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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 July 2021
• Main ID: NCT02846532
• Date of registration: 25/07/2016
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure UNIVERSE
• Scientific title: A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure
• Date of first enrolment: November 16, 2016
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02846532
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Brazil, Canada, France, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Spain, Thailand, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 8 Years
Gender: All

Health Condition(s) or Problem(s) studied

Thrombosis

Intervention(s)

Drug: Rivaroxaban

Drug: Acetylsalicylic Acid

Primary Outcome(s)

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Up to Month 12]

Area Under the Analyte ConcentrationTime Curve From Time 0 to 24 Hours (AUC24) [Time Frame: Up to Month 12]

Minimum Plasma Concentration (Cmin,ss) at Steady State [Time Frame: Up to Month 12]

Absolute Prothrombin Time (PT) [Time Frame: Up to Month 12]

Maximum Plasma Concentration (Cmax,ss) at Steady State [Time Frame: Up to Month 12]

Activated Partial Thromboplastin Time (aPTT) [Time Frame: Up to Month 12]

Number of Participants With Major Bleeding Events [Time Frame: Up to Month 12]

Anti-Factor Xa (FXa) [Time Frame: Up to Month 12]

Number of Participants With Incidence of Thrombotic Events [Time Frame: Up to Month 12]

Secondary Outcome(s)

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Time Frame: For the duration of the study, average 13 months]

Number of Participants With Clinically Relevant Non-Major Bleeding Events [Time Frame: Up to Month 12]

Number of Participants With Trivial (Minimal) Bleeding [Time Frame: Up to Month 12]

Secondary ID(s)

39039039CHD3001

2015-002610-76

CR108075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer