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CompletedPhase 4

Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Key facts

Who runs it
Bristol-Myers Squibb
Where
Akron, Ann Arbor, Atlanta, Aurora, Birmingham, Boston, Charleston, Charlotte, Chicago, Cincinnati, Cleveland, Columbus, Detroit, Durham, Fargo, Gainesville, Hackensack, Hartford, Hollywood, Houston, Indianapolis, Iowa City, Jackson, Kansas City, Lexington, Loma Linda, Madera, Miami, Milwaukee, Nashville, New York, Oakland, Oklahoma City, Orlando, Palo Alto, Peoria, Philadelphia, Phoenix, Pittsburgh, Sacramento, Salt Lake City, San Antonio, San Bernardino, San Francisco, Seattle, Syracuse, Tampa, Washington D.C., West Palm Beach, and Wilmington, United StatesSee the 83 sitesAlso in 12 other countries, 44 sites
Status
Completed
Phase
Phase 4
People taking part
229 people enrolled
Started
22 Nov 2015
Ended
30 Apr 2024
Type of study
Interventional
Treatments tested
  • Apixaban
  • Standard of Care
Record updated
29 October 2024

Who can take part

Age
0 days to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization
  • Presence of an index VTE which is confirmed by imaging
  • Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks
  • Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement

Who cannot take part

  • Anticoagulant treatment for the index VTE for greater than 14 days prior to randomization. Neonates that are enrolled into the PK cohort must be on a minimum of 5 days and a maximum of 14 days SOC anticoagulation prior to randomization. Neonates that are enrolled into the post PK cohort may receive SOC anticoagulation for up to 14 days prior to randomization
  • Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE
  • Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization
  • Use of prohibited concomitant medication at the time of randomization
  • Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
  • Unable to take oral or enteric medication via the NG or G tube
  • A mechanical heart valve
  • Active bleeding or high risk of bleeding at the time of randomization
  • Uncontrolled severe hypertension at the time of randomization
  • Known inherited or acquired antiphospholipid syndrome (APS)
  • Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)
  • Platelet count <50×109 per L at randomization
  • Abnormal baseline liver function at randomization
  • Inadequate renal function at the time of randomization
  • Female subjects who are either pregnant or breastfeeding a child

