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Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02798471
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism (VTE) Pulmonary Embolism Deep Vein Thrombosis (DVT) Drug: Edoxaban Drug: Standard of Care Phase 3

Detailed Description:
The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Edoxaban

Arm Intervention/treatment
Experimental: Edoxaban

Edoxaban treatment will be dispensed to the participant on a monthly visit schedule.

Edoxaban will be started orally at the age/weight/renal function appropriate dose, depending on the results of the ongoing U157 study (NCT02303431) for the Treatment Period.

Drug: Edoxaban
15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age

Experimental: Standard of Care
Standard of Care (SOC) treatment will be dispensed to the participant on a monthly visit schedule.
Drug: Standard of Care
Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
Other Names:
  • Warfarin/heparin
  • Enoxaparin
  • Fondaparinux




Primary Outcome Measures :
  1. Composite and adjudicated endpoint: symptomatic recurrent VTE [ Time Frame: During the First 3-Month Period ]
    Diagnosis of recurrent VTE requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis

  2. Composite and adjudicated endpoint: death as a result of VTE [ Time Frame: During the First 3-Month Period ]
    Death from VTE is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out

  3. Composite and adjudicated endpoint: no change or extension of thrombotic burden [ Time Frame: During the First 3-Month Period ]
    No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3


Secondary Outcome Measures :
  1. Composite and adjudicated endpoints: Major bleeding [ Time Frame: During the First 3-Month Period ]
    Major bleeding is defined as a composite of any of the following: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system.

  2. Composite and adjudicated endpoints: Clinically relevant non-major bleeding [ Time Frame: During the First 3-Month Period ]
    Defined as either of the following: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition, bleeding that requires medical or surgical or percutaneous intervention to restore hemostasis other than in an operating suite.

  3. Composite and adjudicated endpoints of: Symptomatic recurrent VTE, death as a result of VTE and major and clinically relevant non-major bleeding. [ Time Frame: During the First 3-Month Period + 30 Days ]
    Assessments of this outcome is similar to those identified for outcomes 1, 2, 4, 5

  4. Pharmacokinetics of Edoxaban: Peak plasma concentration (Cmax) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PK parameter

  5. Pharmacokinetics of Edoxaban: Area under the plasma concentration vs. time curve (AUC) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PK parameter

  6. Pharmacokinetics of Edoxaban: Apparent systemic clearance (CL/F) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PK parameter

  7. Pharmacokinetics of Edoxaban: Apparent volume of distribution (V/F) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PK parameter

  8. Pharmacodynamics of Edoxaban: Prothrombin time (PT) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PD parameter

  9. Pharmacodynamics of Edoxaban: Activated partial thromboplastin time (aPTT) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PD parameter

  10. Pharmacodynamics of Edoxaban: Anti-activated factor X (Anti-FXa) [ Time Frame: Treatment Day 5 sparse blood sampling ]
    PD parameter



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female pediatric subjects between birth (defined as 38 weeks gestational age) and less than 18 years of age at the time of consent.
  2. Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days.
  3. Subjects must have received at least 5 days of heparin therapy prior to randomization to treat the newly identified index VTE. In addition, prior to being randomized to edoxaban or SOC, subjects initially treated with VKA are recommended to have an international normalized ratio (INR) < 2.0.
  4. Subject and/or parent(s)/legal guardian(s) or legally acceptable representative is informed and provides signed consent for the child to participate in the study.
  5. Female subjects who have menarche must test negative for pregnancy at Screening and must consent to avoid becoming pregnant by using an approved contraception method throughout the study.

Exclusion Criteria:

  1. Subjects with active bleeding or high risk of bleeding contraindicating treatment with LMWH, SP Xa inhibitors, VKAs, or direct oral anticoagulants (DOACs; identified high risk of bleeding during prior experimental administration of DOACs).
  2. Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE.
  3. Administration of antiplatelet therapy is contraindicated in both arms except for low dose aspirin defined as 1-5 mg/Kg/day with maximum of 100 mg/day.
  4. Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded.
  5. Subjects with hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk (aPTT > 50 seconds or international normalized ratio [INR] > 2.0 not related to anticoagulation therapy) or alanine aminotransferase (ALT) > 5 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN with direct bilirubin > 20% of the total at Screening Visit.
  6. Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size as determined by the Schwartz formula.
  7. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed > 99th percentile + 5 mmHg.
  8. Subject with thrombocytopenia < 50 × 109/L at Screening Visit. Subjects with a history of heparin-induced thrombocytopenia may be enrolled in the study at the Investigator's discretion.
  9. Life expectancy less than the expected study treatment duration (3 months).
  10. Subjects who are known to be pregnant or breastfeeding.
  11. Subjects with any condition that, as judged by the Investigator, would place the subject at increased risk of harm if he/she participated in the study, including contraindicated medications.
  12. Subjects who participated in another clinical study or treated with an experimental therapy with less than a 30 day washout period prior to identifying the qualifying index VTE.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798471


