CompletedPhase 1

Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

United States, Australia, Canada49 participantsStarted 2013-01-10

Plain-language summary

CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis

Who can participate

Age range

1 Day – 18 Years

Sex

ALL

See this in plain English?

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder * Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \<18 years of age * Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age * Neonates: defined as newly born (within 4 weeks) * Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system Exclusion Criteria: * Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug * Active bleeding or high risk of bleeding * Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \[NG tube\] or gastronomy tube \[G-tube\])

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)

Maximum estimated plasma concentration (Cmax) of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)

Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)

Trial details

NCT IDNCT01707394

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More Thromboembolism trials

Who can participate

Age range

1 Day – 18 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)

Maximum estimated plasma concentration (Cmax) of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)

Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban

Timeframe: Up to 26 hours, post dose (from Day 1 to Day 2)