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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02108262




Registration number
NCT02108262
Ethics application status
Date submitted
31/03/2014
Date registered
9/04/2014
Date last updated
14/12/2016

Titles & IDs
Public title
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
Scientific 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.
Secondary ID [1] 0 0
2013-003458-26
Secondary ID [2] 0 0
CSLCT-HDL-12-77
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CSL112
Other interventions - Placebo

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

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

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.


Other interventions: 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.

Other interventions: Placebo
0.9% weight/volume sodium chloride solution (ie, normal saline)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From baseline (before 1st infusion) to Day 29.
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From baseline (before 1st infusion) to Day 29.
Secondary outcome [1] 0 0
The time-to-first occurrence of a major adverse cardiovascular event (MACE) - MACE includes: cardiovascular death, MI, ischemic stroke and hospitalization for unstable angina.
Timepoint [1] 0 0
From the start of the first infusion up to 112 days after infusion
Secondary outcome [2] 0 0
Pharmacokinetic profile of apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) - Baseline-corrected plasma apoA-I and PC concentrations
Timepoint [2] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [3] 0 0
Plasma apoA-I and PC Cmax
Timepoint [3] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [4] 0 0
Plasma apoA-I and PC Tmax
Timepoint [4] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [5] 0 0
Plasma apoA-I and PC area under the curve (AUC) - Baseline corrected plasma apoA-I and PC AUC0-infinity, AUC0 last
Timepoint [5] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [6] 0 0
Plasma apoA-I and PC t1/2
Timepoint [6] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [7] 0 0
Plasma apoA-I and PC Clearance
Timepoint [7] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [8] 0 0
Plasma apoA-I and PC Volume of distribution at steady state
Timepoint [8] 0 0
Before and for 7 days after the first and last infusions
Secondary outcome [9] 0 0
The occurrence of adverse reactions plus suspected adverse reactions (percentage of subjects) - 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.
Timepoint [9] 0 0
From the start of the infusion, up to approximately Day 112
Secondary outcome [10] 0 0
Overall AEs - The total number of subjects with any AE
Timepoint [10] 0 0
From the start of the infusion, up to approximately Day 382
Secondary outcome [11] 0 0
Bleeding events - The number of subjects who experience bleeding events as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al, 2011)
Timepoint [11] 0 0
From the start of the infusion, up to approximately Day 112
Secondary outcome [12] 0 0
Immunogenic potential of CSL112 - The number of subjects with serum antibodies to CSL112
Timepoint [12] 0 0
Before infusion, up to approximately Day 112
Secondary outcome [13] 0 0
Change from baseline in serology - Assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19
Timepoint [13] 0 0
Before infusion, up to approximately Day 112.
Secondary outcome [14] 0 0
Change from baseline in nucleic acid testing assessments - Assessments (i.e., evidence of seroconversion or infection) will be conducted for parvovirus B19
Timepoint [14] 0 0
Before infusion, up to approximately Day 112.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Study Site 10002 - Herston
Recruitment hospital [2] 0 0
Study Site 10005 - Adelaide
Recruitment hospital [3] 0 0
Study Site 10012 - Woodville South
Recruitment hospital [4] 0 0
Study Site 10006 - Epping
Recruitment hospital [5] 0 0
Study Site 10007 - Geelong
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment outside Australia
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United States of America
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Alabama
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT02108262
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Denise D'Andrea
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications