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

PHASE3CompletedINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

May 24, 2022

Study Completion Date

May 24, 2022

Conditions
Venous Thromboembolism (VTE)Pulmonary EmbolismDeep Vein Thrombosis (DVT)
Interventions
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

DRUG

Standard of Care

Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.

Trial Locations (140)

970

Buddhist Tzu Chi General Hospital, Hualien City

1000

University Medical Centre Ljubljana, Ljubljana

1094

Semmelweis University 2nd Department of Pediatrics, Budapest

1309

"MHAT - National Heart Hospital EAD", Sofia

1330

Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department, Adana

1407

MHAT 'Tokuda Hospital Sofia', EAD, Sofia

1612

Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases, Sofia

3080

Seoul National University Hospital, Seoul

3722

Severance Hospital, Yonsei University, Seoul

4000

"UMHAT Sv. Georgi, EAD", Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

6100

Hacettepe University Medical Faculty, Ankara

6110

Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi, Ankara

6351

Samsung Medical Center, Seoul

6720

University of Szeged, Department of Pediatrics, Szeged

8035

Hospital Universitari Vall d'Hebron, Barcelona

9000

Ålborg Universitetshospital, Aalborg

10000

University Hospital Centre Zagreb, University of Zagreb School of Medicine, Zagreb

10300

Ramathibodi Hospital, Bangkok

10330

King Chulalongkorn Memorial Hospital, Bangkok

10400

Phramongkutklao Hospital, Bangkok

11031

Taipei Medical University Hospital, Taipei

11070

"Mother and Child Health Care Institute of Serbia Dr. Vukan Cupic", Belgrade

13353

Charite - Campus Virchow-Klinikum, Berlin

13620

Seoul National University Bundang Hospital, Seongnam-si

15586

Hospital Raja Perempuan Zainab II, Kota Bharu

23000

General Hospital Zadar, Zadar

27517

University North Carolina- Chapel Hill, Chapel Hill

27858

East Carolina University, Greenville

28046

Hospital Universitario La Paz, Madrid

28204

Levine Children's Hospital Charlotte, Charlotte

28210

The Presbyterian Hospital, Charlotte

29200

Clinical Hospital Centre Cavale Blanche BREST, Brest

31059

Hôpital des enfants, CHU Toulouse, Toulouse

33136

University of Miami Miller School of Medicine, Miami

33343

Mersin University Health Research and Practice Hospital, Mersin

33600

Groupe Hospitalier Sud - Hôpital Haut-Lévêque, Pessac

33606

University of South Florida, Tampa

34000

Clinical Center Kragujevac, Kragujevac

34093

Istanbul University Istanbul Medical Faculty, Istanbul

34295

CHU Arnaud de Villeneuve, Montpellier

34718

Yeditepe University Oncology Hospital, Istanbul

35040

Ege University Medical Faculty, Izmir

35170

Izmir Tepecik Training and Research Hospital, Izmir

35203

CHU Rennes - Hopital Sud, Rennes

35210

Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi, Izmir

36004

Children City Clinical Hospital, Poltava

38039

Erciyes University Medical Faculty, Kayseri

38105

Le Bonheur Childrens Hospital, Memphis

St. Jude Children's Research Hospital, Memphis

40002

Srinagarind Hospital, Khon Kaen

40202

University of Louisville, Louisville

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

45122

Universitaetsklinikum Essen, Essen

46260

Indiana Hemophilia and Thrombosis Center, Indianapolis

49100

CHU Angers - Hôpital Hôtel Dieu, Angers

Regional Children's Clinical Hospital, Dnipro

49503

Spectrum Health Helen DeVos Children's Hospital Grand Rapids, Grand Rapids

50200

Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai

51000

Clinical Hospital Centre Rijeka, Rijeka

52621

Chaim Sheba Medical Center, Ramat Gan

53226

Children's Hospital of Wisconsin, Milwaukee

55404

Children's Hospital & Clinics of Minnesota, Minneapolis

60453

Advocate Children's Hospital-Oak Lawn, Oak Lawn

60612

Rush University Medical Center, Chicago

61093

CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU, Kharkiv

63003

CHU Clermont Ferrand - Hôpital d'Estaing, Clermont-Ferrand

