Last updated on July 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Thrombosis
  • Age: Between 2 - 8 Years
  • Gender: Male or Female

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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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