code

5000

Country

Bulgaria

Facility Name

Study Site 12007

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Study Site - 13003

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5H 3V9

Country

Canada

Facility Name

Study Site - 13002

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Study Site - 13017

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A 3G6

Country

Canada

Facility Name

Study Site - 13012

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 4R2

Country

Canada

Facility Name

Study Site - 13019

City

St. Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Study Site - 13008

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Study Site - 13010

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P7

Country

Canada

Facility Name

Study Site - 13014

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Study Site - 13007

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Study Site 14010

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Study Site 14006

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Study Site 14004

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Study Site 14012

City

Jablonec nad Nisou

ZIP/Postal Code

466 60

Country

Czechia

Facility Name

Study Site 14011

City

Jihlava

ZIP/Postal Code

586 33

Country

Czechia

Facility Name

Study Site 14016

City

Kolin

ZIP/Postal Code

280 00

Country

Czechia

Facility Name

Study Site 14017

City

Nachod

ZIP/Postal Code

547 01

Country

Czechia

Facility Name

Study Site 14007

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Study Site 14003

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Study Site 14002

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Study Site 14001

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Study Site 14015

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Study Site 14008

City

Praha 4 - Krc

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Study Site 14009

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Study Site 14014

City

Teplice

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Study Site 14005

City

Usti nad Orlici

ZIP/Postal Code

562 18

Country

Czechia

Facility Name

Study Site 15001

City

Alborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Study Site 15005

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

Study Site 15002

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Study Site 15004

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Study Site 15003

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Study Site - 25003

City

Pessac

State/Province

Gironde

ZIP/Postal Code

33604

Country

France

Facility Name

Study Site - 25005

City

Toulouse cedex 3

State/Province

Haute Garonne

ZIP/Postal Code

31076

Country

France

Facility Name

Study Site - 25008

City

Nantes cedex

State/Province

Loire Antlantique

ZIP/Postal Code

44093

Country

France

Facility Name

Study Site - 25002

City

Paris cedex 12

State/Province

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Study Site - 25004

City

Pau

State/Province

Pyrenees Atlantiques

ZIP/Postal Code

64046

Country

France

Facility Name

Study Site - 25001

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Study Site 17001

City

Freiburg

State/Province

Baden Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Study Site 17005

City

Berlin

State/Province

Berin

ZIP/Postal Code

10249

Country

Germany

Facility Name

Study Site 17014

City

Franfurt

State/Province

Hessen

ZIP/Postal Code

65929

Country

Germany

Facility Name

Study Site 17012

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

Study Site 17007

City

Luedenscheid

State/Province

Nordrhein Westfalen

ZIP/Postal Code

58509

Country

Germany

Facility Name

Study Site 17010

City

Ludwigshafen

State/Province

Rheinland Pfalz

ZIP/Postal Code

67063

Country

Germany

Facility Name

Study Site 17011

City

Mainz

State/Province

Rheinland Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Study Site 17003

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Study Site 17009

City

Berlin

ZIP/Postal Code

10967

Country

Germany

Facility Name

Study Site 17002

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

Study Site 17006

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Study Site 18008

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Study Site 18001

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Study Site 18005

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Study Site 18002

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Study Site 18007

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Study Site 18003

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Study Site 18009

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Study Site 18006

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Study Site 19010

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Study Site 19006

City

Beer Sheva

ZIP/Postal Code

8410101

Country

Israel

Facility Name

Study Site 19005

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Study Site 19004

City

Holon

ZIP/Postal Code

5822012

Country

Israel

Facility Name

Study Site 19003

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Study Site 19007

City

Jerusalem

