CompletedPhase 3

Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

United States, Argentina, Belgium112 participantsStarted 2016-11-16

Plain-language summary

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \[mg\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \[mg/kg\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

Who can participate

Age range

2 Years – 8 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.

Inclusion Criteria: * Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings * Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol * Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements Exclusion Criteria: * Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study * History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption * History of or signs/symptoms suggestive of protein-losing enteropathy * Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding * Platelet count less than (\<)50\*10\^9/Liters (L) at Screening * Estimated glomerular filtration rate (eGFR) \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) * Known clinically significant liver disease

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

Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)

Timeframe: Up to 12 months

Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)

Timeframe: Day 1: 0.5-1.5 hours postdose

Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)

Timeframe: Day 1: 1.5-4 hours postdose

Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)

Timeframe: Day 4: Up to 3 hours predose

Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)

Timeframe: Day 4: 0.5-1.5 hours postdose

Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)

Timeframe: Day 4: 1.5-4 hours postdose

Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)

Timeframe: Day 4: 6-8 hours postdose

Trial details

NCT IDNCT02846532

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-16

Results submitted2022-01-13

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