- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846532
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure (UNIVERSE)
March 2, 2022 updated by: Janssen Research & Development, LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
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Cordoba, Argentina
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Brussel, Belgium
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Gent, Belgium
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Leuven, Belgium
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Curitiba, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Fukuoka, Japan
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Kitakyushu-shi,, Japan
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Setagaya-ku, Japan
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Shizuoka-shi, Shizuoka, Japan
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Kuala Lumpur, Malaysia
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Mexico, Mexico
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Leiden, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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A Coruña, Spain
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Barcelona, Spain
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Bilbao, Spain
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Madrid, Spain
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Valencia, Spain
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California
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Los Angeles, California, United States
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Florida
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Gainesville, Florida, United States
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Illinois
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Oak Lawn, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Iowa
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Iowa City, Iowa, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Nebraska
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Omaha, Nebraska, United States
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North Carolina
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Durham, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Tennessee
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Memphis, Tennessee, United States
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Texas
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Houston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Wisconsin
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rivaroxaban
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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.
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Experimental: Acetylsalicylic Acid
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Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
Time Frame: Up to 12 months
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Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism).
The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.
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Up to 12 months
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Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 0.5-1.5 hours postdose
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Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 1.5-4 hours postdose
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Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: Up to 3 hours predose
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Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 0.5-1.5 hours postdose
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Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 1.5-4 hours postdose
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Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 6-8 hours postdose
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Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: Up to 3 hours predose
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Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 0.5-1.5 hours postdose
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Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
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Plasma rivaroxaban concentrations for Parts A and B were assessed.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 2.5-4 hours postdose
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Percentage of Participants With Bleeding Events
Time Frame: Up to 12 months
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Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events.
Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death.
CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life.
Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.
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Up to 12 months
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Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
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Absolute prothrombin time was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 0.5-1.5 hours postdose
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Absolute PT at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 1.5-4 hours postdose
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Absolute PT at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
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Day 4: Up to 3 hours predose
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Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 0.5-1.5 hours postdose
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Absolute PT at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 1.5-4 hours postdose
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Absolute PT at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 6-8 hours postdose
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Absolute PT at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: Up to 3 hours predose
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Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 0.5-1.5 hours postdose
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Absolute PT at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
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Absolute PT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 2.5-4 hours postdose
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Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 0.5-1.5 hours postdose
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aPTT at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.
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Day 1: 1.5-4 hours postdose
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aPTT at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: Up to 3 hours predose
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aPTT at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
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Day 4: 0.5-1.5 hours postdose
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aPTT at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.
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Day 4: 1.5-4 hours postdose
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aPTT at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 6-8 hours postdose
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aPTT at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: Up to 3 hours predose
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aPTT at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 0.5-1.5 hours postdose
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aPTT at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
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aPTT was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 2.5-4 hours postdose
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Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 0.5-1.5 hours postdose
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Anti-FXa at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 1: 1.5-4 hours postdose
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Anti-FXa at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Day 4: 6-8 hours postdose
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Anti-FXa at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: Up to 3 hours predose
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Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 0.5-1.5 hours postdose
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Anti-FXa at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
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Anti-FXa was assessed as pharmacodynamic parameter.
Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
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Month 3: 2.5-4 hours postdose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
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TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive.
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Up to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2016
Primary Completion (Actual)
July 16, 2020
Study Completion (Actual)
July 16, 2020
Study Registration Dates
First Submitted
July 25, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
March 28, 2022
Last Update Submitted That Met QC Criteria
March 2, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thrombosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Aspirin
- Rivaroxaban
Other Study ID Numbers
- CR108075
- 39039039CHD3001 (Other Identifier: Janssen Research & Development, LLC)
- 2015-002610-76 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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