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

PHASE3CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

November 16, 2016

Primary Completion Date

July 16, 2020

Study Completion Date

July 16, 2020

Conditions
Thrombosis
Interventions
DRUG

Rivaroxaban

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.

DRUG

Acetylsalicylic Acid

Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.

Trial Locations (42)

Unknown

Los Angeles

Gainesville

Oak Lawn

Indianapolis

Iowa City

Baltimore

Boston

Minneapolis

Omaha

Durham

Cincinnati

Hershey

Philadelphia

Memphis

Houston

Salt Lake City

Milwaukee

Buenos Aires

Córdoba

Brussels

Ghent

Leuven

Curitiba

Porto Alegre

São Paulo

Vancouver

Toronto

Montreal

Fukuoka

Kitakyushu-shi

Setagaya Ku

Shizuoka

Kuala Lumpur

México

Leiden

Rotterdam

Utrecht

A Coruña

Barcelona

Bilbao

Madrid

Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT02846532 - Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure | Biotech Hunter | Biotech Hunter