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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05702034




Registration number
NCT05702034
Ethics application status
Date submitted
19/01/2023
Date registered
27/01/2023

Titles & IDs
Public title
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
Scientific title
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Secondary ID [1] 0 0
70033093STR3001
Secondary ID [2] 0 0
CR109231
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-STROK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke; Ischemic Attack, Transient 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Milvexian
Treatment: Drugs - Placebo

Experimental: Milvexian - Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT \[single antiplatelet therapy\] or DAPT \[dual antiplatelet therapy\]) will receive milvexian 25 milligrams (mg), orally, twice daily.

Placebo comparator: Placebo - Participants after an acute ischemic stroke or high-risk TIA who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) will receive placebo orally twice daily.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

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

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Ischemic Stroke
Timepoint [1] 0 0
Up to global targeted endpoint date (approximately 41 months)
Secondary outcome [1] 0 0
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke
Timepoint [1] 0 0
Up to global targeted endpoint date (approximately 41 months)
Secondary outcome [2] 0 0
Time to First Occurrence of Ischemic Stroke
Timepoint [2] 0 0
Up to Day 90
Secondary outcome [3] 0 0
Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE)
Timepoint [3] 0 0
Up to global targeted endpoint date (approximately 41 months)

Eligibility
Key inclusion criteria
* Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and national institute of health stroke score scale (NIHSS) score less than or equal to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the ischemic event at the time of randomization, or acute, ischemic brain lesion determined by standard-of-care neuroimaging, or participant underwent thrombolysis or thrombectomy, or transient ischemic attack (TIA): acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (example, computed tomography (CT) scan or magnetic resonance imaging (MRI), performed as part of standard medical practice), and ABCD2 Score greater than or equal to (>=) 6
* Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event.
* Current or planned antiplatelet treatment per international and/or local guidelines. If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100 milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
* A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half lives) after the last dose of study intervention
* Willing and able to adhere to the lifestyle restrictions specified in this protocol
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than (>) 1 year prior with adequate treatment
* The index stroke or TIA is considered to have a cardio-embolic etiology based on local standard-of-care investigations and for which guidelines recommend anticoagulation
* The index stroke or TIA considered to have another known cause, not related to athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined Etiology), based on local standard-of-care investigations
* Increased risk of bleeding, including clinically significant bleeding within the previous 3 months or known bleeding diathesis or known activated partial thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal hemorrhage
* Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants receiving antiviral treatment for hepatitis
* Known allergies, hypersensitivity, or intolerance to milvexian or its excipients

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
15/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/12/2026
Actual
Sample size
Target
