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 |
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.
(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.
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
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