63110

Washington University School of Medicine, St Louis

69501

CTC Hodonin s.r.o., Hodonín

73104

University of Oklahoma Health Sciences Center, Oklahoma City

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

85724

Banner University Medical Center, Tucson

90027

Children's Hospital Los Angeles, Los Angeles

90095

UCLA Medical Center CAR, Los Angeles

90110

Songklanagarind Hospital, Songkhla

91120

Hadassah ein Kerem, Jerusalem

94305

Stanford University Medical Center, Stanford

110060

Sir Ganga Ram Hospital, New Delhi

110076

Indraprastha Apollo Hospitals, Delhi

117997

Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology, Moscow

119074

National University Hospital, Singapore

141008

Christian Medical College, Ludhiana

166378

Saint George University Hospital Medical Center, Beirut

166830

Hotel Dieu de France Hospital, Beirut

229899

KK Women's And Children's Hospital, Singapore

388325

Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education, Karamsad

395002

Nirmal Hospital, Surat

440003

Government Medical College and Hospital, Nagpur

547530

S.C Centrul Clinic Mediquest S.R.L, Sângeorgiu de Mureş

560052

Jain Institute of Vascular Sciences, Bangalore

560054

M. S. Ramaiah Medical College and Hospital, Bangalore

610027

"FSBI of Science Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA", Kirov

700017

Institute of Child Health, Kolkata

3109601

Rambam Medical Center, Haifa

7591047

Clinica Las Condes, Santiago

9103102

Shaare Zedek Medical Center, Jerusalem

9251521

Hospital El Carmen Dr. Luis Valentin Ferrada, Maipú

02903

Hasbro Children's Hospital, Providence

B8001HXM

Hospital Italiano Regional del Sur, Buenos Aires

X5000JHQ

Sanatorio Allende, Córdoba

81520-060

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer, Curitiba

50070-550

IMIP - Instituto de Medicina Integral Professor Fernando Figueira, Pernambuco

99010-080

Hospital São Vicente de Paulo, Passo Fundo

99010-260

Hospital da Cidade de Passo Fundo, Passo Fundo

90620-001

Instituto de Cardiologia do Rio Grande do Sul, Pôrto Alegre

14784-400

Hospital de Câncer de Barretos - Fundação Pio XII, Barretos

13083-878

Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP, Campinas

09190-510

Centro Multidisciplinar de Estudos Clínicos - CEMEC, Santo André

15500-003

Santa Casa de Votuporanga, Votuporanga

01232-010

Hospital Samaritano, São Paulo

04013-060

Hospital da Luz Amico Saude LTDA, São Paulo

Hospital Infantil Pequeno Príncipe, São Paulo

04039-001

GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer, São Paulo

04039-032

UNIFESP - Universidade Federal de São Paulo, São Paulo

05403-000

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

09030-010

HMCG - Hospital e Maternidade Dr. Christovão da Gama, São Paulo

T6G 2B7

Edmonton Clinic Health Academy, Edmonton

R3E 0V9

CancerCare Manitoba, Winnipeg

L8N 3Z5

McMaster Children's Hospital, Hamilton

10 000

Children's Hospital Zagreb, Zagreb

613 00

Fakultni nemocnice Brno, Brno

500 05

Dětská klinika Fakultní nemocnice, Hradec Králové

305 99

University Hospital Pilsen, CZ, Pilsen

Unknown

Hospital Nacional de Niños Benjamín Bloom, San Salvador

Unidad de Cirugía Cardiovascular de Guatemala (UNICAR), Guatemala City

Unidad Nacional de Oncología Pediátrica (UNOP), Guatemala City

H-1097

Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Budapest

59857-00200

Strathmore University Medical Centre, Nairobi

1107 2020

American University of Beirut Medical Center, Beirut

3000 CB

Erasmus MC Sophia, Rotterdam

15-274

Oslo University Hospital, Oslo

0843-01103

INDICASAT AIP Site 7871, Panama City

INDICASAT AIP Site 7872, Panama City

4710-243

Hospital de Braga, Braga

4835-044

Hospital da Senhora da Oliveira, Guimarães

1169-1024

Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

01009

Hospital Universitario Araba, Vitoria-Gasteiz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY

NCT02798471 - Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE) | Biotech Hunter | Biotech Hunter