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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05757869




Registration number
NCT05757869
Ethics application status
Date submitted
24/02/2023
Date registered
7/03/2023

Titles & IDs
Public title
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Scientific title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
Secondary ID [1] 0 0
70033093AFL3002
Secondary ID [2] 0 0
CR109220
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Milvexian - Participants will receive milvexian 100 milligrams (mg) orally, twice daily and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.

Active comparator: Apixaban - Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Treatment: Drugs: Apixaban
Apixaban will be administered orally.

Treatment: Drugs: Placebo
Milvexian matching milvexian placebo will be administered orally.

Treatment: Drugs: Apixaban Placebo
Apixaban matching apixaban 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 the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Time to CV Death
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature
Timepoint [6] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Minimum age of 18 years
* Medically stable and appropriate for chronic antithrombotic treatment
* Atrial fibrillation eligible to receive anticoagulation
* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
* Any condition other than AF that requires chronic anticoagulation

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 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
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)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Advara HeartCare Wesley - Brisbane
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Peninsula Heart Center - Frankston
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [6] 0 0
GenesisCare Joondalup-Shenton House - Joondalup
Recruitment hospital [7] 0 0
Novatrials - Kotara
Recruitment hospital [8] 0 0
GenesisCare - Leabrook
Recruitment hospital [9] 0 0
Core Research Group - Milton
Recruitment hospital [10] 0 0
Brisbane Health Connect - Tarragindi
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
6027 - Joondalup
Recruitment postcode(s) [7] 0 0
2289 - Kotara
Recruitment postcode(s) [8] 0 0
5068 - Leabrook
Recruitment postcode(s) [9] 0 0
4064 - Milton
Recruitment postcode(s) [10] 0 0
4121 - Tarragindi
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Germany
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Wermsdorf
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Germany
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Worms
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Greece
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Alexandroupolis
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Hungary
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Baja
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hatvan
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Hungary
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Hodmezovasarhely
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Hungary
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Kaposvar
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Hungary
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Hungary
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Hungary
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Hungary
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Nyiregyhaza
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Israel
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Israel
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Hadera
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Israel
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar-Sava
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Israel
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Nazareth
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Israel
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Petah Tikva
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Israel
State/province [247] 0 0
Ramat Gan
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Israel
State/province [248] 0 0
Rechovot
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Israel
State/province [249] 0 0
Rishon Lezion
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Israel
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Safed
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Israel
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Yerushalayim
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Italy
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Arezzo
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Italy
State/province [253] 0 0
Aversa
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Italy
State/province [254] 0 0
Bergamo
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Italy
State/province [255] 0 0
Bologna
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Italy
State/province [256] 0 0
Caserta
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Italy
State/province [257] 0 0
Catania
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Italy
State/province [258] 0 0
Catanzaro
Country [259] 0 0
Italy
State/province [259] 0 0
Ferrara
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Italy
State/province [260] 0 0
Lecco
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Italy
State/province [261] 0 0
Massa
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Italy
State/province [262] 0 0
Milano
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Italy
State/province [263] 0 0
Monza
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Italy
State/province [264] 0 0
Pavia
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Italy
State/province [265] 0 0
Pisa
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Italy
State/province [266] 0 0
Roma
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Italy
State/province [267] 0 0
Rozzano
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Italy
State/province [268] 0 0
Sassari
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Italy
State/province [269] 0 0
Torino
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Italy
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Torrette Di Ancona
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Japan
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Aichi
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Japan
State/province [272] 0 0
Bunkyo Ku
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Japan
State/province [273] 0 0
Chiba
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Japan
State/province [274] 0 0
Chikushino-shi
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Japan
State/province [275] 0 0
Fukuoka
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Japan
State/province [276] 0 0
Funabashi-shi
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Japan
State/province [277] 0 0
Gifu
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Japan
State/province [278] 0 0
Higashiibaraki-gun
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Japan
State/province [279] 0 0
Hirosaki-shi
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Japan
State/province [280] 0 0
Hiroshima shi
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Japan
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Hiroshima-shi
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Japan
State/province [282] 0 0
Hokkaido
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Japan
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Hyogo
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Japan
State/province [284] 0 0
Isehara
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Japan
State/province [285] 0 0
Ishikawa
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Japan
State/province [286] 0 0
Itabashi Ku
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Japan
State/province [287] 0 0
Kagoshima-shi
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Japan
State/province [288] 0 0
Kasuga-shi
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Japan
State/province [289] 0 0
Kawasaki-shi
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Japan
State/province [290] 0 0
Kitakyushu-shi
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Japan
State/province [291] 0 0
Kumamoto-shi
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Japan
State/province [292] 0 0
Kumamoto
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Japan
State/province [293] 0 0
Kusatsu-shi
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Japan
State/province [294] 0 0
Kyoto-shi
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Japan
State/province [295] 0 0
Matsuyama-shi
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Japan
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Mito-shi
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Japan
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Miyazaki-shi
