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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05754957




Registration number
NCT05754957
Ethics application status
Date submitted
23/02/2023
Date registered
6/03/2023

Titles & IDs
Public title
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
70033093ACS3003
Secondary ID [2] 0 0
CR109271
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-ACS
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: Drugs - Milvexian
Other interventions - Placebo

Experimental: Milvexian - Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy \[SAPT\] or dual antiplatelet therapy \[DAPT\]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.

Placebo comparator: Placebo - Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Other interventions: Placebo
Placebo will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [1] 0 0
Time to the First Occurrence of Major Adverse Vascular Event (MAVE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [2] 0 0
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
Timepoint [2] 0 0
Up to 3 years 6 months
Secondary outcome [3] 0 0
Time to Cardiovascular (CV) Death
Timepoint [3] 0 0
Up to 3 years 6 months
Secondary outcome [4] 0 0
Time to All-cause Mortality (ACM)
Timepoint [4] 0 0
Up to 3 years 6 months

Eligibility
Key inclusion criteria
* Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory
* Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention [PCI] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)
* All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
* A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
* Planned CABG or staged PCI after randomization
* Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
* Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Study design
Purpose of the study
Treatment
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/10/2026
Actual
Sample size
Target
16000
Accrual to date
Final
Recruitment in Australia
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Flinders Medical Centre - Adelaide
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Ballarat Base Hospital - Ballarat
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Sunshine Coast University Hospital - Birtinya
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Cairns Base Hospital - Cairns
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Royal Brisbane and Women's Hospital - Herston
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Royal Hobart Hospital - Hobart
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Nepean Hospital - Kingswood
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Core Research Group - Milton
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Fiona Stanley Hospital - Murdoch
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Westmead Hospital - Sydney
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5042 - Adelaide
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3350 - Ballarat
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4575 - Birtinya
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4870 - Cairns
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2050 - Camperdown
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2139 - Concord
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4029 - Herston
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7000 - Hobart
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2747 - Kingswood
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4064 - Milton
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6150 - Murdoch
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2145 - Sydney
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Toulouse Cedex 9
Country [210] 0 0
France
State/province [210] 0 0
Vandoeuvre les Nancy Cedex
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France
State/province [211] 0 0
Versailles Cedex
Country [212] 0 0
Germany
State/province [212] 0 0
Bad Friedrichshall
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Germany
State/province [213] 0 0
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Germany
State/province [214] 0 0
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Germany
State/province [215] 0 0
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Germany
State/province [216] 0 0
Bielefeld
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Germany
State/province [217] 0 0
Bitburg
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Germany
State/province [218] 0 0
Bonn-Beuel
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Germany
State/province [219] 0 0
Bonn
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Germany
State/province [220] 0 0
Brandenburg an der Havel
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Germany
State/province [221] 0 0
Dortmund
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Germany
