Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure (UNIVERSE)
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|ClinicalTrials.gov Identifier: NCT02846532|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis||Drug: Rivaroxaban Drug: Acetylsalicylic Acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||November 16, 2016|
|Actual Primary Completion Date :||July 16, 2020|
|Actual Study Completion Date :||July 16, 2020|
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.
|Experimental: Acetylsalicylic Acid||
Drug: Acetylsalicylic Acid
Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Month 12 ]The Cmax is the maximum observed Plasma concentration.
- Area Under the Analyte ConcentrationTime Curve From Time 0 to 24 Hours (AUC24) [ Time Frame: Up to Month 12 ]The AUC24 is the area under the plasma concentration-time curve from time 0 to 24 hours.
- Maximum Plasma Concentration (Cmax,ss) at Steady State [ Time Frame: Up to Month 12 ]The Cmax,ss is the maximum observed plasma concentration at steady state.
- Minimum Plasma Concentration (Cmin,ss) at Steady State [ Time Frame: Up to Month 12 ]The Cmin,ss is the minimum observed plasma concentration at steady state.
- Absolute Prothrombin Time (PT) [ Time Frame: Up to Month 12 ]Absolute prothrombin time (PT) will be assessed as pharmacodynamic parameter.
- Activated Partial Thromboplastin Time (aPTT) [ Time Frame: Up to Month 12 ]Activated partial thromboplastin time (aPTT) will be assessed as pharmacodynamic parameter.
- Anti-Factor Xa (FXa) [ Time Frame: Up to Month 12 ]Anti-factor Xa (FXa) will be assessed as pharmacodynamic parameter.
- Number of Participants With Major Bleeding Events [ Time Frame: Up to Month 12 ]Major bleeding is defined as 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.
- Number of Participants With Incidence of Thrombotic Events [ Time Frame: Up to Month 12 ]Thrombotic event is 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).
- 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 ]Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (Temporary) cessation of study treatment, or discomfort for the subject such as pain, or impairment of activities of daily life (such as loss of school days or hospitalization).
- Number of Participants With Trivial (Minimal) Bleeding [ Time Frame: Up to Month 12 ]Trivial (minimal) bleeding is defined as any other overt bleeding event that does not meet criteria for clinically relevant non major bleeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846532
|United States, California|
|Los Angeles, California, United States|
|United States, Florida|
|Gainesville, Florida, United States|
|United States, Illinois|
|Oak Lawn, Illinois, United States|
|United States, Indiana|
|Indianapolis, Indiana, United States|
|United States, Iowa|
|Iowa City, Iowa, United States|
|United States, Maryland|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Minnesota|
|Minneapolis, Minnesota, United States|
|United States, Nebraska|
|Omaha, Nebraska, United States|
|United States, North Carolina|
|Durham, North Carolina, United States|
|United States, Ohio|
|Cincinnati, Ohio, United States|
|United States, Pennsylvania|
|Hershey, Pennsylvania, United States|
|Philadelphia, Pennsylvania, United States|
|United States, Tennessee|
|Memphis, Tennessee, United States|
|United States, Texas|
|Houston, Texas, United States|
|United States, Utah|
|Salt Lake City, Utah, United States|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States|
|Buenos Aires, Argentina|
|Porto Alegre, Brazil|
|São Paulo, Brazil|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada|
|Toronto, Ontario, Canada|
|Montreal, Quebec, Canada|
|Shizuoka-shi, Shizuoka, Japan|
|Kuala Lumpur, Malaysia|
|A Coruña, Spain|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|