CompletedPhase 4

Apixaban for the Acute Treatment of Venous Thromboembolism in Children

United States229 participantsStarted 2015-11-22

Plain-language summary

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

Age range0 Days – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding

Timeframe: From first dose (Day 1) up to 114 days

Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality

Timeframe: From first dose (Day 1) up to 114 days

NCT IDNCT02464969

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

Results submitted2024-10-09

Who can participate

Age range0 Days – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

What they're measuring

Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding

Timeframe: From first dose (Day 1) up to 114 days

Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality

Timeframe: From first dose (Day 1) up to 114 days