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

Primary Purpose

Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Standard of Care
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism (VTE) focused on measuring Pediatric, Venous thrombolism, Pulmonary embolism

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner University Medical Center
  • Children's Hospital Los Angeles
  • UCLA Medical Center CAR
  • Stanford University Medical Center
  • University of Miami Miller School of Medicine
  • University of South Florida
  • Rush University Medical Center
  • Advocate Children's Hospital-Oak Lawn
  • Indiana Hemophilia and Thrombosis Center
  • University of Louisville
  • Spectrum Health Helen DeVos Children's Hospital Grand Rapids
  • Children's Hospital & Clinics of Minnesota
  • Washington University School of Medicine
  • University North Carolina- Chapel Hill
  • Levine Children's Hospital Charlotte
  • The Presbyterian Hospital
  • East Carolina University
  • University of Oklahoma Health Sciences Center
  • Hasbro Children's Hospital
  • Le Bonheur Childrens Hospital
  • St. Jude Children's Research Hospital
  • Children's Hospital of Wisconsin
  • Hospital Italiano Regional del Sur
  • Sanatorio Allende
  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira
  • Hospital São Vicente de Paulo
  • Hospital da Cidade de Passo Fundo
  • Instituto de Cardiologia do Rio Grande do Sul
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC
  • Santa Casa de Votuporanga
  • Hospital Samaritano
  • Hospital da Luz Amico Saude LTDA
  • Hospital Infantil Pequeno Príncipe
  • GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer
  • UNIFESP - Universidade Federal de São Paulo
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • HMCG - Hospital e Maternidade Dr. Christovão da Gama
  • UMHAT "Sv. Georgi", EAD
  • MHAT - "National Heart Hospital" EAD
  • MHAT 'Tokuda Hospital Sofia', EAD
  • Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases
  • Edmonton Clinic Health Academy
  • CancerCare Manitoba
  • McMaster Children's Hospital
  • Hospital El Carmen Dr. Luis Valentin Ferrada
  • Clinica Las Condes
  • Clinical Hospital Centre Rijeka
  • General Hospital Zadar
  • Children's Hospital Zagreb
  • University Hospital Centre Zagreb, University of Zagreb School of Medicine
  • Fakultni nemocnice Brno
  • CTC Hodonin s.r.o.
  • Dětská klinika Fakultní nemocnice
  • University Hospital Pilsen, CZ
  • Ålborg Universitetshospital
  • Hospital Nacional de Niños Benjamín Bloom
  • Clinical Hospital Centre Cavale Blanche BREST
  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque
  • Hôpital des enfants, CHU Toulouse
  • CHU Rennes - Hopital Sud
  • CHU Angers - Hôpital Hôtel Dieu
  • CHU Clermont Ferrand - Hôpital d'Estaing
  • CHU Arnaud de Villeneuve
  • Universitaetsklinikum Essen
  • Charite - Campus Virchow-Klinikum
  • Unidad de Cirugía Cardiovascular de Guatemala (UNICAR)
  • Unidad Nacional de Oncología Pediátrica (UNOP)
  • Semmelweis University 2nd Department of Pediatrics
  • Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases
  • Debreceni Egyetem Klinikai Kozpont
  • University of Szeged, Department of Pediatrics
  • Sir Ganga Ram Hospital
  • Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education
  • Nirmal Hospital
  • Jain Institute of Vascular Sciences
  • M. S. Ramaiah Medical College and Hospital
  • Government Medical College and Hospital
  • Christian Medical College
  • Institute of Child Health
  • Indraprastha Apollo Hospitals
  • Rambam Medical Center
  • Shaare Zedek Medical Center
  • Hadassah ein Kerem
  • Chaim Sheba Medical Center
  • Strathmore University Medical Centre
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University
  • Samsung Medical Center
  • American University of Beirut Medical Center
  • Saint George University Hospital Medical Center
  • Hotel Dieu de France Hospital
  • Hospital Raja Perempuan Zainab II
  • Erasmus MC Sophia
  • Oslo University Hospital
  • INDICASAT AIP Site 7871
  • INDICASAT AIP Site 7872
  • Hospital de Braga
  • Hospital da Senhora da Oliveira
  • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta
  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  • S.C Centrul Clinic Mediquest S.R.L
  • FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA"
  • Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology
  • Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic"
  • Clinical Center Kragujevac
  • National University Hospital
  • KK Women's And Children's Hospital
  • University Medical Centre Ljubljana
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Araba
  • Buddhist Tzu Chi General Hospital
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Taipei Medical University Hospital
  • Ramathibodi Hospital
  • King Chulalongkorn Memorial Hospital
  • Phramongkutklao Hospital
  • Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
  • Srinagarind Hospital
  • Songklanagarind Hospital
  • Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department
  • Hacettepe University Medical Faculty
  • Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi
  • Istanbul University Istanbul Medical Faculty
  • Yeditepe University Oncology Hospital
  • Ege University Medical Faculty
  • Izmir Tepecik Training and Research Hospital
  • Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Erciyes University Medical Faculty
  • Mersin University Health Research and Practice Hospital
  • Regional Children's Clinical Hospital
  • CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU
  • Children City Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Edoxaban