15000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
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Box Hill Hospital - Box Hill
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Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
St Vincent's Hospital - Melbourne - Fitzroy
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Austin Health - Heidelberg
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Royal Brisbane and Women's Hospital - Herston
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Launceston General Hospital - Launceston
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Liverpool Hospital - Liverpool
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Fiona Stanley Hospital - Murdoch
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Royal Melbourne Hospital - Parkville
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Prince Of Wales Hospital - Randwick
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Mater Hospital Brisbane - South Brisbane
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Gold Coast University Hospital - Southport
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Latrobe Regional Hospital - Traralgon
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Princess Alexandra Hospital - Woolloongabba
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5000 - Adelaide
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5042 - Adelaide
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3128 - Box Hill
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2050 - Camperdown
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4102 - Woolloongabba
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State/province [201] 0 0
Berlin
Country [202] 0 0
Germany
State/province [202] 0 0
Dortmund
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Germany
State/province [203] 0 0
Dresden
Country [204] 0 0
Germany
State/province [204] 0 0
Erlangen
Country [205] 0 0
Germany
State/province [205] 0 0
Essen
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Germany
State/province [206] 0 0
Frankfurt
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Germany
State/province [207] 0 0
Friedrichshafen
Country [208] 0 0
Germany
State/province [208] 0 0
Fulda
Country [209] 0 0
Germany
State/province [209] 0 0
Giessen
Country [210] 0 0
Germany
State/province [210] 0 0
Goettingen
Country [211] 0 0
Germany
State/province [211] 0 0
Hamburg
Country [212] 0 0
Germany
State/province [212] 0 0
Leipzig
Country [213] 0 0
Germany
State/province [213] 0 0
Lohr am Main
Country [214] 0 0
Germany
State/province [214] 0 0
Luebeck
Country [215] 0 0
Germany
State/province [215] 0 0
Lueneburg
Country [216] 0 0
Germany
State/province [216] 0 0
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Country [217] 0 0
Germany
State/province [217] 0 0
Muenchen
Country [218] 0 0
Germany
State/province [218] 0 0
Muenster
Country [219] 0 0
Germany
State/province [219] 0 0
Potsdam
Country [220] 0 0
Germany
State/province [220] 0 0
Sande
Country [221] 0 0
Germany
State/province [221] 0 0
Schleswig
Country [222] 0 0
Germany
State/province [222] 0 0
Tuebingen
Country [223] 0 0
Germany
State/province [223] 0 0
Ulm
Country [224] 0 0
Germany
State/province [224] 0 0
Wuerzburg
Country [225] 0 0
Greece
State/province [225] 0 0
Alexandroupolis
Country [226] 0 0
Greece
State/province [226] 0 0
Athens
Country [227] 0 0
Greece
State/province [227] 0 0
Ioannina
Country [228] 0 0
Greece
State/province [228] 0 0
Larisa
Country [229] 0 0
Greece
State/province [229] 0 0
Larissa
Country [230] 0 0
Greece
State/province [230] 0 0
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Country [231] 0 0
Hong Kong
State/province [231] 0 0
Hong Kong
Country [232] 0 0
Hong Kong
State/province [232] 0 0
N T
Country [233] 0 0
Hong Kong
State/province [233] 0 0
New Territories
Country [234] 0 0
Hungary
State/province [234] 0 0
Budapest
Country [235] 0 0
Hungary
State/province [235] 0 0
Debrecen
Country [236] 0 0
Hungary
State/province [236] 0 0
Dunaujvaros
Country [237] 0 0
Hungary
State/province [237] 0 0
Eger
Country [238] 0 0
Hungary
State/province [238] 0 0
Kistarcsa
Country [239] 0 0
Hungary
State/province [239] 0 0
Kisvarda
Country [240] 0 0
Hungary
State/province [240] 0 0
Miskolc
Country [241] 0 0
Hungary
State/province [241] 0 0
Salgotarjan
Country [242] 0 0
Hungary
State/province [242] 0 0
Tatabanya
Country [243] 0 0
Hungary
State/province [243] 0 0
Vac
Country [244] 0 0
India
State/province [244] 0 0
Ahmedabad
Country [245] 0 0
India
State/province [245] 0 0
Ajmer
Country [246] 0 0
India
State/province [246] 0 0
Anand
Country [247] 0 0
India
State/province [247] 0 0
Bangalore
Country [248] 0 0
India
State/province [248] 0 0
Belgaum
Country [249] 0 0
India
State/province [249] 0 0
Bhubaneswar
Country [250] 0 0
India
State/province [250] 0 0
Bikaner
Country [251] 0 0
India
State/province [251] 0 0
Chennai
Country [252] 0 0
India
State/province [252] 0 0
Coimbatore
Country [253] 0 0
India
State/province [253] 0 0
Faridkot
Country [254] 0 0
India
State/province [254] 0 0
Gurgaon
Country [255] 0 0
India
State/province [255] 0 0
Guwahati
Country [256] 0 0
India
State/province [256] 0 0
Hyderabad
Country [257] 0 0
India
State/province [257] 0 0
Hyderbad
Country [258] 0 0
India
State/province [258] 0 0
Jaipur
Country [259] 0 0
India
State/province [259] 0 0
Kolkata
Country [260] 0 0
India
State/province [260] 0 0
Kozhikode
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
Mumbai
Country [264] 0 0
India
State/province [264] 0 0
Mysuru
Country [265] 0 0
India
State/province [265] 0 0
Nashik
Country [266] 0 0
India
State/province [266] 0 0
New Delhi
Country [267] 0 0
India
State/province [267] 0 0
Pune
Country [268] 0 0
India
State/province [268] 0 0
Rajkot
Country [269] 0 0
India
State/province [269] 0 0
Sumthana
Country [270] 0 0
India
State/province [270] 0 0
Surat
Country [271] 0 0
India
State/province [271] 0 0
Thane
Country [272] 0 0
India
State/province [272] 0 0
Thiruvananthapuram
Country [273] 0 0
India
State/province [273] 0 0
Varanasi
Country [274] 0 0
India
State/province [274] 0 0
Vellore
Country [275] 0 0
India
State/province [275] 0 0
Vijayawada
Country [276] 0 0
India
State/province [276] 0 0
Visakhapatnam
Country [277] 0 0
India
State/province [277] 0 0
Vishakhapatnam
Country [278] 0 0
India
State/province [278] 0 0
Vizianagaram
Country [279] 0 0
India
State/province [279] 0 0
Warangal
Country [280] 0 0
Israel
State/province [280] 0 0
Beer sheva
Country [281] 0 0
Israel
State/province [281] 0 0
Haifa
Country [282] 0 0
Israel
State/province [282] 0 0
Jerusalem
Country [283] 0 0
Israel
State/province [283] 0 0
Naharya
Country [284] 0 0
Israel
State/province [284] 0 0
Petah Tikva
Country [285] 0 0
Israel
State/province [285] 0 0
Ramat Gan
Country [286] 0 0
Israel
State/province [286] 0 0
Safed
Country [287] 0 0
Israel
State/province [287] 0 0
Tel Aviv
Country [288] 0 0
Italy
State/province [288] 0 0
Brescia
Country [289] 0 0
Italy
State/province [289] 0 0
Cremona
Country [290] 0 0
Italy
State/province [290] 0 0
Foligno
Country [291] 0 0
Italy
State/province [291] 0 0
Genova
Country [292] 0 0
Italy
State/province [292] 0 0
Gubbio
Country [293] 0 0
Italy
State/province [293] 0 0
L'Aquila
Country [294] 0 0
Italy
State/province [294] 0 0
Lecce
Country [295] 0 0
Italy
State/province [295] 0 0
Lecco
Country [296] 0 0
Italy
State/province [296] 0 0
Massa
Country [297] 0 0
Italy
State/province [297] 0 0
Milano
Country [298] 0 0
Italy
State/province [298] 0 0
Modena
Country [299] 0 0
Italy
State/province [299] 0 0
Pavia
Country [300] 0 0
Italy
State/province [300] 0 0
Perugia
Country [301] 0 0
Italy
State/province [301] 0 0
Pietra Ligure
Country [302] 0 0
Italy
State/province [302] 0 0
Pisa
Country [303] 0 0
Italy
State/province [303] 0 0
Reggio Emilia
Country [304] 0 0
Italy
State/province [304] 0 0
Roma
Country [305] 0 0
