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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03473223




Registration number
NCT03473223
Ethics application status
Date submitted
14/03/2018
Date registered
22/03/2018

Titles & IDs
Public title
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Scientific title
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome
Secondary ID [1] 0 0
CSL112_3001
Universal Trial Number (UTN)
Trial acronym
AEGIS-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Apolipoprotein A-I [human] (apoA-I)
Other interventions - Placebo

Experimental: CSL112 - Apolipoprotein A-I \[human\]

Placebo comparator: Placebo - 25% albumin solution diluted to 4.4%


Treatment: Other: Apolipoprotein A-I [human] (apoA-I)
Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma for intravenous administration

Other interventions: Placebo
25% albumin solution diluted to 4.4%
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any component of composite MACE (CV death, MI, or stroke )
Timepoint [1] 0 0
Through 90 days
Secondary outcome [1] 0 0
Key secondary outcome: Total number of hospitalizations for coronary, cerebral, or peripheral ischemia
Timepoint [1] 0 0
Through 90 days
Secondary outcome [2] 0 0
Key secondary outcome: Time to first occurrence of CV death, MI, or stroke
Timepoint [2] 0 0
Through 180 days
Secondary outcome [3] 0 0
Key secondary outcome: Time to first occurrence of CV death, MI, or stroke
Timepoint [3] 0 0
Through 365 days
Secondary outcome [4] 0 0
Time to occurrence of CV death
Timepoint [4] 0 0
Through 90 days
Secondary outcome [5] 0 0
Time to first occurrence of MI
Timepoint [5] 0 0
Through 90 days
Secondary outcome [6] 0 0
Time to first occurrence of stroke
Timepoint [6] 0 0
Through 90 days
Secondary outcome [7] 0 0
Time to occurrence of all-cause death
Timepoint [7] 0 0
Through 365 days
Secondary outcome [8] 0 0
Number of subjects with adverse events
Timepoint [8] 0 0
Through 90 days
Secondary outcome [9] 0 0
Percent of subjects with adverse events
Timepoint [9] 0 0
Through 90 days
Secondary outcome [10] 0 0
Number of subjects with treatment-related adverse events
Timepoint [10] 0 0
Through 365 days
Secondary outcome [11] 0 0
Percent of subjects with treatment-related adverse events
Timepoint [11] 0 0
Through 365 days
Secondary outcome [12] 0 0
Number of subjects with serious adverse events
Timepoint [12] 0 0
Through 365 days
Secondary outcome [13] 0 0
Percent of subjects with serious adverse events
Timepoint [13] 0 0
Through 365 days
Secondary outcome [14] 0 0
Number of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low)
Timepoint [14] 0 0
Baseline and 29 days
Secondary outcome [15] 0 0
Percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low)
Timepoint [15] 0 0
Baseline and 29 days

Eligibility
Key inclusion criteria
* Male or female least 18 years of age
* Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
* No suspicion of acute kidney injury
* Evidence of multivessel coronary artery disease
* Presence of established cardiovascular risk factor(s):

1. Diabetes mellitus on pharmacotherapy OR
2. 2 or more of the following: age = 65 years, prior history of MI, peripheral arterial disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ongoing hemodynamic instability
* Evidence of hepatobiliary disease
* Evidence of severe chronic kidney disease
* Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
* Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

