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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:2 - 8
Updated:4/6/2019
Start Date:November 16, 2016
End Date:October 29, 2020
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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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

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.

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.

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
We found this trial at
25
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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Aurora, Colorado 80045
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Baltimore, Maryland 21201
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Baltimore, MD
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Buenos Aires,
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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2000 Southwest Archer Road
Gainesville, Florida 32610
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Gainesville, FL
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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Hershey, PA
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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8433 Harcourt Road
Indianapolis, Indiana 46260
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Indianapolis, IN
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Iowa City, Iowa 52242
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Iowa City, IA
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Iowa City, IA
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Los Angeles, California 90095
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50 North Dunlap Street
Memphis, Tennessee 38103
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Memphis, TN
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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Minneapolis, Minnesota 55455
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Oak Lawn, Illinois 60453
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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Salt Lake City, UT
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San Francisco, California 94143
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San Francisco, CA
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Wilmington, Delaware 19803
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Wilmington, DE
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