State/province [222] 0 0
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Germany
State/province [223] 0 0
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Germany
State/province [224] 0 0
Greifswald
Country [225] 0 0
Germany
State/province [225] 0 0
Hamburg
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Germany
State/province [226] 0 0
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Germany
State/province [227] 0 0
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Germany
State/province [228] 0 0
Luedenscheid
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Germany
State/province [229] 0 0
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Germany
State/province [230] 0 0
Mannheim
Country [231] 0 0
Germany
State/province [231] 0 0
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Germany
State/province [232] 0 0
Neuwied
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Germany
State/province [233] 0 0
Remscheid
Country [234] 0 0
Germany
State/province [234] 0 0
Rostock
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Germany
State/province [235] 0 0
Worms
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Greece
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Greece
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Greece
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Patra
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Greece
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Country [243] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvar
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Hungary
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Kecskemet
Country [247] 0 0
Hungary
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Pecs
Country [248] 0 0
Hungary
State/province [248] 0 0
Szeged
Country [249] 0 0
Hungary
State/province [249] 0 0
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Hungary
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Szolnok
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Hungary
State/province [251] 0 0
Szombathely
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Hungary
State/province [252] 0 0
Zalaegerszeg
Country [253] 0 0
India
State/province [253] 0 0
Bangalore
Country [254] 0 0
India
State/province [254] 0 0
Belgaum
Country [255] 0 0
India
State/province [255] 0 0
Chennai
Country [256] 0 0
India
State/province [256] 0 0
Cochin
Country [257] 0 0
India
State/province [257] 0 0
Delhi
Country [258] 0 0
India
State/province [258] 0 0
Hyderabad
Country [259] 0 0
India
State/province [259] 0 0
Hyderbad
Country [260] 0 0
India
State/province [260] 0 0
Kolkata
Country [261] 0 0
India
State/province [261] 0 0
Ludhiana
Country [262] 0 0
India
State/province [262] 0 0
Mangalore
Country [263] 0 0
India
State/province [263] 0 0
Nagpur
Country [264] 0 0
India
State/province [264] 0 0
New Delhi
Country [265] 0 0
India
State/province [265] 0 0
Pune
Country [266] 0 0
India
State/province [266] 0 0
Shimoga
Country [267] 0 0
India
State/province [267] 0 0
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Country [268] 0 0
Israel
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Israel
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Ashdod
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Israel
State/province [270] 0 0
Ashkelon
Country [271] 0 0
Israel
State/province [271] 0 0
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Country [272] 0 0
Israel
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Israel
State/province [273] 0 0
Holon
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Israel
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Jerusalem
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Israel
State/province [275] 0 0
Kfar-Sava
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Israel
State/province [276] 0 0
Naharya
Country [277] 0 0
Israel
State/province [277] 0 0
Petah Tikva
Country [278] 0 0
Israel
State/province [278] 0 0
Ramat Gan
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Israel
State/province [279] 0 0
Rechovot
Country [280] 0 0
Israel
State/province [280] 0 0
Rishon Lezion
Country [281] 0 0
Israel
State/province [281] 0 0
Safed
Country [282] 0 0
Israel
State/province [282] 0 0
Tiberias
Country [283] 0 0
Italy
State/province [283] 0 0
Alessandria
Country [284] 0 0
Italy
State/province [284] 0 0
Bergamo
Country [285] 0 0
Italy
State/province [285] 0 0
Bologna
Country [286] 0 0
Italy
State/province [286] 0 0
Chieti
Country [287] 0 0
Italy
State/province [287] 0 0
La Spezia
Country [288] 0 0
Italy
State/province [288] 0 0
Mestre
Country [289] 0 0
Italy
State/province [289] 0 0
Milano
Country [290] 0 0
Italy
State/province [290] 0 0
Napoli
Country [291] 0 0
Italy
State/province [291] 0 0
Parma
Country [292] 0 0
Italy
State/province [292] 0 0
Pavia
Country [293] 0 0
Italy
State/province [293] 0 0
