A Phase 2b study of CSL112 in subjects with acute myocardial infarction.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003458-26-DE

Enrollment

1200

Registered

2014-03-04

Start date

2014-07-15

Completion date

Unknown

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction MedDRA version: 19.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Code: CSL112 Pharmaceutical Form: Lyophilisate for solution for infusion INN or Proposed INN: ongoing CAS Number: 1361928-49-5 Current Sponsor code: CSL112 Other descriptive name: APOLIPOPROTE

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 780 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 420

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 (low dose [2 g] or high dose [6 g]) compared with placebo in subjects with acute myocardial infarction.;Secondary Objective: To examine the effect of CSL112 on the time-to-first occurrence of major adverse cardiovascular events (MACE), to characterize the safety and tolerability of CSL112, and to characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration.;Primary end point(s): - Clinically important change in drug-induced liver injury 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 as determined upon repeat measurement. - Clinically important change in renal status defined as a serum creatinine (Cr) increase to = 1.5 x the baseline value, that is confirmed as determined upon repeat measurement or the need for renal replacement therapy.;Timepoint(s) of evaluation of this end point: From baseline (before 1st infusion) to Day 29.	—

Measure

Time frame

Main Objective: To assess the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 (low dose [2 g] or high dose [6 g]) compared with placebo in subjects with acute myocardial infarction.;Secondary Objective: To examine the effect of CSL112 on the time-to-first occurrence of major adverse cardiovascular events (MACE), to characterize the safety and tolerability of CSL112, and to characterize the pharmacokinetics (PK) of CSL112 after multiple dose administration.;Primary end point(s): - Clinically important change in drug-induced liver injury 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 as determined upon repeat measurement. - Clinically important change in renal status defined as a serum creatinine (Cr) increase to = 1.5 x the baseline value, that is confirmed as determined upon repeat measurement or the need for renal replacement therapy.;Timepoint(s) of evaluation of this end point: From baseline (before 1st infusion) to Day 29.

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Secondary

Measure	Time frame
Secondary end point(s): 1. The time-to-first occurrence of a major adverse cardiovascular event (MACE). MACE includes: cardiovascular death, MI, ischemic stroke and hospitalization for unstable angina. 2. Pharmacokinetic profile (baseline-corrected plasma concentrations) of apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) 3. Plasma apoA-I and PC Cmax 4. Plasma apoA-I and PC Tmax 5. Plasma apoA-I and PC area under the curve (AUC) 6. Plasma apoA-I and PC t1/2 7. Plasma apoA-I and PC Clearance 8. Plasma apoA-I and PC Volume of distribution at steady state 9. The occurrence of adverse reactions or suspected adverse reactions: the overall number and 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 - with AEs for which the Investigator's causality assessment is mssing or indeterminate; 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. 10. Overall AEs: total number of subjects with any AE 11. Bleeding events: number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011) 12. Immunogenic potential of CSL112: number of subjects with serum antibodies to CSL112 13. Change from baseline in serology: assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19 14. Change from baseline in nucleic acid testing : assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19;Timepoint(s) of evaluation of this end point: 1. From the start of the first infusion up to 112 days after infusion 2.- 8.: Before and after the first and last infusions 9. From the start of the infusi	—

Measure

Time frame

Secondary end point(s): 1. The time-to-first occurrence of a major adverse cardiovascular event (MACE). MACE includes: cardiovascular death, MI, ischemic stroke and hospitalization for unstable angina. 2. Pharmacokinetic profile (baseline-corrected plasma concentrations) of apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) 3. Plasma apoA-I and PC Cmax 4. Plasma apoA-I and PC Tmax 5. Plasma apoA-I and PC area under the curve (AUC) 6. Plasma apoA-I and PC t1/2 7. Plasma apoA-I and PC Clearance 8. Plasma apoA-I and PC Volume of distribution at steady state 9. The occurrence of adverse reactions or suspected adverse reactions: the overall number and 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 - with AEs for which the Investigator's causality assessment is mssing or indeterminate; 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. 10. Overall AEs: total number of subjects with any AE 11. Bleeding events: number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011) 12. Immunogenic potential of CSL112: number of subjects with serum antibodies to CSL112 13. Change from baseline in serology: assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19 14. Change from baseline in nucleic acid testing : assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19;Timepoint(s) of evaluation of this end point: 1. From the start of the first infusion up to 112 days after infusion 2.- 8.: Before and after the first and last infusions 9. From the start of the infusi

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Countries

Australia, Austria, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClin.Trial Registration Coordinator

CSL Behring

clinicaltrials@cslbehring.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026