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 3
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
21/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2023
Sample size
Target
Accrual to date
Final
18200
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TazmaniaVIC,WA
Recruitment hospital [1] 0 0
0360087 - Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
0360069 - Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
0360070 - Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
0360071 - Wollongong Hospital - Wollongong
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0360063 - Cairns Base Hospital - Cairns
Recruitment hospital [6] 0 0
0360062 - The Prince Charles Hospital - Chermside
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0360061 - Royal Brisbane Hospital - Herston
Recruitment hospital [8] 0 0
0360060 - Gold Coast Hospital - Southport
Recruitment hospital [9] 0 0
0360057 - Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
0360032 - Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 0 0
0360055 - Queen Elizabeth Hospital - Woodville South
Recruitment hospital [12] 0 0
0360084 - Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
0360092 - Monash Medical Centre - Clayton
Recruitment hospital [14] 0 0
0360036 - The Northern Hospital - Epping
Recruitment hospital [15] 0 0
0360096 - Peninsula Health - Frankston
Recruitment hospital [16] 0 0
0360076 - Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
0360081 - Peninsula Heart Centre - Langwarrin
Recruitment hospital [18] 0 0
0360073 - The Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
0360080 - Fiona Stanley Hospital - Murdoch
Recruitment hospital [20] 0 0
0360059 - Royal Perth Hospital - Perth
Recruitment hospital [21] 0 0
0360072 - John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
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2170 - Liverpool
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2065 - St. Leonards
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2500 - Wollongong
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4870 - Cairns
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4032 - Chermside
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4029 - Herston
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4215 - Southport
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5000 - Adelaide
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5042 - Bedford Park
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5011 - Woodville South
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7001 - Hobart
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3168 - Clayton
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3076 - Epping
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3199 - Frankston
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3320 - Geelong
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3910 - Langwarrin
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3004 - Melbourne
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6150 - Murdoch
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6000 - Perth
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2305 - New Lambton Heights
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Bad Friedrichshall
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Frankfurt am Main
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Patra
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Piraeus
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Greece
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Kowloon
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Hong Kong
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Kwai Chung
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Hong Kong
State/province [224] 0 0
Sha Tin
Country [225] 0 0
Hungary
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Budapest
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Hungary
State/province [226] 0 0
Debrecen
Country [227] 0 0
Hungary
State/province [227] 0 0
Dombóvár
Country [228] 0 0
Hungary
State/province [228] 0 0
Gyula
Country [229] 0 0
Hungary
State/province [229] 0 0
Gyor
Country [230] 0 0
Hungary
State/province [230] 0 0
Kaposvár
Country [231] 0 0
Hungary
State/province [231] 0 0
Kecskemét
Country [232] 0 0
Hungary
State/province [232] 0 0
Nyíregyháza
Country [233] 0 0
Hungary
State/province [233] 0 0
Szeged
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Hungary
State/province [234] 0 0
Szekszárd
Country [235] 0 0
Hungary
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Szolnok
Country [236] 0 0
Hungary
State/province [236] 0 0
Székesfehérvár
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Hungary
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Zalaegerszeg
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Israel
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Afula
Country [239] 0 0
Israel
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Ashkelon
Country [240] 0 0
Israel
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Be'er Ya'aqov
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Israel
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Israel
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Kfar Saba
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Israel
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Israel
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Nazareth
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Israel
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Petah Tiqva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Safed
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Israel
State/province [252] 0 0
Tel Aviv-Yafo
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Busto Arsizio
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Italy
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Caserta
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Italy
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Catanzaro
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Italy
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Firenze
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Italy
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Milano
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Italy
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Napoli
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Italy
State/province [261] 0 0
Osio Sotto
Country [262] 0 0
Italy
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Palermo
Country [263] 0 0
Italy
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Pavia
Country [264] 0 0
Italy
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Roma
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Italy
State/province [265] 0 0
Rozzano
Country [266] 0 0
Japan
State/province [266] 0 0
Okayama
Country [267] 0 0
Japan
State/province [267] 0 0
Adachi-Ku
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Japan
State/province [268] 0 0
Amagasaki-Shi
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Japan
State/province [269] 0 0
Aoba-Ku
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Japan
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Asahi-Shi
Country [271] 0 0
Japan
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Fuchu-Shi
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Japan
State/province [272] 0 0
Fukuoka-Shi
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Japan
State/province [273] 0 0
Itabashi-Ku
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Japan
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Izunokuni-Shi
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Japan
State/province [275] 0 0
Kanazawa-Shi
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Japan
State/province [276] 0 0
Kasuga-Shi
Country [277] 0 0
Japan
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Kisarazu-Shi
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Japan
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Kochi-Shi
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Japan
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Kumamoto-Shi
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Poland
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Poland
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Poland
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Grodzisk Mazowiecki
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Poland
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Poland
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Poland
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Poland
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Poland
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Tychy
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Poland
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Poland
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Portugal
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Portugal
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Portugal
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Baia Mare
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Târgu-Mures
Country [420] 0 0
Russian Federation
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Arkhangel'sk
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Ivanovo
Country [424] 0 0
Russian Federation
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Kaluga
Country [425] 0 0
Russian Federation
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Kemerovo
Country [426] 0 0
Russian Federation
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Krasnoyarsk
Country [427] 0 0
Russian Federation
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Kursk
Country [428] 0 0
Russian Federation
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Lyubertsy
Country [429] 0 0
Russian Federation
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Moscow
Country [430] 0 0
Russian Federation
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Moskva
Country [431] 0 0
Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
Country [433] 0 0
Russian Federation
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Penza
Country [434] 0 0
Russian Federation
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Perm
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint Petersburg
Country [437] 0 0
Russian Federation
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Samara
Country [438] 0 0
Russian Federation
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Sankt-Peterburg
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Russian Federation
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Country [440] 0 0
Russian Federation
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Tomsk
Country [441] 0 0
Russian Federation
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Tula
Country [442] 0 0
Russian Federation
State/province [442] 0 0
Tyumen
Country [443] 0 0
Russian Federation
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Yaroslavl'
Country [444] 0 0
Russian Federation
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Serbia
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Savski Venac
Country [446] 0 0
Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
State/province [448] 0 0
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Serbia
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Niš
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Serbia
State/province [450] 0 0
Pancevo
Country [451] 0 0
Serbia
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Sremska Kamenica
Country [452] 0 0
Serbia
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Serbia
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Serbia
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Uzice
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Serbia
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Valjevo
Country [456] 0 0
Serbia
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Malacky
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Slovakia
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Nitra
Country [461] 0 0
Slovakia
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Rimavská Sobota
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Cape Town
Country [463] 0 0
South Africa
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Centurion
Country [464] 0 0
South Africa
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Johannesburg
Country [465] 0 0
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Sunninghill
Country [466] 0 0
South Africa
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Worcester
Country [467] 0 0
Spain
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Country [468] 0 0
Spain
State/province [468] 0 0
Alcorcón
Country [469] 0 0
Spain
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Country [470] 0 0
Spain
State/province [470] 0 0
Barcelona
Country [471] 0 0
Spain
State/province [471] 0 0
Huelva
Country [472] 0 0
Spain
State/province [472] 0 0
L'hospitalet de Llobregat
Country [473] 0 0
Spain
State/province [473] 0 0
Lleida
Country [474] 0 0
Spain
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Madrid
Country [475] 0 0
Spain
State/province [475] 0 0
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Country [476] 0 0
Spain
State/province [476] 0 0
Santander
Country [477] 0 0
Spain
State/province [477] 0 0
Tarragona
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Danielle Duffy, MD
Address 0 0
CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03473223