Where in United States

Also in 12 other countries, 44 sites

  • Akron Children's HospitalAkron, United States
  • University of MichiganAnn Arbor, United States
  • Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research UnitAtlanta, United States
  • Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS PharmacyAtlanta, United States
  • Children's Healthcare of Atlanta-EglestonAtlanta, United States
  • Children's Hospital ColoradoAurora, United States
  • Children's Hospital Colorado- Investigational Drug ServicesAurora, United States
  • Pediatric Cardiology ClinicBirmingham, United States
  • University of AlabamaBirmingham, United States
  • Boston Children's HospitalBoston, United States
  • Medical University of South CarolinaCharleston, United States
  • Medical University of South Carolina- Investigational Drug ServicesCharleston, United States
  • Medical University of South Carolina: Shawn Jenkins Women's and Children's HospitalCharleston, United States
  • Levine Children's HospitalCharlotte, United States
  • Levine Children's Hospital, Pediatric ResearchCharlotte, United States
  • Levine Children's Specialty CenterCharlotte, United States
  • Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United States
  • Cincinnati Children's Hospital Medical CenterCincinnati, United States
  • Cleveland ClinicCleveland, United States
  • University Hospitals Cleveland Medical Center*Cleveland, United States
  • Nationwide Children's HospitalColumbus, United States
  • Children's Hospital of MichiganDetroit, United States
  • Duke University Medical CenterDurham, United States
  • Investigational Drug Service, Duke University HospitalDurham, United States
  • Sanford Children's HospitalFargo, United States
  • Sanford Roger Maris Cancer CenterFargo, United States
  • UF Health Shands HospitalGainesville, United States
  • Hackensack University Medical CenterHackensack, United States
  • Connecticut Children's Medical CenterHartford, United States
  • Connecticut Children's Medical Center PharmacyHartford, United States
  • JDCH Division of Pediatric Hematology and OncologyHollywood, United States
  • Joe DiMaggio Children's HospitalHollywood, United States
  • Memorial Regional HospitalHollywood, United States
  • Texas Children's Hospital - Main HospitalHouston, United States
  • Texas Children's Hospital - Wallace TowerHouston, United States
  • Indiana UniversityIndianapolis, United States
  • IU Health PharmacyIndianapolis, United States
  • Riley Hospital for Children at IU HealthIndianapolis, United States
  • University of Iowa Hospitals and ClinicsIowa City, United States
  • University of Mississippi Medical CenterJackson, United States
  • Children's Mercy HospitalKansas City, United States
  • University of Kentucky Medical CenterLexington, United States
  • Loma Linda University Cancer CenterLoma Linda, United States
  • Loma Linda University Children's HospitalLoma Linda, United States
  • Loma Linda University Medical CenterLoma Linda, United States
  • Valley Children's HospitalMadera, United States
  • Nicklaus Children's HospitalMiami, United States
  • Children's Hospital of WisconsinMilwaukee, United States
  • Versiti WisconsinMilwaukee, United States
  • Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United States
  • Vanderbilt University Medical CenterNashville, United States
  • Columbia University Medical CenterNew York, United States
  • New York -Presbyterian Morgan Stanley Children's HospitalNew York, United States
  • Children's Hospital and Research Center OaklandOakland, United States
  • OU Medical Center Investigational Drug PharmacyOklahoma City, United States
  • University of Oklahoma Health Sciences CenterOklahoma City, United States
  • AdventHealth OrlandoOrlando, United States
  • AdventHealth Orlando-Pharmacy Investigational Drug ServicesOrlando, United States
  • AdventHealth Pediatric Oncology Hematology at OrlandoOrlando, United States
  • Bass Speicalty PharmacyPalo Alto, United States
  • Inpatient PharmacyPalo Alto, United States
  • Lucile Packard Children's Hosptial - Stanford UniversityPalo Alto, United States
  • Bleeding and Clotting Disorders InstitutePeoria, United States
  • OSF Saint Francis Medical CenterPeoria, United States
  • Unity Point Methodist Medical CenterPeoria, United States
  • St. Christopher's Hospital for ChildrenPhiladelphia, United States
  • The Children's Hospital Of PhiladelphiaPhiladelphia, United States
  • Phoenix Children s HospitalPhoenix, United States
  • UPMC Children's Hospital of PittsburghPittsburgh, United States
  • University of California Davis Comprehensive Cancer CenterSacramento, United States
  • Primary Children's HospitalSalt Lake City, United States
  • The Children's Hospital of San AntonioSan Antonio, United States
  • University of Texas Health - San AntonioSan Antonio, United States
  • Loma Linda University Health CareSan Bernardino, United States
  • UCSF Benioff Children's HospitalSan Francisco, United States
  • UCSF Mission Bay Pediatric Clinical Research CenterSan Francisco, United States
  • Seattle Children's HospitalSeattle, United States
  • SUNY Upstate Medical UniversitySyracuse, United States
  • St. Joseph's HospitalTampa, United States
  • Childrens National Medical CenterWashington D.C., United States
  • Children's Hematology and Oncology a division of Kidz medical ServiceWest Palm Beach, United States
  • St. Mary's Medical CenterWest Palm Beach, United States
  • Nemours/Alfred I. duPont Hospital for ChildrenWilmington, United States

About the trial

What the trial wants to find out

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

The group in the trial

  • ApixabanTreatment being tested

    Subjects between birth to \<18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;\<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;\<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;\<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;\<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;\< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;\<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;\<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.

    Treatment: Apixaban and Standard of Care

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
Publications
Record updated
29 October 2024