Pisa
Country [294] 0 0
Italy
State/province [294] 0 0
Roma
Country [295] 0 0
Italy
State/province [295] 0 0
Rozzano
Country [296] 0 0
Italy
State/province [296] 0 0
Sassari
Country [297] 0 0
Italy
State/province [297] 0 0
Seriate
Country [298] 0 0
Italy
State/province [298] 0 0
Sesto San Giovanni
Country [299] 0 0
Italy
State/province [299] 0 0
Torrette Di Ancona
Country [300] 0 0
Italy
State/province [300] 0 0
Treviglio
Country [301] 0 0
Japan
State/province [301] 0 0
Aichi
Country [302] 0 0
Japan
State/province [302] 0 0
Amagasaki shi
Country [303] 0 0
Japan
State/province [303] 0 0
Chiba
Country [304] 0 0
Japan
State/province [304] 0 0
Chikushino-shi
Country [305] 0 0
Japan
State/province [305] 0 0
Fukui-shi
Country [306] 0 0
Japan
State/province [306] 0 0
Fukuoka-shi
Country [307] 0 0
Japan
State/province [307] 0 0
Fukuoka
Country [308] 0 0
Japan
State/province [308] 0 0
Gifu
Country [309] 0 0
Japan
State/province [309] 0 0
Gunma
Country [310] 0 0
Japan
State/province [310] 0 0
Himeji-shi
Country [311] 0 0
Japan
State/province [311] 0 0
Hiratsuka-shi
Country [312] 0 0
Japan
State/province [312] 0 0
Hirosaki
Country [313] 0 0
Japan
State/province [313] 0 0
Hiroshima
Country [314] 0 0
Japan
State/province [314] 0 0
Isehara
Country [315] 0 0
Japan
State/province [315] 0 0
Ishikawa
Country [316] 0 0
Japan
State/province [316] 0 0
Itabashi Ku
Country [317] 0 0
Japan
State/province [317] 0 0
Izunokuni-shi
Country [318] 0 0
Japan
State/province [318] 0 0
Kamogawa
Country [319] 0 0
Japan
State/province [319] 0 0
Kanagawa
Country [320] 0 0
Japan
State/province [320] 0 0
Kanazawa-shi
Country [321] 0 0
Japan
State/province [321] 0 0
Kasuga-shi
Country [322] 0 0
Japan
State/province [322] 0 0
Kisarazu-shi
Country [323] 0 0
Japan
State/province [323] 0 0
Kitakyushu-shi
Country [324] 0 0
Japan
State/province [324] 0 0
Kochi
Country [325] 0 0
Japan
State/province [325] 0 0
Koga
Country [326] 0 0
Japan
State/province [326] 0 0
Kumamoto-shi
Country [327] 0 0
Japan
State/province [327] 0 0
Kurashiki
Country [328] 0 0
Japan
State/province [328] 0 0
Kure-shi
Country [329] 0 0
Japan
State/province [329] 0 0
Kyoto-shi
Country [330] 0 0
Japan
State/province [330] 0 0
Kyoto
Country [331] 0 0
Japan
State/province [331] 0 0
Matsudo-shi
Country [332] 0 0
Japan
State/province [332] 0 0
Matsumoto-shi
Country [333] 0 0
Japan
State/province [333] 0 0
Meguro-ku
Country [334] 0 0
Japan
State/province [334] 0 0
Minato-ku
Country [335] 0 0
Japan
State/province [335] 0 0
Miyazaki-shi
Country [336] 0 0
Japan
State/province [336] 0 0
Nagoya-shi
Country [337] 0 0
Japan
State/province [337] 0 0
Nishinomiya-shi
Country [338] 0 0
Japan
State/province [338] 0 0
Okayama shi
Country [339] 0 0
Japan
State/province [339] 0 0
Osaka-shi
Country [340] 0 0
Japan
State/province [340] 0 0
Osaka
Country [341] 0 0
Japan
State/province [341] 0 0
Sagamihara
Country [342] 0 0
Japan
State/province [342] 0 0
Saga
Country [343] 0 0
Japan
State/province [343] 0 0
Saitama-shi
Country [344] 0 0
Japan
State/province [344] 0 0
Saitama
Country [345] 0 0
Japan
State/province [345] 0 0
Sendai
Country [346] 0 0
Japan
State/province [346] 0 0
Shinagawa
Country [347] 0 0
Japan
State/province [347] 0 0
Shinjuku-ku
Country [348] 0 0
Japan
State/province [348] 0 0
Shiwa-gun
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Japan
State/province [349] 0 0
Suita-Shi
Country [350] 0 0
Japan
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Takamatsu
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Japan
State/province [351] 0 0
Tokushima
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Japan
State/province [352] 0 0
Tokyo
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Japan
State/province [353] 0 0
Toyama-shi
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Japan
State/province [354] 0 0
Tsuchiura-City
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Japan
State/province [355] 0 0
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Japan
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Tsu
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Japan
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Ube
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Japan
State/province [358] 0 0
Urayasu-shi
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Japan
State/province [359] 0 0
Ureshino-shi
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Japan
State/province [360] 0 0
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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
State/province [365] 0 0
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Korea, Republic of
State/province [366] 0 0
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Korea, Republic of
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Korea, Republic of
State/province [368] 0 0
Gangseo-gu
