Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Venous Thromboembolism
About this trial
This is an interventional treatment trial for Venous Thromboembolism focused on measuring VTE, thromboembolism, thrombosis, embolism, apixaban, Eliquis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- A mechanical heart valve.
- Active bleeding or high risk of bleeding at the time of randomization.
- Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
- Abnormal baseline liver function at randomization.
- Inadequate renal function at the time of randomization.
- Platelet count <50×109 per L at randomization.
- Uncontrolled severe hypertension at the time of randomization.
- Use of prohibited concomitant medication at the time of randomization.
- Female subjects who are either pregnant or breastfeeding a child.
- 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.
- Known inherited or acquired antiphospholipid syndrome (APS).
- Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)
Sites / Locations
- Pediatric Cardiology ClinicRecruiting
- University of AlabamaRecruiting
- Phoenix Children's Hospital
- Loma Linda University Cancer Center
- Loma Linda University Children's Hospital
- Loma Linda University Medical Center
- Valley Children's Hospital
- Children's Hospital and Research Center Oakland
- Bass Speicalty PharmacyRecruiting
- Inpatient PharmacyRecruiting
- Lucile Packard Children's Hosptial - Stanford UniversityRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Loma Linda University Health Care
- UCSF Benioff Children's HospitalRecruiting
- UCSF Mission Bay Pediatric Clinical Research CenterRecruiting
- Children's Hospital Colorado - Investigational Drug Services
- Children's Hospital Colorado
- Connecticut Children's Medical Center Pharmacy
- Connecticut Children's Medical Center
- Nemours/ Alfred I. duPont Hospital for ChildrenRecruiting
- Childrens National Medical Center
- UF Health Shands Hospital
- JDCH Division of Pediatric Hematology and Oncology
- Joe DiMaggio Children's Hospital
- Memorial Regional Hospital
- Nicklaus Children's Hospital
- AdventHealth Orlando
- AdventHealth Orlando-Pharmacy Investigational Drug Services
- AdventHealth Pediatric Oncology Hematology at Orlando
- St. Joseph's HospitalRecruiting
- Children's Hematology and Oncology a division of Kidz medical Service
- St. Mary's Medical Center
- Children's Healthcare of Atlanta-EglestonRecruiting
- Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research UnitRecruiting
- Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS PharmacyRecruiting
- Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
- Bleeding and Clotting Disorders Institute
- Unity Point Methodist Medical Center
- OSF Saint Francis Medical Center
- Indiana University
- IU Health Pharmacy
- Riley Hospital for Children at IU Health
- University of Iowa Hospitals and ClinicsRecruiting
- University of Kentucky Medical CenterRecruiting
- Boston Children's HospitalRecruiting
- University of Michigan
- Children's Hospital of MichiganRecruiting
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Hackensack University Medical Center
- Columbia University Medical Center
- New York-Presbyterian Morgan Stanley Children's Hospital
- SUNY Upstate Medical University
- Levine Children's Specialty Center
- Levine Children's Hospital, Pediatric Research
- Levine Children's Hospital
- Duke University Medical CenterRecruiting
- Investigational Drug Service, Duke University HospitalRecruiting
- Sanford Children's Hospital
- Sanford Roger Maris Cancer Center
- Akron Children's HospitalRecruiting
- Cincinnati Children's Hospital Medical Center
- University Hospitals Cleveland Medical CenterRecruiting
- Cleveland Clinic
- Nationwide Children's Hospital
- OU Medical Center Investigational Drug Pharmacy
- University of Oklahoma Health Sciences Center
- The Children's Hospital of PhiladelphiaRecruiting
- St. Christopher's Hospital for Children
- UPMC Children's Hospital of PittsburghRecruiting
- Medical University of South Carolina: Investigational Drug ServicesRecruiting
- Medical University of South Carolina: Shawn Jenkins Women's and Children's HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Vanderbilt University Medical CenterRecruiting
- Monroe Carell Jr. Children's Hospital at VanderbiltRecruiting
- Vanderbilt University Medical CenterRecruiting
- Texas Children's Hospital- Main Hospital
- Texas Children's Hospital- Wallace Tower
- The Children's Hospital of San Antonio
- University of Texas Health San Antonio
- Primary Children's Hospital
- Seattle Children's HospitalRecruiting
- Children's Hospital of Wisconsin
- Versiti Wisconsin
- Kids Cancer CentreRecruiting
- Prince of Wales HospitalRecruiting
- The Royal Childrens Hospital
- A.o.Landeskrankenhaus Innsbruck
- Medizinische Universitaet Innsbruck
- Medizinische Universitaet WienRecruiting
- Kaye Edmonton Clinic
- Stollery Children's Hospital
- Hamilton Health Science Corporation/McMaster Children's HospitalRecruiting
- The Hospital For Sick ChildrenRecruiting
- CHU Sainte-Justine
- Hopital de la Timone Enfants
- CHRU de Montpellier - Hopital Arnaud de Villeneuve
- Hopital Necker-Enfants maladesRecruiting
- CHU de Bordeaux - Hopital Haut-Leveque
- Service d'Imagerie Medicale du Pr F. Laurent
- Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)Recruiting
- Universitätsklinikum EssenRecruiting
- Technische Universitat, Deutsches Herzzentrum MunchenRecruiting
- Hadassah Medical Center (Ein Kerem)
- O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde
- Instituto Nacional De Cardiologia Ignacio Chavez
- State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of
- State Autonomous Healthcare Institution of Sverdlovsk Region
- FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia
- Hospital Sant Joan de DeuRecruiting
- Hospital Universitario HM MonteprincipeRecruiting
- Hospital Universitario Vall d´Hebron
- Hospital Universitario La PazRecruiting
- Adana Acibadem Hospital
- Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD
- Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's HospitalRecruiting
- Ankara City Hospital Pediatric Hematology and Oncology Clinic
- Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali
- Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child
- Dnipropetrovsk Regional Children's Hospital
- Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"
- Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"
- Royal Hospital for ChildrenRecruiting
- Newcastle Upon Tyne Hospitals NHS Foundation Trust
- Cardiff & Vale NHS Health BoardRecruiting
- Noah's Ark Children's Hospital for WalesRecruiting
- Birmingham Children's Hospital NHS Foundation Trust
- Birmingham Women's and Children's NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
Apixaban
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.