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Locations
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United States, Arizona
Banner University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Site Coordinator    520-694-3325    bhasin@peds.arizona.edu   
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Site Coordinator    323-361-3478    jjaffray@chla.usc.edu   
UCLA Medical Center CAR Recruiting
Los Angeles, California, United States, 90095
Contact: Site Coordinator    310-825-9111    groach@mednet.ucla.edu   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305-2200
Contact: Site Coordinator    650-723-5535    mjeng@stanford.edu   
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Site Coordinator    305-243-6925    lfp34@miami.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Site Coordinator    813-259-8813    jrico@health.usf.edu   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Coordinator    312-563-1883    Brian_H_Jenkins@rush.edu   
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453-2699
Contact: Site Coordinator    708-684-4576    marie-ellen.sarvida@advocatehealth.com   
United States, Indiana
Indiana Hemophilia and Thrombosis Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Site Coordinator    317-871-0011 ext 218    sgupta@ihtc.org   
United States, Kentucky
University of Louisville Terminated
Louisville, Kentucky, United States, 40202
United States, Michigan
Spectrum Health Helen DeVos Children's Hospital Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Site Coordinator    616-391-8534    chi.braunreiter@helendevoschildrens.org   
United States, Minnesota
Children's Hospital & Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Site Coordinator    612-813-6969    Ashley.Kinsella@childrensmn.org   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Coordinator    314-454-6147    canter@wustl.edu   
United States, North Carolina
University North Carolina- Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Site Coordinator    919-843-3801    marcus_layer@med.unc.edu   
Levine Children's Hospital Charlotte Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Site Coordinator    980-442-2356    ashley.hinson@carolinashealthcare.org   
The Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Site Coordinator    704-384-5369    cybolen@novanthealth.org   
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Contact: Site Coordinator    252-744-4773    cortrightl16@ecu.edu   
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Coordinator    405-271-3661    osman-khan@ouhsc.edu   
United States, Rhode Island
Hasbro Children's Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Site Coordinator    401-444-5241    achawla@lifespan.org   
United States, Tennessee
Le Bonheur Childrens Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Coordinator    901-287-7457    malsheik@uthsc.edu   
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Site Coordinator    901-595-2097    ulrike.reiss@stjude.org   
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226-4874
Contact: Site Coordinator    414-266-3360    rniebler@mcw.edu   
Argentina
Hospital Italiano Regional del Sur Recruiting
Buenos Aires, Argentina, B8001HXM
Contact: Site Coordinator    +54 92916483724    cdiazarguello@yahoo.com.ar   
Sanatorio Allende Recruiting
Cordoba, Argentina, X5000JHQ
Contact: Site Coordinator    +54 3514269200 ext 1661    nsupertino@sanatorioallende.com   
Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Recruiting
Curitiba, Paraná, Brazil, 81520-060
Contact: Site Coordinator    +55 4133615251    albonei@yahoo.com.br   
IMIP - Instituto de Medicina Integral Professor Fernando Figueira Recruiting
Pernambuco, Recife, Brazil, 50070-550
Contact: Site Coordinator    + 55 8121224792    thais.lima@imip.org.br   
Hospital São Vicente de Paulo Recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Contact: Site Coordinator    +55 5435811831    jcbajerski@yahoo.com.br   
Hospital da Cidade de Passo Fundo Recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-260
Contact: Site Coordinator    +55 5421033490    priscila.foscarini@hcpf.com.br   
Instituto de Cardiologia do Rio Grande do Sul Recruiting
Pôrto Alegre, Rio Grande Do Sul, Brazil, 90620-001
Contact: Site Coordinator    +55 5132303860    lais.pesclinica@cardiologia.org.br   
Hospital de Câncer de Barretos - Fundação Pio XII Recruiting
Barretos, São Paulo, Brazil, 14784-400
Contact: Site Coordinator    +55 1733216637    robsonccoelho1511@gmail.com   
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP Recruiting
Campinas, São Paulo, Brazil, 13083-878
Contact: Site Coordinator    +55 1935218630    pesquisaclinica.hemo@hotmail.com   
Centro Multidisciplinar de Estudos Clínicos - CEMEC Recruiting
Santo André, São Paulo, Brazil, 09190-510
Contact: Site Coordinator    +55 1123794095    cor.jantonio@gmail.com   
Santa Casa de Votuporanga Recruiting
Votuporanga, São Paulo, Brazil, 15500-003
Contact: Site Coordinator    +55 1734235306    vhcfaria@hotmail.co   
Hospital Samaritano Recruiting
São Paulo, Brazil, 01232-010