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Korea, Republic of
State/province [369] 0 0
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Korea, Republic of
State/province [370] 0 0
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Country [371] 0 0
Korea, Republic of
State/province [371] 0 0
Gyeonggi Do
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Korea, Republic of
State/province [372] 0 0
Incheon
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Korea, Republic of
State/province [373] 0 0
Sejong-si
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Korea, Republic of
State/province [374] 0 0
Seoul
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Korea, Republic of
State/province [375] 0 0
Wonju
Country [376] 0 0
Korea, Republic of
State/province [376] 0 0
Yangsan Si
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Daugavpils
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Riga
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Malaysia
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Kota Bahru
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Malaysia
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Kota Bharu
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Malaysia
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
Country [387] 0 0
Malaysia
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Miri
Country [388] 0 0
Malaysia
State/province [388] 0 0
Seberang Jaya
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Malaysia
State/province [389] 0 0
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Mexico
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Mexico
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Culiacan
Country [392] 0 0
Mexico
State/province [392] 0 0
Mazatlan
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Mexico
State/province [393] 0 0
Monterrey
Country [394] 0 0
Mexico
State/province [394] 0 0
Queretaro
Country [395] 0 0
Mexico
State/province [395] 0 0
San Luis Potosí
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Mexico
State/province [396] 0 0
Tijuana
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Mexico
State/province [397] 0 0
Torreon
Country [398] 0 0
Netherlands
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Netherlands
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Almelo
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Netherlands
State/province [400] 0 0
Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Deventer
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Netherlands
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Ede
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Netherlands
State/province [404] 0 0
Eindhoven
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Netherlands
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Emmen
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Netherlands
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Enschede
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Netherlands
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Netherlands
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Gouda
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Netherlands
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Harderwijk
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Netherlands
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Heerlen
Country [411] 0 0
Netherlands
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Helmond
Country [412] 0 0
Netherlands
State/province [412] 0 0
Leiderdorp
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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Netherlands
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Nijmegen
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Netherlands
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Netherlands
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Rotterdam
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Netherlands
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s-Hertogenbosch
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Netherlands
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Sneek
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Netherlands
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Tiel
Country [421] 0 0
Netherlands
State/province [421] 0 0
Utrecht
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Netherlands
State/province [422] 0 0
Veldhoven
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Netherlands
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Netherlands
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Zutphen
Country [425] 0 0
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New Zealand
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Christchurch
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New Zealand
