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Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

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ClinicalTrials.gov Identifier: NCT03395639
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).

All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.

The study will find out if edoxaban is safer and more effective than the standard of care.


Condition or disease Intervention/treatment Phase
Cardiac Disease Drug: Edoxaban Drug: Standard of Care (SOC) Phase 3

Detailed Description:

The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis [ISTH] definition.

The key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arm Intervention/treatment
Experimental: Edoxaban
Two out of three participants will be randomized for treatment with edoxaban solution or tablets
Drug: Edoxaban
Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration
Other Names:
  • Lixiana
  • Savaysa

Active Comparator: Standard of Care (SOC)
One out of three participants will be randomized for treatment with the institution's SOC regimen
Drug: Standard of Care (SOC)
Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
Other Names:
  • Warfarin/heparin
  • Enoxaparin




Primary Outcome Measures :
  1. Number of participants with combined bleeding events within the main treatment period [ Time Frame: within 4 months (3-month Main Treatment Period + 30-day follow-up) ]
    Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period

  2. Number of participants with combined bleeding events during the entire trial (from first to the last dose plus 30 days) [ Time Frame: within 13 months (3-month Main Treatment Period + 9-month Extension Period + 30-day follow-up) ]
    Combined bleeding events include major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring on treatment


Secondary Outcome Measures :
  1. Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways [ Time Frame: within 4 months ]
    Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)

  2. Number of participants with symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways [ Time Frame: within 13 months ]
    Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI)

  3. Number of participants who died as a result of TE between randomization and the date of the last dose of study drug plus 30 days [ Time Frame: within 13 months ]
  4. Number of participants who died as a result of any cause between randomization and the date of the last dose of study drug plus 30 days [ Time Frame: within 13 months ]


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

Inclusion Criteria:

  • Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis

Either one of the following:

  1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention).

    OR

  2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE.

Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery.

  • Is a male or female child between 1 and <18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and <18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period)
  • Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative.
  • If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study

Exclusion Criteria:

  • Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period
  • Has mechanical heart valve(s)
  • Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant
  • Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related
  • Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded
  • Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk
  • Has estimated glomerular filtration rate (eGFR) <30% of normal for age and size
  • Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed >99th percentile plus 5 mmHg
  • Has thrombocytopenia or life expectancy less than three months
  • Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy
  • Is pregnant or breastfeeding
  • Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA)
  • Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol

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): NCT03395639


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Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Study Coordinator    205-638-2018    khock@peds.uab.edu   
United States, Arizona
Cardon Childrens Medical Center Recruiting
Mesa, Arizona, United States, 85202
Contact: Nurse Administrator    480-412-5561    Stephanie.Blythe@bannerhealth.com   
United States, California
Cedars Sinai Medical Center (ECG) Recruiting
Los Angeles, California, United States, 90048
Contact: Study Coordinator    424-315-2297    Jennifer.chang3@cshs.org   
University of California-San Francisco Department of Pediatrics - Hematology/Oncology Recruiting
San Francisco, California, United States, 94158
Contact: Study Coordinator    415-514-1489    Victoria.Vanderpoel@ucsf.edu   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Principal Investigator    312-563-2134    Sawsan_M_Awad@rush.edu   
United States, North Carolina
Novant Health Heart and Vascular institute Terminated
Charlotte, North Carolina, United States, 28204
East Carolina Heart Institute @ ECU Recruiting
Greenville, North Carolina, United States, 27834
Contact: Study Coordinator    252-744-2161    stanleyt18@ecu.edu   
Wake Forest University Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator    336-716-0308    snorona@wakehealth.edu   
United States, Oklahoma
OU Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Principal Investigator    405-271-4411    Charles-Sperrazza@ouhsc.edu   
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Study Coordinator    434-243-0910    crb3y@virginia.edu   
United States, Washington
Seattle Children's Research Institute Recruiting
Seattle, Washington, United States, 98105
Contact: Study Coordinator    206-987-5914    Courtney.dethlefs@seattlechildrens.org   
Austria
Kepler Universitätsklinikum Med Campus IV Recruiting
Linz, Austria, 4020
Contact: Study Coordinator    +43 576808424817    Andreas.Tulzer@kepleruniklinikum.at   
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Study Coordinator    905-521-2100 ext 76054    hamiltonko@hhsc.ca   
Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Principal Investigator    514-315-4931 ext 2152    nagib.dahdah.hsj@ssss.gouv.qc.ca   
McGill University Health Centre/Glen Site/Montreal Children's Hospital Recruiting
Pierrefonds, Quebec, Canada, H9H 4Y6
Contact: Principal Investigator    514-412-4400 ext 24445    christine.sabapathy@mcgill.ca   
Croatia
University Hospital Center Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Principal Investigator    +385 12367591    dorotea.bartonicek@gmail.com   
Egypt
Zagazig University Hospital Recruiting
Zagazig, Al Sharkeya, Egypt, 44519
Contact: Principal Investigator    +20 35840476    m_a_badr2005@yahoo.com   
Alexandria Clinical Research Center, Faculty of Medicine Recruiting
Alexandria, Egypt, 21131
Contact: Principal Investigator    +20 1227392947    drhoda@doctor.com   
Ain Shams University Hospital Recruiting
Cairo, Egypt, 11566
Contact: Principal Investigator    +20 1000864343    elalfym@hotmail.com   
France
Hôpital Des Enfants, Bâtiment Modulaire Recruiting
Toulouse cedex 9, Haute Garonne, France, 31059
Contact: Study Coordinator    +33 567771095    auriol.f@chu-toulouse.fr   
Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital Recruiting
Montpellier, Herault, France, 34295
Contact: Study Coordinator    +33 467336632    Hamouda-abassi@chu-montpellier.fr   
Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes Recruiting
Paris, Paris Cedex 15, France, 75015
Contact: Principal Investigator    +33 144494344    damien.bonnet@aphp.fr   
Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet Recruiting
Budapest, Hungary, 1096
Contact: Principal Investigator    +36 12151220    ablonczyl@gmail.com   
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Recruiting
Szeged, Hungary, 6720
Contact: Study Coordinator    +36 62545330    study.pedia@med.u-szeged.hu   
India
Nirmal Hospital Private Limited Recruiting
Sūrat, Gujarat, India, 395002
Contact: Principal Investigator    +91 9979530073    drjashvant.patel@gmail.com   
Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel, 8410101
Contact: Study Coordinator    +972 86243589    Ayeletpu@clalit.org.il   
Hadassah University Hospital - Ein Kerem Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +972 26777511    hilay@hadassah.org.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    +927 35308010    oliana.Vazhgovky@sheba.health.gov.il   
Lebanon
Children's Heart Centre at the American University of Beirut Medical Center Recruiting
Beirut, Lebanon, 11-0236
Contact: Principal Investigator    +961 1350000 ext 5865    fbitar@aub.edu.lb   
Hotel Dieu de France Hospital Recruiting
Beirut, Lebanon, 166830
Contact: Principal Investigator    +961 3434942    najibhanna@gmail.com   
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Principal Investigator    34679651335    froses@vhebron.net   
Ukraine
Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine Recruiting
Dnipro, Ukraine, 49100
Contact: Principal Investigator    +380 677671524    Vdihtiar2017@gmail.com   
Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University Recruiting
Kharkiv, Ukraine, 61093
Contact: Principal Investigator    +380 506388992    margarytagonchar@gmail.com   
United Kingdom
Royal Brompton Hospital Recruiting
London, Greater London, United Kingdom, SW3 6HP
Contact: Principal Investigator    +44 3301288430    p.daubeney@rbht.nhs.uk   
Glenfield Hospital Recruiting
Leicester, Leicestershire, United Kingdom, LE3 9QP
Contact: Principal Investigator    +44 1162563904    frances.bu'lock@uhl-tr.nhs.uk   
Ward 2B, Royal Hospital for Children Recruiting
Glasgow, Strathclyde, United Kingdom, G51 4TF
Contact: Nurse Administrator    +44 1414524624    alison.spence2@ggc.scot.nhs.uk   
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03395639     History of Changes
Other Study ID Numbers: DU176b-C-U313
2017-000475-90 ( EudraCT Number )
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 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.:
Children
Pediatrics
Cardiac disease with potential for thromboembolic complications
Prophylactic treatment
Anticoagulant drugs
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular 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