Contact: Site Coordinator    +55 1138215727    miapita9@yahoo.com.br   
Hospital da Luz Amico Saude LTDA Recruiting
São Paulo, Brazil, 04013-060
Contact: Site Coordinator    +55 1121176128    evnascimento@hospitaldaluz.com.br   
Hospital Infantil Pequeno Príncipe Recruiting
São Paulo, Brazil, 04013-060
Contact: Site Coordinator    +55 4133101356    leonardo.soares@hpp.org.br   
GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer Recruiting
São Paulo, Brazil, 04039-001
Contact: Site Coordinator    +55 1150808575    marcelazi@graacc.org.br   
UNIFESP - Universidade Federal de São Paulo Recruiting
São Paulo, Brazil, 04039-032
Contact: Site Coordinator    +55 1155792581    vtvascon@hotmail.com   
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Site Coordinator    +55 11992667092    juliana.caires@hc.fm.usp.br   
HMCG - Hospital e Maternidade Dr. Christovão da Gama Recruiting
São Paulo, Brazil, 09030-010
Contact: Site Coordinator    +55 1144688183    eduardoramacciotti@gmail.com   
Bulgaria
UMHAT "Sv. Georgi", EAD Recruiting
Plovdiv, Bulgaria, 4000
Contact: Site Coordinator    +359 898994199    lbukova@yahoo.com   
MHAT - "National Heart Hospital" EAD Recruiting
Sofia, Bulgaria, 1309
Contact: Site Coordinator    +359 9201471    levunlieva@gmail.com   
MHAT 'Tokuda Hospital Sofia', EAD Recruiting
Sofia, Bulgaria, 1407
Contact: Site Coordinator    +359 884933080    r_maslarska17@abv.bg   
Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases Recruiting
Sofia, Bulgaria, 1612
Contact: Site Coordinator    +359 888952925    raligeorgi@yahoo.com   
Canada, Alberta
Edmonton Clinic Health Academy Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Site Coordinator    780-248-5519    patti.massicotte@ahs.ca   
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Site Coordinator    204-787-2196    rhiebert5@cancercare.mb.ca   
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Site Coordinator    905-521-2100 ext 76054    hamiltonko@hhsc.ca   
Chile
Hospital El Carmen Dr. Luis Valentin Ferrada Recruiting
Maipu, Chile, 9251521
Contact: Site Coordinator    +56 931207816    tmmedinar@gmail.com   
Clinica Las Condes Recruiting
Santiago, Chile, 7591047
Contact: Site Coordinator    +56 994036574    mamartinez@clinicalascondes.cl   
Hospital Clinico Pontificia Universidad Catolica de Chile Withdrawn
Santiago, Chile, 8330024
Croatia
Clinical Hospital Centre Rijeka Recruiting
Rijeka, Croatia, 51000
Contact: Site Coordinator    +385 911743530    roganovic.kbcri@gmail.com   
General Hospital Zadar Recruiting
Zadar, Croatia, 23000
Contact: Site Coordinator    +385 917618409    andreasimic31@gmail.com   
Children's Hospital Zagreb Recruiting
Zagreb, Croatia, 10 000
Contact: Site Coordinator    +385 16445784    mkanceljak@gmail.com   
University Hospital Centre Zagreb, University of Zagreb School of Medicine Recruiting
Zagreb, Croatia, 10000
Contact: Site Coordinator    +385 12388701    danica.grguric@hotmail.com   
Czechia
Fakultni nemocnice Brno Recruiting
Brno, Czechia, 613 00
Contact: Site Coordinator    +420 532234244    blatny.jan@fnbrno.cz   
CTC Hodonin s.r.o. Recruiting
Hodonin, Czechia, 69501
Contact: Site Coordinator    +420 774338869    lenka.chybova@matmed.cz   
Dětská klinika Fakultní nemocnice Recruiting
Hradec Králové, Czechia, 500 05
Contact: Site Coordinator    +420 608782615    erika.ondrusova@fnhk.cz   
University Hospital Pilsen, CZ Recruiting
Plzen, Czechia, 305 99
Contact: Site Coordinator    +420 377104333    votavat@fnplzen.cz   
Denmark
Ålborg Universitetshospital Recruiting
Aalborg, Denmark, 9000
Contact: Site Coordinator    +45 97663434    rt@rn.dk   
El Salvador
Hospital Nacional de Niños Benjamín Bloom Recruiting
San Salvador, Salvador, El Salvador
Contact: Site Coordinator    +503 77973525    abocaletti@cidal.net   
France
Clinical Hospital Centre Cavale Blanche BREST Recruiting
Brest, Finistere, France, 29200
Contact: Site Coordinator    +33 298145162    francis.couturaud@chu-brest.fr   
Groupe Hospitalier Sud - Hôpital Haut-Lévêque Recruiting
Pessac, Gironde, France, 33600
Contact: Site Coordinator    +33 557674561    pierre-emmanuel.seguela@chu-bordeaux.fr   
Hôpital des enfants, CHU Toulouse Recruiting
Toulouse, Haute Garonne, France, 31059
Contact: Site Coordinator    +33 567771095    auriol.f@chu-toulouse.fr   
CHU Rennes - Hopital Sud Recruiting
Rennes, Ille Et Vilaine, France, 35203
Contact: Site Coordinator    +33 299267134    sophie.bayart@chu-rennes.fr   
CHU Angers - Hôpital Hôtel Dieu Terminated
Angers, France, 49100
CHU Clermont Ferrand - Hôpital d'Estaing Recruiting
Clermont-Ferrand, France, 63003
Contact: Site Coordinator    +33 473755179    ausclade@chu-clermontferrand.fr   
CHU Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Site Coordinator    +33 467332330    mirna-khalil@chu-montpellier.fr   
Germany
Charite - Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Site Coordinator    +49 30450666215    susanne.holzhauer@charite.de   
Guatemala
Unidad de Cirugía Cardiovascular de Guatemala (UNICAR) Recruiting
Guatemala, Guatemala
Contact: Site Coordinator    +502 59305827    gmogaitan@yahoo.com   
Unidad Nacional de Oncología Pediátrica (UNOP) Recruiting
Guatemala, Guatemala
Contact: Site Coordinator    502-5901-0669    mariomelgar@estudiosgt.org   
Hungary
Semmelweis University 2nd Department of Pediatrics Recruiting
Budapest, Hungary, 1094
Contact: Site Coordinator    +36 203585911    sara.poszmik@coordination.hu   
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases Recruiting
Budapest, Hungary, H-1097
Contact: Site Coordinator    +36 306945046    hunpedhsct.coordinator@gmail.com   
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, 4032
Contact: Site Coordinator    +36 52411600    kisscs@med.unideb.hu   
University of Szeged, Department of Pediatrics Recruiting
Szeged, Hungary, 6720
Contact: Site Coordinator    +36 62545330    bereczki.csaba@med.u-szeged.hu   
India
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Site Coordinator    +91 8130811468    js.jyoti001@gmail.com   
Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education Recruiting
Karamsad, Gujarat, India, 388325
Contact: Site Coordinator    +91 9974169880    utsavbp@charutarhealth.org   
Nirmal Hospital Recruiting
Surat, Gujarat, India, 395002
Contact: Site Coordinator    +91 2612333999    drjashvant.patel@gmail.com   
Jain Institute of Vascular Sciences Recruiting
Bangalore, Karnataka, India, 560052
Contact: Site Coordinator    +91 800419993    doc_kal@hotmail.com   
M. S. Ramaiah Medical College and Hospital Recruiting
Bangalore, Karnataka, India, 560054
Contact: Site Coordinator    +91 8040502982    info@msrcrc.com   
Government Medical College and Hospital Recruiting
Nagpur, Maharashtra, India, 440003
Contact: Site Coordinator    +91 8554999691    mohiniapte@yahoo.co.in   
Christian Medical College Recruiting
Ludhiana, Punjab, India, 141008
Contact: Site Coordinator    +91 1615026999    gibbs.narang@yahoo.com   
Institute of Child Health Recruiting
Kolkata, West Bengal, India, 700017
Contact: Site Coordinator    +91 3322902305    monjorimr@gmail.com   
Indraprastha Apollo Hospitals Recruiting
Delhi, India, 110076
Contact: Site Coordinator    +91 1126925858    drreetesh22@gmail.com   
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 3109601
Contact: Site Coordinator    +972 522471142    n_tuma@rambam.health.gov.il   
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Site Coordinator    +972 25645675    Joleenist@szmc.org.il   
Hadassah ein Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Site Coordinator    +972 544701111    galg@hadassah.org.il   
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Site Coordinator    +972 35302950    gili.kenet@sheba.health.gov.il   
Kenya
Strathmore University Medical Centre Recruiting
Nairobi, Kenya, 59857-00200
Contact: Site Coordinator    +254 721945362    Asalim@strathmore.edu   
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Site Coordinator    +82 317873969    98935@snubh.org   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 3080
Contact: Site Coordinator    +82 220723452    edy-jang@hanmail.net   
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 3722
Contact: Site Coordinator    +82 222282060    cj@yuhs.ac   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Contact: Site Coordinator    +82 234103532    hema2170@skku.edu   
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 1107 2020
Contact: Site Coordinator    +961 1350000 ext 5500    jm72@aub.edu.lb   
Saint George University Hospital Medical Center Recruiting
Beirut, Lebanon, 166378
Contact: Site Coordinator    +961 1441000    peter.noun@yahoo.com   
Hotel Dieu de France Hospital Recruiting
Beirut, Lebanon, 166830
Contact: Site Coordinator    +961 3704864    claudiakhayat@yahoo.fr   
Malaysia
Hospital Raja Perempuan Zainab II Recruiting
Kota Bharu, Kelantan, Malaysia, 15586
Contact: Site Coordinator    +60 97452000    ameaz76@yahoo.com   
Netherlands
Erasmus MC Sophia Recruiting
Rotterdam, Netherlands, 3000 CB
Contact: Site Coordinator    +31 628287905    a.vanderheide.1@erasmusmc.nl   
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 15-274
Contact: Site Coordinator    +48 604640977    heidi.glosli@oslo-universitetssykehus.no   
Panama
Indicasat Aip Recruiting
Panamá, Panama, 0843-01103
Contact: Site Coordinator    507-6980-4535    iquintero@indicasat.org.pa   
Portugal
Hospital de Braga Recruiting
Braga, Portugal, 4710-243
Contact: Site Coordinator    +35 125307190    almerindabarrosopereira@gmail.com   
Hospital da Senhora da Oliveira Recruiting
Guimarães, Portugal, 4835-044
Contact: Site Coordinator    +351 910120513    jvale@blueclinical.pt   
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta Recruiting
Lisboa, Portugal, 1169-1024
Contact: Site Coordinator    +351 213594315    mafalda.selas@gmail.com   
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria Recruiting
Lisboa, Portugal, 1649-035
Contact: Site Coordinator    +351 210405814    anabelamrmorais@gmail.com   
Russian Federation
FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA" Terminated
Kirov, Russian Federation, 610027
Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology Recruiting
Moscow, Russian Federation, 117997
Contact: Site Coordinator    +7 9165791600    elena.abbasova11@mail.ru   
Serbia
Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic" Recruiting
Belgrade, Serbia, 11070
Contact: Site Coordinator    +381 113108245    mmilosbg@gmail.com   
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Contact: Site Coordinator    +381 34505177    igzor@medf.kg.ac.rs   
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Site Coordinator    +65 66012533    paekpl@nus.edu.sg   
KK Women's And Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Site Coordinator    +65 63926343    joyce.lam.c.m@singhealth.com.sg   
Slovenia
University Medical Centre Ljubljana Terminated
Ljubljana, Slovenia, 1000
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Contact: Site Coordinator    +34 932746061    asantamaria@vhebron.net   
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Site Coordinator    +34 912071466    fjcliment@gmail.com   
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Site Coordinator    +34 637915253    nuriaconde@hotmail.com   
Hospital Universitario Araba Recruiting
Vitoria, Álava, Spain, 01009
Contact: Site Coordinator    +34 645007252    Ensayosclinicos.bioaraba@osakidetza.eus   
Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien City, Taiwan, 970
Contact: Site Coordinator    +886 3856182    hermann_yang@hotmail.com   
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81362
Contact: Site Coordinator    +886 73422121    kenpenweng@yahoo.com.tw   
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Site Coordinator    +886 422052121    mdsb1979@gmail.com   
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact: Site Coordinator    +886 97535156    linghua127@gmail.com   
Taipei Medical University Hospital Recruiting
Taipei City, Taiwan, 11031
Contact: Site Coordinator    +886 27372181    996179@h.tmu.edu.tw   
Thailand
Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10300
Contact: Site Coordinator    +66 22011749    nongnuch.sir@mahidol.ac.th   
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Site Coordinator    +66 22564949    dsosothikul@hotmail.com   
Phramongkutklao Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Site Coordinator    +66 23547600    ctrivaree@yahoo.com   
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Site Coordinator    +66 53935420    somjai.s@cmu.ac.th   
Srinagarind Hospital Recruiting
Khon Kaen, Thailand, 40002
Contact: Site Coordinator    +66 43348382    patkomwi@gmail.com   
Songklanagarind Hospital Recruiting
Songkhla, Thailand, 90110
Contact: Site Coordinator    +66 74455000    cthirachit@yahoo.com   
Turkey
Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department Recruiting
Adana, Turkey, 1330
Contact: Site Coordinator    +90 5360652188    funda.balci@atlascro.com.tr   
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 6100
Contact: Site Coordinator    +90 31223051 17    suleunal@hacettepe.edu.tr   
Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi Recruiting
Ankara, Turkey, 6110
Contact: Site Coordinator    +90 3125969600    namikyozbek@gmail.com   
Istanbul University Istanbul Medical Faculty Recruiting
Istanbul, Turkey, 34093
Contact: Site Coordinator    +90 5309672608    gozde.canli@atlascro.com.tr   
Yeditepe University Oncology Hospital Recruiting
Istanbul, Turkey, 34718
Contact: Site Coordinator    +90 5558816878    sabri.kemahli@yeditepe.edu.tr   
Ege University Medical Faculty Recruiting
Izmir, Turkey, 35040
Contact: Site Coordinator    +90 2323901017    kaan.kavakli@ege.edu.tr   
Izmir Tepecik Training and Research Hospital Recruiting
Izmir, Turkey, 35170
Contact: Site Coordinator    +90 5072826023    barismalbora@gmail.com   
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi Recruiting
Izmir, Turkey, 35210
Contact: Site Coordinator    +90 2324116000    ceylangokhan@yahoo.com   
Erciyes University Medical Faculty Recruiting
Kayseri, Turkey, 38039
Contact: Site Coordinator    +90 5378508156 ext 25455    turkanp@erciyes.edu.tr   
Mersin University Health Research and Practice Hospital Recruiting
Mersin, Turkey, 33343
Contact: Site Coordinator    +90 5365676089    unalselma@mersin.edu.tr   
Ukraine
Regional Children's Clinical Hospital Recruiting
Dnipro, Ukraine, 49100
Contact: Site Coordinator    +380 567136311    mkaminska0307@gmail.com   
CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU Recruiting
Kharkiv, Ukraine, 61093
Contact: Site Coordinator    +380 573726061    margarytagonchar@gmail.com   
Children City Clinical Hospital Recruiting
Poltava, Ukraine, 36004
Contact: Site Coordinator    +380 532520964    ivksonz@ukr.net   
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Additional Information:
Publications:
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT02798471     History of Changes
Other Study ID Numbers: DU176b-D-U312
2016-000991-49 ( EudraCT Number )
CTRI/2018/01/011249 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Pediatric
Venous thrombolism
Pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Edoxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors