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

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ClinicalTrials.gov Identifier: NCT02108262
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Clinically important change in drug-induced liver injury [ Time Frame: From baseline (before 1st 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. Clinically important change in renal status [ Time Frame: From baseline (before 1st 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 time-to-first occurrence of a major adverse cardiovascular event (MACE) [ Time Frame: From the start of the first infusion up to 112 days after infusion ]
    MACE includes: cardiovascular death, MI, ischemic stroke and hospitalization for unstable angina.

  2. Pharmacokinetic profile of apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) [ Time Frame: Before and for 7 days after the first and last infusions ]
    Baseline-corrected plasma apoA-I and PC concentrations

  3. Plasma apoA-I and PC Cmax [ Time Frame: Before and for 7 days after the first and last infusions ]
  4. Plasma apoA-I and PC Tmax [ Time Frame: Before and for 7 days after the first and last infusions ]
  5. Plasma apoA-I and PC area under the curve (AUC) [ Time Frame: Before and for 7 days after the first and last infusions ]
    Baseline corrected plasma apoA-I and PC AUC0-infinity, AUC0 last

  6. Plasma apoA-I and PC t1/2 [ Time Frame: Before and for 7 days after the first and last infusions ]
  7. Plasma apoA-I and PC Clearance [ Time Frame: Before and for 7 days after the first and last infusions ]
  8. Plasma apoA-I and PC Volume of distribution at steady state [ Time Frame: Before and for 7 days after the first and last infusions ]
  9. The occurrence of adverse reactions plus suspected adverse reactions (percentage of subjects) [ Time Frame: From the start of the infusion, up to approximately Day 112 ]

    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.

  10. Overall AEs [ Time Frame: From the start of the infusion, up to approximately Day 382 ]
    The total number of subjects with any AE

  11. Bleeding events [ Time Frame: From the start of the 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)

  12. Immunogenic potential of CSL112 [ Time Frame: Before infusion, up to approximately Day 112 ]
    The number of subjects with serum antibodies to CSL112

  13. Change from baseline in serology [ Time Frame: Before infusion, up to approximately Day 112. ]
    Assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19

  14. Change from baseline in nucleic acid testing assessments [ Time Frame: Before infusion, up to approximately Day 112. ]
    Assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19


Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108262


Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Dr. Denise D'Andrea CSL Behring
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases