Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464969
• Other study ID #: B0661037
• Secondary ID: 2014-002606-20CV
• Status: Completed
• Phase: Phase 4
• Start date: November 22, 2015
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 17 Years

Eligibility

Inclusion Criteria:

1. Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization.

2. Presence of an index VTE which is confirmed by imaging.

3. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.

4. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.

Exclusion Criteria:

1. 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.

2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.

3. A mechanical heart valve.

4. Active bleeding or high risk of bleeding at the time of randomization.

5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.

6. Abnormal baseline liver function at randomization.

7. Inadequate renal function at the time of randomization.

8. Platelet count <50×109 per L at randomization.

9. Uncontrolled severe hypertension at the time of randomization.

10. Use of prohibited concomitant medication at the time of randomization.

11. Female subjects who are either pregnant or breastfeeding a child.

12. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.

13. Unable to take oral or enteric medication via the NG or G tube.

14. Known inherited or acquired antiphospholipid syndrome (APS).

15. Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban
Tablet or Solution
• Standard of Care
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.

Locations

Country	Name	City	State
Australia	The Royal Childrens Hospital	Parkville	Victoria
Australia	Kids Cancer Centre	Randwick	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Austria	A.o.Landeskrankenhaus Innsbruck	Innsbruck	Tyrol
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Medizinische Universitaet Wien	Wien
Canada	Kaye Edmonton Clinic	Edmonton	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Hamilton Health Science Corporation/McMaster Children's Hospital	Hamilton	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	The Hospital For Sick Children	Toronto	Ontario
France	Hopital de la Timone Enfants	Marseille
France	CHRU de Montpellier - Hopital Arnaud de Villeneuve	Montpellier Cedex 5
France	Hopital Necker-Enfants malades	Paris
France	CHU de Bordeaux - Hopital Haut-Leveque	PESSAC Cedex
France	Service d'Imagerie Medicale du Pr F. Laurent	PESSAC Cedex
Germany	Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)	Berlin
Germany	Universitätsklinikum Essen	Essen
Germany	Technische Universitat, Deutsches Herzzentrum Munchen	Munchen
Israel	Hadassah Medical Center (Ein Kerem)	Jerusalem
Mexico	O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Instituto Nacional De Cardiologia Ignacio Chavez	Mexico City
Russian Federation	State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of	Kazan	Republic Tatarstan
Russian Federation	FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia	Moscow
Russian Federation	State Autonomous Healthcare Institution of Sverdlovsk Region	Yekaterinburg	Sverdlovsk Region
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Turkey	Ankara City Hospital Pediatric Hematology and Oncology Clinic	Ankara
Turkey	Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital	Ankara
Turkey	Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD	Bahcelievler	Ankara
Turkey	Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali	Izmir
Turkey	Adana Acibadem Hospital	Seyhan	Adana
Ukraine	Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child	Dnipro
Ukraine	Dnipropetrovsk Regional Children's Hospital	Dnipro
Ukraine	Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"	Dnipro
Ukraine	Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"	Zaporizhzhia
United Kingdom	Birmingham Children's Hospital NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	Cardiff & Vale NHS Health Board	Cardiff	Wales
United Kingdom	Noah's Ark Children's Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Children	Glasgow	Scotland
United Kingdom	Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	Tyne & Wear
United States	Akron Children's Hospital	Akron	Ohio
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit	Atlanta	Georgia
United States	Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy	Atlanta	Georgia
United States	Children's Healthcare of Atlanta-Egleston	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's Hospital Colorado - Investigational Drug Services	Aurora	Colorado
United States	Pediatric Cardiology Clinic	Birmingham	Alabama
United States	University of Alabama	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina: Investigational Drug Services	Charleston	South Carolina
United States	Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	Levine Children's Hospital, Pediatric Research	Charlotte	North Carolina
United States	Levine Children's Specialty Center	Charlotte	North Carolina
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Investigational Drug Service, Duke University Hospital	Durham	North Carolina
United States	Sanford Children's Hospital	Fargo	North Dakota
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	UF Health Shands Hospital	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Connecticut Children's Medical Center Pharmacy	Hartford	Connecticut
United States	JDCH Division of Pediatric Hematology and Oncology	Hollywood	Florida
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Texas Children's Hospital- Main Hospital	Houston	Texas
United States	Texas Children's Hospital- Wallace Tower	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	IU Health Pharmacy	Indianapolis	Indiana
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	Loma Linda University Children's Hospital	Loma Linda	California
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Valley Children's Hospital	Madera	California
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Versiti Wisconsin	Milwaukee	Wisconsin
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	New York-Presbyterian Morgan Stanley Children's Hospital	New York	New York
United States	Children's Hospital and Research Center Oakland	Oakland	California
United States	OU Medical Center Investigational Drug Pharmacy	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	AdventHealth Orlando	Orlando	Florida
United States	AdventHealth Orlando-Pharmacy Investigational Drug Services	Orlando	Florida
United States	AdventHealth Pediatric Oncology Hematology at Orlando	Orlando	Florida
United States	Bass Speicalty Pharmacy	Palo Alto	California
United States	Inpatient Pharmacy	Palo Alto	California
United States	Lucile Packard Children's Hosptial - Stanford University	Palo Alto	California
United States	Bleeding and Clotting Disorders Institute	Peoria	Illinois
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Unity Point Methodist Medical Center	Peoria	Illinois
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	The Children's Hospital of San Antonio	San Antonio	Texas
United States	University of Texas Health San Antonio	San Antonio	Texas
United States	Loma Linda University Health Care	San Bernardino	California
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	UCSF Mission Bay Pediatric Clinical Research Center	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York
United States	St. Joseph's Hospital	Tampa	Florida
United States	Childrens National Medical Center	Washington	District of Columbia
United States	Children's Hematology and Oncology a division of Kidz medical Service	West Palm Beach	Florida
United States	St. Mary's Medical Center	West Palm Beach	Florida
United States	Nemours/ Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Israel,  Mexico,  Russian Federation,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of major and clinically relevant non major bleeding.	The composite of major and clinically relevant non major bleeding.	up to 12 weeks
Primary	A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.	A composite of all image confirmed and adjudicated symptomatic and asymptomatic recurrent VTE and VTE related mortality.	up to 12 weeks
Secondary	Apixaban concentration	Apixaban concentration	Day 14
Secondary	Anti-Xa Levels	Anti-Xa Levels	Day 14

External Links

•   To obtain contact information for a study center near you, click here.