Italy
State/province [305] 0 0
Trieste
Country [306] 0 0
Italy
State/province [306] 0 0
Udine
Country [307] 0 0
Italy
State/province [307] 0 0
Verona
Country [308] 0 0
Japan
State/province [308] 0 0
Chiba
Country [309] 0 0
Japan
State/province [309] 0 0
Chikushino-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Fukuoka-shi
Country [311] 0 0
Japan
State/province [311] 0 0
Fukuoka
Country [312] 0 0
Japan
State/province [312] 0 0
Gifu
Country [313] 0 0
Japan
State/province [313] 0 0
Hachioji
Country [314] 0 0
Japan
State/province [314] 0 0
Hamamatsu
Country [315] 0 0
Japan
State/province [315] 0 0
Hatsukaichi
Country [316] 0 0
Japan
State/province [316] 0 0
Hidaka
Country [317] 0 0
Japan
State/province [317] 0 0
Higashihiroshima-shi
Country [318] 0 0
Japan
State/province [318] 0 0
Himeji-shi
Country [319] 0 0
Japan
State/province [319] 0 0
Hiroshima-shi
Country [320] 0 0
Japan
State/province [320] 0 0
Hiroshima
Country [321] 0 0
Japan
State/province [321] 0 0
Ibaraki
Country [322] 0 0
Japan
State/province [322] 0 0
Ina-shi
Country [323] 0 0
Japan
State/province [323] 0 0
Ishikawa
Country [324] 0 0
Japan
State/province [324] 0 0
Kagoshima
Country [325] 0 0
Japan
State/province [325] 0 0
Kasuga-shi
Country [326] 0 0
Japan
State/province [326] 0 0
Kasugai-shi
Country [327] 0 0
Japan
State/province [327] 0 0
Kawasaki City
Country [328] 0 0
Japan
State/province [328] 0 0
Kitakyushu-shi
Country [329] 0 0
Japan
State/province [329] 0 0
Kobe-shi
Country [330] 0 0
Japan
State/province [330] 0 0
Koga
Country [331] 0 0
Japan
State/province [331] 0 0
Komoro-shi
Country [332] 0 0
Japan
State/province [332] 0 0
Kumamoto
Country [333] 0 0
Japan
State/province [333] 0 0
Kure
Country [334] 0 0
Japan
State/province [334] 0 0
Kurume-shi
Country [335] 0 0
Japan
State/province [335] 0 0
Kyoto-shi
Country [336] 0 0
Japan
State/province [336] 0 0
Maebashi
Country [337] 0 0
Japan
State/province [337] 0 0
Matsubara-shi
Country [338] 0 0
Japan
State/province [338] 0 0
Nagasaki-shi
Country [339] 0 0
Japan
State/province [339] 0 0
Nagoya-shi
Country [340] 0 0
Japan
State/province [340] 0 0
Nishinomiya-shi
Country [341] 0 0
Japan
State/province [341] 0 0
Okayama-shi
Country [342] 0 0
Japan
State/province [342] 0 0
Omuta-Shi
Country [343] 0 0
Japan
State/province [343] 0 0
Osaka-shi
Country [344] 0 0
Japan
State/province [344] 0 0
Osaka
Country [345] 0 0
Japan
State/province [345] 0 0
Ota-ku
Country [346] 0 0
Japan
State/province [346] 0 0
Saga
Country [347] 0 0
Japan
State/province [347] 0 0
Saitama-shi
Country [348] 0 0
Japan
State/province [348] 0 0
Sapporo-shi
Country [349] 0 0
Japan
State/province [349] 0 0
Sendai-shi
Country [350] 0 0
Japan
State/province [350] 0 0
Shimonoseki-shi
Country [351] 0 0
Japan
State/province [351] 0 0
Shimotsuke
Country [352] 0 0
Japan
State/province [352] 0 0
Shinjuku-ku
Country [353] 0 0
Japan
State/province [353] 0 0
Shizuoka Aoi-ku
Country [354] 0 0
Japan
State/province [354] 0 0
Suita-Shi
Country [355] 0 0
Japan
State/province [355] 0 0
Tokyo
Country [356] 0 0
Japan
State/province [356] 0 0
Toyoake
Country [357] 0 0
Japan
State/province [357] 0 0
Toyohasi-shi
Country [358] 0 0
Japan
State/province [358] 0 0
Toyota-shi
Country [359] 0 0
Japan
State/province [359] 0 0
Tsukuba City
Country [360] 0 0
Japan
State/province [360] 0 0
Urayasu-shi
Country [361] 0 0
Japan
State/province [361] 0 0
Uwajima-shi
Country [362] 0 0
Japan
State/province [362] 0 0
Yonezawa-shi
Country [363] 0 0
Korea, Republic of
State/province [363] 0 0
Anyang-si
Country [364] 0 0
Korea, Republic of
State/province [364] 0 0
Busan
Country [365] 0 0
Korea, Republic of
State/province [365] 0 0
Daegu
Country [366] 0 0
Korea, Republic of
State/province [366] 0 0
Goyang-si
Country [367] 0 0
Korea, Republic of
State/province [367] 0 0
Gwangju
Country [368] 0 0
Korea, Republic of
State/province [368] 0 0
Incheon
Country [369] 0 0
Korea, Republic of
State/province [369] 0 0
Jeju Special