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Japan
State/province [298] 0 0
Miyazaki
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Japan
State/province [299] 0 0
Nagoya-shi
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Japan
State/province [300] 0 0
Narashino-shi
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Japan
State/province [301] 0 0
Nishinomiya-shi
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Japan
State/province [302] 0 0
Nishitokyo-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Okayama-shi
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Japan
State/province [304] 0 0
Okinawa
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Japan
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Osaka Sayama shi
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Japan
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Osaka-shi
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Japan
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Osaka
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Japan
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Sagamihara
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Japan
State/province [309] 0 0
Saitama-shi
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Japan
State/province [310] 0 0
Sapporo-shi
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Japan
State/province [311] 0 0
Sendai shi
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Japan
State/province [312] 0 0
Shinagawa
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Japan
State/province [313] 0 0
Shinjuku-ku
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Japan
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Suita-Shi
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Japan
State/province [315] 0 0
Takatsuki-shi
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Japan
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Tokyo
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Japan
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Japan
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Toyoake
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Japan
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Uwajima-shi
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Japan
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Poland
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Gdynia
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Poland
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Grodzisk Mazowiecki
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Poland
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Jelenia Góra
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Poland
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Poland
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Portugal
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Santa Maria da Feira
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Portugal
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Torres Novas
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Portugal
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Portugal
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Vila Real
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Baia Mare
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Romania
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Braila
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Brasov
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Romania
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Bucharest
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Pitesti
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Romania
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Sibiu
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Romania
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Suceava
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Romania
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Targu Mures
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Romania
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Tg. Mures
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Romania
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Timisoara
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Niska Banja
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Serbia
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Nis
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Serbia
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Pancevo
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Serbia
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Smederevo
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Serbia
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Sremska Mitrovica
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Serbia
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Zajecar
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Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Brezno
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Dolny Kubin
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Slovakia
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Kosice
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Slovakia
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Slovakia
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Lucenec
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Slovakia
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Moldava nad Bodvou
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Slovakia
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Nitra
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Slovakia
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Nove Zamky
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Slovakia
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Presov
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Slovakia
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Prešov
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Slovakia
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Svidnik
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Slovakia
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Zilina
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South Africa
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Cape Town
Country [451] 0 0
South Africa
State/province [451] 0 0
Centurion
Country [452] 0 0
South Africa
State/province [452] 0 0
Johannesburg
Country [453] 0 0
South Africa
State/province [453] 0 0
Krugersdorp
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South Africa
State/province [454] 0 0
Pretoria
Country [455] 0 0
South Africa
State/province [455] 0 0
Somerset West
Country [456] 0 0
South Africa
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Tongaat
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South Africa
State/province [457] 0 0
Worcester
Country [458] 0 0
Spain
State/province [458] 0 0
A Coruña
Country [459] 0 0
Spain
State/province [459] 0 0
Alicante
Country [460] 0 0
Spain
State/province [460] 0 0
Barcelona
Country [461] 0 0
Spain
State/province [461] 0 0
El Palmar
Country [462] 0 0
Spain
State/province [462] 0 0
Lleida
Country [463] 0 0
Spain
State/province [463] 0 0
Madrid
Country [464] 0 0
Spain
State/province [464] 0 0
Malaga
Country [465] 0 0
Spain
State/province [465] 0 0
Manises
Country [466] 0 0
Spain
State/province [466] 0 0
Santiago de Compostela
Country [467] 0 0
Spain
State/province [467] 0 0
Valencia
Country [468] 0 0
Taiwan
State/province [468] 0 0
Changhua
Country [469] 0 0
Taiwan
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Kaohsiung
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Taiwan
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New Taipei
Country [471] 0 0
Taiwan
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Taichung
Country [472] 0 0
Taiwan
State/province [472] 0 0
Taipei City
Country [473] 0 0
Taiwan
State/province [473] 0 0
Taipei
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Taiwan
State/province [474] 0 0
Taoyuan County
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Bristol
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United Kingdom
State/province [476] 0 0
Clydebank
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United Kingdom
State/province [477] 0 0
Dorchester
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United Kingdom
State/province [478] 0 0
High Wycombe
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United Kingdom
State/province [479] 0 0
Lincoln
Country [480] 0 0
United Kingdom
State/province [480] 0 0
London
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Sheffield
Country [482] 0 0
United Kingdom
State/province [482] 0 0
Truro
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Wigan

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
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.