ZIP/Postal Code

9124001

Country

Israel

Facility Name

Study Site 19002

City

Nahariya

ZIP/Postal Code

2210001

Country

Israel

Facility Name

Study Site 19009

City

Ramat Gan

ZIP/Postal Code

5262000

Country

Israel

Facility Name

Study Site 19008

City

Safed

ZIP/Postal Code

13100

Country

Israel

Facility Name

Study Site 20003

City

Legnano

State/Province

Milano

ZIP/Postal Code

20025

Country

Italy

Facility Name

Study Site 20002

City

Magenta

State/Province

Milano

ZIP/Postal Code

20013

Country

Italy

Facility Name

Study Site 20008

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Study Site 20009

City

Benevento

ZIP/Postal Code

82100

Country

Italy

Facility Name

Study Site 20011

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Study Site 20007

City

Rimini

ZIP/Postal Code

47923

Country

Italy

Facility Name

Study Site 20012

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Study Site 20001

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Study Site 20006

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Study Site 21001

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Study Site 21006

City

Amsterdam

ZIP/Postal Code

091 AC

Country

Netherlands

Facility Name

Study Site 21013

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Study Site 21016

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Study Site 21004

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

Study Site 21014

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Study Site 21003

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Study Site 21008

City

Nijmegen

ZIP/Postal Code

6525 EC

Country

Netherlands

Facility Name

Study Site 21009

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

Study Site 21010

City

Sneek

ZIP/Postal Code

8601 ZK

Country

Netherlands

Facility Name

Study Site 21015

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

Study Site 21011

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Study Site - 22015

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Study Site - 22010

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Study Site - 22012

City

Inowroclaw

ZIP/Postal Code

88-10

Country

Poland

Facility Name

Study Site 22009

City

Kielce

ZIP/Postal Code

25-736

Country

Poland

Facility Name

Study Site - 22007

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

Study Site - 22014

City

Lodz

ZIP/Postal Code

91-347

Country

Poland

Facility Name

Study Site - 22013

City

Starogard Gdanski

ZIP/Postal Code

83-200

Country

Poland

Facility Name

Study Site - 22006

City

Walbrzych

ZIP/Postal Code

58-309

Country

Poland

Facility Name

Study Site - 22008

City

Warszawa

ZIP/Postal Code

01-211

Country

Poland

Facility Name

Study Site - 22016

City

Wejherowo

ZIP/Postal Code

84-200

Country

Poland

Facility Name

Study Site - 22005

City

Wroclaw

ZIP/Postal Code

50-981

Country

Poland

Facility Name

Study Site - 23010

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Study Site - 23012

City

A Coruna

State/Province

La Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Study Site - 23006

City

Santiago de Compostela

State/Province

La Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Study Site - 23005

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Study Site - 23002

City

Barcelona

ZIP/Postal Code

08023

Country

Spain

Facility Name

Study Site - 23001

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Study Site - 23003

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Study Site - 23013

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Study Site - 23004

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Study Site - 23007

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Study Site - 23009

City

Tarragona

ZIP/Postal Code

43007

Country

Spain

Facility Name

Study Site - 23011

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Study Site - 24006

City

Clydebank

State/Province

Dunbartonshire

ZIP/Postal Code

G81 1DY

Country

United Kingdom

Facility Name

Study Site - 24004

City

Basildon

State/Province

Essex

ZIP/Postal Code

SS16 5NL

Country

United Kingdom

Facility Name

Study Site 24005

City

Romford

State/Province

Essex

ZIP/Postal Code

UM7 0AG

Country

United Kingdom

Facility Name

Study Site - 24003

City

London

State/Province

Greater London

ZIP/Postal Code

E2 9JX

Country

United Kingdom

Facility Name

Study Site - 24010

City

Leicester

State/Province

Leicestershire

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

Study Site - 24009

City

Newcastle upon Tyne

State/Province

Tyne & Wear

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33217027

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.

Results Reference

derived

PubMed Identifier

27881559

Citation

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.

Results Reference

derived

PubMed Identifier

27659879

Citation

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.

Results Reference

derived

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

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

Acute Myocardial Infarction

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Arm 2

Arm 3

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