Country [370] 0 0
Korea, Republic of
State/province [370] 0 0
Sejong-si
Country [371] 0 0
Korea, Republic of
State/province [371] 0 0
Seongnam-si
Country [372] 0 0
Korea, Republic of
State/province [372] 0 0
Seoul
Country [373] 0 0
Korea, Republic of
State/province [373] 0 0
Uijeongbu-si
Country [374] 0 0
Korea, Republic of
State/province [374] 0 0
Ulsan
Country [375] 0 0
Korea, Republic of
State/province [375] 0 0
Yongin si
Country [376] 0 0
Latvia
State/province [376] 0 0
Riga
Country [377] 0 0
Lithuania
State/province [377] 0 0
Vilnius
Country [378] 0 0
Malaysia
State/province [378] 0 0
Ipoh
Country [379] 0 0
Malaysia
State/province [379] 0 0
Klang
Country [380] 0 0
Malaysia
State/province [380] 0 0
Kota Bharu
Country [381] 0 0
Malaysia
State/province [381] 0 0
Kuala Lumpur
Country [382] 0 0
Malaysia
State/province [382] 0 0
Seberang Jaya
Country [383] 0 0
Malaysia
State/province [383] 0 0
Sungai Buloh
Country [384] 0 0
Mexico
State/province [384] 0 0
Aguascalientes
Country [385] 0 0
Mexico
State/province [385] 0 0
Ciudad de Mexico
Country [386] 0 0
Mexico
State/province [386] 0 0
Distrito Federal
Country [387] 0 0
Mexico
State/province [387] 0 0
Morelia
Country [388] 0 0
Mexico
State/province [388] 0 0
San Luis Potosi
Country [389] 0 0
Netherlands
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Breda
Country [390] 0 0
Netherlands
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Delft
Country [391] 0 0
Netherlands
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Uden
Country [392] 0 0
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State/province [392] 0 0
Auckland
Country [393] 0 0
New Zealand
State/province [393] 0 0
Hastings
Country [394] 0 0
New Zealand
State/province [394] 0 0
Otahuhu
Country [395] 0 0
New Zealand
State/province [395] 0 0
Rotorua
Country [396] 0 0
New Zealand
State/province [396] 0 0
Wellington
Country [397] 0 0
Philippines
State/province [397] 0 0
Cebu
Country [398] 0 0
Philippines
State/province [398] 0 0
Davao City
Country [399] 0 0
Philippines
State/province [399] 0 0
Iloilo
Country [400] 0 0
Philippines
State/province [400] 0 0
Lipa City
Country [401] 0 0
Philippines
State/province [401] 0 0
Manila
Country [402] 0 0
Philippines
State/province [402] 0 0
Marikina City
Country [403] 0 0
Philippines
State/province [403] 0 0
Pasay City
Country [404] 0 0
Philippines
State/province [404] 0 0
Pasig City
Country [405] 0 0
Philippines
State/province [405] 0 0
Quezon City
Country [406] 0 0
Philippines
State/province [406] 0 0
Quezon
Country [407] 0 0
Philippines
State/province [407] 0 0
San Fernando
Country [408] 0 0
Poland
State/province [408] 0 0
Bialystok
Country [409] 0 0
Poland
State/province [409] 0 0
Boleslawiec
Country [410] 0 0
Poland
State/province [410] 0 0
Bydgoszcz
Country [411] 0 0
Poland
State/province [411] 0 0
Chelmie
Country [412] 0 0
Poland
State/province [412] 0 0
Dzialdowo
Country [413] 0 0
Poland
State/province [413] 0 0
Grodzisk Mazowiecki
Country [414] 0 0
Poland
State/province [414] 0 0
Gryfice
Country [415] 0 0
Poland
State/province [415] 0 0
Katowice-Ochojec
Country [416] 0 0
Poland
State/province [416] 0 0
Krakow
Country [417] 0 0
Poland
State/province [417] 0 0
Leszno
Country [418] 0 0
Poland
State/province [418] 0 0
Lodz
Country [419] 0 0
Poland
State/province [419] 0 0
Lublin
Country [420] 0 0
Poland
State/province [420] 0 0
Olsztyn
Country [421] 0 0
Poland
State/province [421] 0 0
Rybnik
Country [422] 0 0
Poland
State/province [422] 0 0
Skarzysko-Kamienna
Country [423] 0 0
Poland
State/province [423] 0 0
Staszow
Country [424] 0 0
Poland
State/province [424] 0 0
Torun
Country [425] 0 0
Poland
State/province [425] 0 0
Warszawa
Country [426] 0 0
Poland
State/province [426] 0 0
Wejherowo
Country [427] 0 0
Portugal
State/province [427] 0 0
Braga
Country [428] 0 0
Portugal
State/province [428] 0 0
Coimbra
Country [429] 0 0
Portugal
State/province [429] 0 0
Covilha
Country [430] 0 0
Portugal
