Last updated on May 2019

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


Brief description of study

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.

Detailed Study Description

Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.

Clinical Study Identifier: NCT02846532

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Phoenix Children's Hospital

Phoenix, AZ United States
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Mattel Children's Hospital

Los Angeles, CA United States
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UCSF Benioff Children's Hospital

San Francisco, CA United States
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University of Colorado

Aurora, CO United States
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University of Iowa Hospital

Iowa City, IA United States
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The Children's Mercy Hospital

Kansas City, MO United States
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Childrens Hospital Of Philadelphia

Philadelphia, PA United States
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Texas Children's Hospital

Houston, TX United States
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Hospital de Ninos Ricardo Gutierrez

City of Buenos Aires, Argentina
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Huderf

Brussel, Belgium
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UCL St Luc

Brussel, Belgium
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UZ Leuven

Leuven, Belgium
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CHU Arnaud de Villeneuve

Montpellier Cedex 5, France
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Shizuoka Children's Hospital

Shizuoka-shi, Shizuoka, Japan
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Erasmus MC

Rotterdam, Netherlands
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UMC Utrecht

Utrecht, Netherlands
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Ramathibodi Hospital

Ratchathewi, Thailand
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Hospital de Ninos Ricardo Gutierrez

City Of Buenos Aires, Argentina
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Shizuoka Children's Hospital

Shizuoka-Shi, Shizuoka, Japan
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Recruitment Status: Open


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