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

Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.