State/province [430] 0 0
Guimaraes
Country [431] 0 0
Portugal
State/province [431] 0 0
Lisboa
Country [432] 0 0
Portugal
State/province [432] 0 0
Porto
Country [433] 0 0
Portugal
State/province [433] 0 0
Santa Maria da Feira
Country [434] 0 0
Portugal
State/province [434] 0 0
Vila Nova de Gaia
Country [435] 0 0
Portugal
State/province [435] 0 0
Vila Real
Country [436] 0 0
Romania
State/province [436] 0 0
Arad
Country [437] 0 0
Romania
State/province [437] 0 0
Brasov
Country [438] 0 0
Romania
State/province [438] 0 0
Bucuresti
Country [439] 0 0
Romania
State/province [439] 0 0
Constanta
Country [440] 0 0
Romania
State/province [440] 0 0
Targu Mures
Country [441] 0 0
Romania
State/province [441] 0 0
Timisoara
Country [442] 0 0
Serbia
State/province [442] 0 0
Belgrade
Country [443] 0 0
Serbia
State/province [443] 0 0
Kragujevac
Country [444] 0 0
Serbia
State/province [444] 0 0
Sombor
Country [445] 0 0
Serbia
State/province [445] 0 0
Subotica
Country [446] 0 0
Serbia
State/province [446] 0 0
Uzice
Country [447] 0 0
Singapore
State/province [447] 0 0
Singapore
Country [448] 0 0
Slovakia
State/province [448] 0 0
Banska Bystrica
Country [449] 0 0
Slovakia
State/province [449] 0 0
Bratislava
Country [450] 0 0
Slovakia
State/province [450] 0 0
Kosice
Country [451] 0 0
Slovakia
State/province [451] 0 0
Levice
Country [452] 0 0
Slovakia
State/province [452] 0 0
Lucenec
Country [453] 0 0
Slovakia
State/province [453] 0 0
Martin
Country [454] 0 0
Slovakia
State/province [454] 0 0
Nové Zámky
Country [455] 0 0
Slovakia
State/province [455] 0 0
Petrzalka
Country [456] 0 0
Slovakia
State/province [456] 0 0
Spisska Nova Ves
Country [457] 0 0
Slovakia
State/province [457] 0 0
Trebisov
Country [458] 0 0
Slovakia
State/province [458] 0 0
Trencin
Country [459] 0 0
Slovakia
State/province [459] 0 0
Zilina
Country [460] 0 0
South Africa
State/province [460] 0 0
Bloemfontein
Country [461] 0 0
South Africa
State/province [461] 0 0
Cape Town
Country [462] 0 0
South Africa
State/province [462] 0 0
East London
Country [463] 0 0
South Africa
State/province [463] 0 0
George
Country [464] 0 0
South Africa
State/province [464] 0 0
Johannesburg
Country [465] 0 0
South Africa
State/province [465] 0 0
Somerset West
Country [466] 0 0
South Africa
State/province [466] 0 0
Tongaat
Country [467] 0 0
South Africa
State/province [467] 0 0
Worcester
Country [468] 0 0
Spain
State/province [468] 0 0
Albacete
Country [469] 0 0
Spain
State/province [469] 0 0
Alicante
Country [470] 0 0
Spain
State/province [470] 0 0
Badalona
Country [471] 0 0
Spain
State/province [471] 0 0
Barakaldo
Country [472] 0 0
Spain
State/province [472] 0 0
Barcelona
Country [473] 0 0
Spain
State/province [473] 0 0
Cordoba
Country [474] 0 0
Spain
State/province [474] 0 0
Girona
Country [475] 0 0
Spain
State/province [475] 0 0
L'Hospitalet de Llobregat
Country [476] 0 0
Spain
State/province [476] 0 0
La Coruña
Country [477] 0 0
Spain
State/province [477] 0 0
Lleida
Country [478] 0 0
Spain
State/province [478] 0 0
Madrid
Country [479] 0 0
Spain
State/province [479] 0 0
Malaga
Country [480] 0 0
Spain
State/province [480] 0 0
Mostoles
Country [481] 0 0
Spain
State/province [481] 0 0
Palma de Mallorca
Country [482] 0 0
Spain
State/province [482] 0 0
Salamanca
Country [483] 0 0
Spain
State/province [483] 0 0
Santiago de Compostela
Country [484] 0 0
Spain
State/province [484] 0 0
Sevilla
Country [485] 0 0
Spain
State/province [485] 0 0
Tarragona
Country [486] 0 0
Spain
State/province [486] 0 0
Terrassa
Country [487] 0 0
Spain
State/province [487] 0 0
Valencia
Country [488] 0 0
Spain
State/province [488] 0 0
Valladolid
Country [489] 0 0
Spain
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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
Other
Name [1] 0 0
Bristol Myers Squibb Company (BMS)
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
Participate-In-This-Study@its.jnj.com
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/NCT05702034