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Country [428] 0 0
New Zealand
State/province [428] 0 0
Hastings
Country [429] 0 0
New Zealand
State/province [429] 0 0
New Plymouth
Country [430] 0 0
New Zealand
State/province [430] 0 0
Otahuhu
Country [431] 0 0
New Zealand
State/province [431] 0 0
Rotorua
Country [432] 0 0
New Zealand
State/province [432] 0 0
Tauranga
Country [433] 0 0
New Zealand
State/province [433] 0 0
Whangarei
Country [434] 0 0
Philippines
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Angeles
Country [435] 0 0
Philippines
State/province [435] 0 0
Davao City, Davao Del Sur
Country [436] 0 0
Philippines
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Davao
Country [437] 0 0
Philippines
State/province [437] 0 0
Lipa City
Country [438] 0 0
Poland
State/province [438] 0 0
Bialystok
Country [439] 0 0
Poland
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Bydgoszcz
Country [440] 0 0
Poland
State/province [440] 0 0
Bytom
Country [441] 0 0
Poland
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Elblag
Country [442] 0 0
Poland
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Katowice
Country [443] 0 0
Poland
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Kielce
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Poland
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Krakow
Country [445] 0 0
Poland
State/province [445] 0 0
Lodz
Country [446] 0 0
Poland
State/province [446] 0 0
Lublin
Country [447] 0 0
Poland
State/province [447] 0 0
Naleczow
Country [448] 0 0
Poland
State/province [448] 0 0
Olsztyn
Country [449] 0 0
Poland
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Oswiecim
Country [450] 0 0
Poland
State/province [450] 0 0
Przemysl
Country [451] 0 0
Poland
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Siedlce
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Poland
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Skierniewice
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Poland
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Sopot
Country [454] 0 0
Poland
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Torun
Country [455] 0 0
Poland
State/province [455] 0 0
Warszawa
Country [456] 0 0
Poland
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Walbrzych
Country [457] 0 0
Poland
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Wroclaw
Country [458] 0 0
Portugal
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Aveiro
Country [459] 0 0
Portugal
State/province [459] 0 0
Braga
Country [460] 0 0
Portugal
State/province [460] 0 0
Covilha
Country [461] 0 0
Portugal
State/province [461] 0 0
Guimaraes
Country [462] 0 0
Portugal
State/province [462] 0 0
Leiria
Country [463] 0 0
Portugal
State/province [463] 0 0
Lisboa
Country [464] 0 0
Portugal
State/province [464] 0 0
Lisbon
Country [465] 0 0
Portugal
State/province [465] 0 0
Santa Maria da Feira
Country [466] 0 0
Portugal
State/province [466] 0 0
Vila Nova de Gaia
Country [467] 0 0
Portugal
State/province [467] 0 0
Vila Real
Country [468] 0 0
Romania
State/province [468] 0 0
Baia-Mare
Country [469] 0 0
Romania
State/province [469] 0 0
Brasov
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Romania
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Bucharest
Country [471] 0 0
Romania
State/province [471] 0 0
Bucuresti
Country [472] 0 0
Romania
State/province [472] 0 0
Cluj-Napoca
Country [473] 0 0
Romania
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Constanta
Country [474] 0 0
Romania
State/province [474] 0 0
Craiova
Country [475] 0 0
Romania
State/province [475] 0 0
Iasi
Country [476] 0 0
Romania
State/province [476] 0 0
Oradea
Country [477] 0 0
Romania
State/province [477] 0 0
Pitesti
Country [478] 0 0
Romania
State/province [478] 0 0
Targu-Mures
Country [479] 0 0
Romania
State/province [479] 0 0
Tg. Mures
Country [480] 0 0
Romania
State/province [480] 0 0
Timisoara
Country [481] 0 0
Serbia
State/province [481] 0 0
Belgrade
Country [482] 0 0
Serbia
State/province [482] 0 0
Kragujevac
Country [483] 0 0
Serbia
State/province [483] 0 0
Niska Banja
Country [484] 0 0
Serbia
State/province [484] 0 0
Nis
Country [485] 0 0
Serbia
State/province [485] 0 0
Pancevo
Country [486] 0 0
Serbia
State/province [486] 0 0
Smederevo
Country [487] 0 0
Serbia
State/province [487] 0 0
Sremska Mitrovica
Country [488] 0 0
Serbia
State/province [488] 0 0
Zajecar
Country [489] 0 0
Slovakia
State/province [489] 0 0
Banska Bystrica
Country [490] 0 0
Slovakia
State/province [490] 0 0
Bardejov
Country [491] 0 0
Slovakia
State/province [491] 0 0
Bratislava
Country [492] 0 0
Slovakia
State/province [492] 0 0
Brezno
Country [493] 0 0
Slovakia
State/province [493] 0 0
Kosice
Country [494] 0 0
Slovakia
State/province [494] 0 0
Košice
Country [495] 0 0
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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/NCT05754957