Purpose

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

Condition

Eligibility

Eligible Ages
Between 3 Months and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 28 days to <18 years of age with a minimum weight of 4 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 for at least 5 days.

Exclusion Criteria

  1. Anticoagulant treatment for the index VTE for greater than 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.)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Apixaban
Subjects between 28 days to <18 years will be dosed on a body weight tiered regimen. Subjects > or = 35 kg will receive 10 mg twice daily for 7 days followed by 5 mg twice daily thereafter;<35 kg to 25 kg will receive 8 mg twice daily for 7 days followed by 4 mg twice daily thereafter; <25 to 18 kg will receive 6 mg twice daily for 7 days and then 3mg twice daily thereafter; <18 to 12 kg will receive 4 mg twice daily for 7 days and then 2 mg twice daily thereafter; <12 to 9 kg will receive 3 mg twice daily for 7 days and then 1.5 mg twice daily thereafter; <9 kg to 6 kg will receive 2 mg twice daily for 7 days and 1 mg twice daily thereafter; <6 kg to 5 kg will receive 1 mg twice daily for 7 days and 0.5 mg twice daily thereafter; <5 kg to 4 kg will receive 0.6 mg twice daily for 7 days and 0.3 mg twice daily thereafter.
  • Drug: Apixaban
    Tablet or Solution
Active Comparator
Standard of Care
Subjects will receive a dose and dosing regimen of anticoagulation treatment based on usual and customary care per local practices.
  • Drug: 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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Vanderbilt University Medical Center
Nashville, Tennessee 37232-7610

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.