Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
Condition: Thrombosis
MeSH terms: Thrombosis
Intervention: Rivaroxaban; Acetylsalicylic Acid
Intervention description: Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.; Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
Intervention MeSH terms: Aspirin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 2 Years
Maximum age: 8 Years
Healthy volunteers: No
Keywords: Thromboembolism; Fontan Procedure; Children

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.
    

Eligibility criteria:

        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