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 States112 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 range2 Years – 8 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.

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

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

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

Trial details

NCT IDNCT02846532

SponsorJanssen Research & Development, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-16

Results submitted2022-01-13

View on ClinicalTrials.gov More Thrombosis trials