Standard of Care

Arm Description

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.

Standard of Care (SOC) treatment will be dispensed to the participant on a monthly visit schedule.

Outcomes

Primary Outcome Measures

Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (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.
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
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. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).

Secondary Outcome Measures

Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (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.
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Diagnosis of recurrent venous thromboembolism (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.
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications.
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning.
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events.
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).

Full Information

First Posted
May 11, 2016
Last Updated
February 3, 2023
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02798471
Brief Title
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
Keywords
Pediatric, Venous thrombolism, Pulmonary embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Experimental
Arm Description
Standard of Care (SOC) treatment will be dispensed to the participant on a monthly visit schedule.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Warfarin/heparin, Enoxaparin, Fondaparinux
Intervention Description
Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
Primary Outcome Measure Information:
Title
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Diagnosis of recurrent venous thromboembolism (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.
Time Frame
Randomization to Month 3
Title
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time Frame
Randomization to Month 3
Title
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
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. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time Frame
Randomization to Month 3
Secondary Outcome Measure Information:
Title
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Diagnosis of recurrent venous thromboembolism (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.
Time Frame
From randomization up to Month 12
Title
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Description
Diagnosis of recurrent venous thromboembolism (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.
Time Frame
Randomization to Month 3
Title
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time Frame
From randomization up to Month 12
Title
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Description
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time Frame
Randomization to Month 3
Title
Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time Frame
From randomization up to Month 12
Title
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Description
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time Frame
Randomization to Month 3
Title
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Description
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications.
Time Frame
From randomization up to Month 12
Title
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Description
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning.
Time Frame
From randomization up to Month 12
Title
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Time Frame
Randomization to Month 3
Title
Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events.
Time Frame
From randomization up to Month 12
Title
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Description
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Time Frame
From randomization up to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Pediatric subjects with the presence of documented VTE confirmed by appropriate diagnostic imaging and requiring anticoagulant therapy for at least 90 days. 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. 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. 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: 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). Subjects who have been or are being treated with thrombolytic agents, thrombectomy or insertion of a caval filter for the newly identified index VTE. 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. Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded. 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. Subjects with glomerular filtration rate (GFR) < 30% of normal for age and size as determined by the Schwartz formula. Subjects with stage 2 hypertension defined as blood pressure (BP) systolic and/or diastolic confirmed > 99th percentile + 5 mmHg. 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. Life expectancy less than the expected study treatment duration (3 months). Subjects who are known to be pregnant or breastfeeding. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCLA Medical Center CAR
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Children's Hospital-Oak Lawn
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2699
Country
United States
Facility Name
Indiana Hemophilia and Thrombosis Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Spectrum Health Helen DeVos Children's Hospital Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Children's Hospital & Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University North Carolina- Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Levine Children's Hospital Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Le Bonheur Childrens Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-4874
Country
United States
Facility Name
Hospital Italiano Regional del Sur
City
Buenos Aires
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
City
Pernambuco
State/Province
Recife
ZIP/Postal Code
50070-550
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Pôrto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90620-001
Country
Brazil
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09190-510
Country
Brazil
Facility Name
Santa Casa de Votuporanga
City
Votuporanga
State/Province
São Paulo
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
Hospital Samaritano
City
São Paulo
ZIP/Postal Code
01232-010
Country
Brazil
Facility Name
Hospital da Luz Amico Saude LTDA
City
São Paulo
ZIP/Postal Code
04013-060
Country
Brazil
Facility Name
Hospital Infantil Pequeno Príncipe
City
São Paulo
ZIP/Postal Code
04013-060
Country
Brazil
Facility Name
GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer
City
São Paulo
ZIP/Postal Code
04039-001
Country
Brazil
Facility Name
UNIFESP - Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04039-032
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
HMCG - Hospital e Maternidade Dr. Christovão da Gama
City
São Paulo
ZIP/Postal Code
09030-010
Country
Brazil
Facility Name
UMHAT "Sv. Georgi", EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT - "National Heart Hospital" EAD
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
MHAT 'Tokuda Hospital Sofia', EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Edmonton Clinic Health Academy
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Hospital El Carmen Dr. Luis Valentin Ferrada
City
Maipu
ZIP/Postal Code
9251521
Country
Chile
Facility Name
Clinica Las Condes
City
Santiago
ZIP/Postal Code
7591047
Country
Chile
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
General Hospital Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Children's Hospital Zagreb
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
University Hospital Centre Zagreb, University of Zagreb School of Medicine
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
CTC Hodonin s.r.o.
City
Hodonin
ZIP/Postal Code
69501
Country
Czechia
Facility Name
Dětská klinika Fakultní nemocnice
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Pilsen, CZ
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Ålborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Hospital Nacional de Niños Benjamín Bloom
City
San Salvador
State/Province
Salvador
Country
El Salvador
Facility Name
Clinical Hospital Centre Cavale Blanche BREST
City
Brest
State/Province
Finistere
ZIP/Postal Code
29200
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Lévêque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33600
Country
France
Facility Name
Hôpital des enfants, CHU Toulouse
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Rennes - Hopital Sud
City
Rennes
State/Province
Ille Et Vilaine
ZIP/Postal Code
35203
Country
France
Facility Name
CHU Angers - Hôpital Hôtel Dieu
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
CHU Clermont Ferrand - Hôpital d'Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Universitaetsklinikum Essen
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Charite - Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Unidad de Cirugía Cardiovascular de Guatemala (UNICAR)
City
Guatemala
Country
Guatemala
Facility Name
Unidad Nacional de Oncología Pediátrica (UNOP)
City
Guatemala
Country
Guatemala
Facility Name
Semmelweis University 2nd Department of Pediatrics
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
University of Szeged, Department of Pediatrics
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education
City
Karamsad
State/Province
Gujarat
ZIP/Postal Code
388325
Country
India
Facility Name
Nirmal Hospital
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Jain Institute of Vascular Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
M. S. Ramaiah Medical College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Government Medical College and Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Christian Medical College
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Institute of Child Health
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700017
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Strathmore University Medical Centre
City
Nairobi
ZIP/Postal Code
59857-00200
Country
Kenya
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
American University of Beirut Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Facility Name
Saint George University Hospital Medical Center
City
Beirut
ZIP/Postal Code
166378
Country
Lebanon
Facility Name
Hotel Dieu de France Hospital
City
Beirut
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Erasmus MC Sophia
City
Rotterdam
ZIP/Postal Code
3000 CB
Country
Netherlands
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
15-274
Country
Norway
Facility Name
INDICASAT AIP Site 7871
City
Panamá
ZIP/Postal Code
0843-01103
Country
Panama
Facility Name
INDICASAT AIP Site 7872
City
Panamá
ZIP/Postal Code
0843-01103
Country
Panama
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital da Senhora da Oliveira
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta
City
Lisboa
ZIP/Postal Code
1169-1024
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
S.C Centrul Clinic Mediquest S.R.L
City
Sângeorgiu De Mureş
ZIP/Postal Code
547530
Country
Romania
Facility Name
FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA"
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic"
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
KK Women's And Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Araba
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei City
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi
City
Ankara
ZIP/Postal Code
6110
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Yeditepe University Oncology Hospital
City
Istanbul
ZIP/Postal Code
34718
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
ZIP/Postal Code
35170
Country
Turkey
Facility Name
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
City
Izmir
ZIP/Postal Code
35210
Country
Turkey
Facility Name
Erciyes University Medical Faculty
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Mersin University Health Research and Practice Hospital
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Regional Children's Clinical Hospital
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU
City
Kharkiv
ZIP/Postal Code
61093
Country
Ukraine
Facility Name
Children City Clinical Hospital
City
Poltava
ZIP/Postal Code
36004
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
23991658
Citation
Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Jan 23;370(4):390.
Results Reference
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Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

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