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Apixaban for the Acute Treatment of Venous Thromboembolism in Children

Last updated on November 6, 2018

FOR MORE INFORMATION
Study Location
Loma Linda University Cancer Center
Loma Linda, California, 92350 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-17
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 3 months to 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 12
weeks.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Anticoagulant treatment for the index VTE for greater than 7 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

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.

NCT02464969
Pfizer
Recruiting
Apixaban for the Acute Treatment of Venous Thromboembolism in Children

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Apixaban for the Acute Treatment of Venous Thromboembolism in Children
A Randomized, Open Label, Active Controlled, Safety And Descriptive Efficacy Study In Pediatric Subjects Requiring Anticoagulation For The Treatment Of A Venous Thromboembolic Event
To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Venous Thromboembolism
  • Drug: Apixaban
    Tablet or Solution
  • Drug: Standard of Care
    Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist.
  • Experimental: Apixaban
    Subjects between the ages of 2 to <18 years who are >=35 kg will receive 10 mg twice daily for 7 days followed by 5 mg twice daily thereafter. Subjects between the ages of 2 to <18 years who are <35 kg will receive a dose of 0.28 mg/kg twice daily for 7 days followed by 0.14 mg/kg twice daily thereafter.
    Intervention: Drug: Apixaban
  • 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.
    Intervention: Drug: Standard of Care
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
April 29, 2021
April 29, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 2 to <18 years of age at the time of consent.
  2. Presence of an index VTE which is confirmed by imaging.
  3. Intention to manage the index VTE with anticoagulation treatment for at least 12 weeks.

Exclusion Criteria:

  1. Anticoagulant treatment for the index VTE for greater than 7 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.
Sexes Eligible for Study: All
up to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Austria,   Canada,   Germany,   Russian Federation,   Ukraine,   United States
 
 
NCT02464969
B0661037
2014-002606-20 ( EudraCT Number )
BMS STUDY NUMBER CV185-325 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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