A Phase 2 interventional study of Rivaroxaban (Xarelto, BAY59-7939) in Venous Thromboembolism, sponsored by Bayer. Completed at 29 sites in 15 countries. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 46 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
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Exclusion Criteria:
Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant
Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (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, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. 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 * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Time frame: During or within 2 days after stop of study treatment (up to 32 days)
Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.
Time frame: From start of the study treatment up to 30-days post study treatment period (approximately 60 days)
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.
Time frame: At the end of the 30-day treatment period
Change From Baseline in Prothrombin Time at Specified Time Points
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.
Time frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.
Time frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
Time frame: Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)
Anti-factor Xa Values at Specified Time Points
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
Time frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)
Study was conducted at 27 study centers in 14 countries: Australia, Austria, Brazil, Canada, Hungary, Israel, Italy, Japan, Netherlands, Russia, Spain, Switzerland, United Kingdom, and United States between 15 January 2015 (first subject first visit) and 05 April 2017 (last subject last visit).
| Milestone | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Anticoagulants, Comparator, Age: 2-6 Years |
|---|---|---|---|
| Started | 25 | 15 | 6 |
| Completed | 23 | 14 | 6 |
| Not completed | 2 | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 |
Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (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, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. 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 * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
| Participants | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Major bleeding events | 0 | 0 |
| Clinically relevant non-major bleeding events | 0 | 0 |
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.
| Participants | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | 0 | 0 |
The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.
| Participants | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Normalized | 6 | 4 |
| Improved | 15 | 4 |
| No relevant change | 1 | 3 |
| Deteriorated | 0 | 0 |
| Not evaluable | 0 | 0 |
| Not available | 0 | 0 |
| Missing | 3 | 4 |
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.
| Seconds | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Day 1: 2.5-4 hours post-dose | 2.777 ± 4.845 | 2.514 ± 3.53 |
| Day 15: 2-8 hours post-dose | 2.586 ± 2.387 | 4.764 ± 4.738 |
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.
| Seconds | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Day 1: 2.5-4 hours post-dose | 6.455 ± 17.036 | -3.479 ± 40.443 |
| Day 15: 2-8 hours post-dose | 2.814 ± 6.375 | 21 ± 66.761 |
Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
| microgram per liter (mcg/L) | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Day 1: 30-90 minutes post-dose | 72.8494 ± 153.76 | 68.0072 ± 160.77 |
| Day 1: 2.5-4 hours post-dose | 108.6053 ± 58.18 | 76.5371 ± 112.91 |
| Day 15: 2-8 hours post-dose | 112.3578 ± 46.37 | 61.3817 ± 451.46 |
| Day 30: 10-16 hours post-dose | 19.8714 ± 189.49 | 5.9545 ± 354.51 |
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
| microgram per liter (mcg/L) | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years |
|---|---|---|
| Day 1: 2.5-4 hours post-dose | 128.457 ± 69.615 | 87.831 ± 84.178 |
| Day 15: 2-8 hours post-dose | 103.105 ± 58.343 | 131.369 ± 96.489 |
| Day 30: 10-16 hours post-dose | 19.069 ± 17.463 | 16.952 ± 19.725 |
Collected over From start of study drug administration until 30 day post study treatment (approximately 60 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 0/25 (0%) | 0/25 (0%) | 14/25 (56%) |
| Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 0/15 (0%) | 2/15 (13.3%) | 11/15 (73.3%) |
| Anticoagulants, Comparator (2 - 6 Years Group) | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) |
| Event | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | Anticoagulants, Comparator (2 - 6 Years Group) |
|---|---|---|---|
| Optic atrophyEye disorders | 0/25 | 0/15 | 1/6 |
| HeadacheNervous system disorders | 0/25 | 0/15 | 1/6 |
| PyrexiaGeneral disorders | 0/25 | 1/15 | 0/6 |
| Respiratory disorderRespiratory, thoracic and mediastinal disorders | 0/25 | 1/15 | 0/6 |
| Event | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | Anticoagulants, Comparator (2 - 6 Years Group) |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/25 | 1/15 | 1/6 |
| NeutropeniaBlood and lymphatic system disorders | 0/25 | 1/15 | 1/6 |
| HaematocheziaGastrointestinal disorders | 0/25 | 0/15 | 1/6 |
| Rectal haemorrhageGastrointestinal disorders | 0/25 | 0/15 | 1/6 |
| GastroenteritisInfections and infestations | 0/25 | 0/15 | 1/6 |
| Viral upper respiratory tract infectionInfections and infestations | 3/25 | 0/15 | 1/6 |
| Blood fibrinogen decreasedInvestigations | 0/25 | 0/15 | 1/6 |
| Platelet count decreasedInvestigations | 0/25 | 0/15 | 1/6 |
| HypertriglyceridaemiaMetabolism and nutrition disorders | 0/25 | 0/15 | 1/6 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 0/25 | 0/15 | 1/6 |
| Age, Continuous(years) | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Anticoagulants, Comparator, Age: 2-6 Years | Total |
|---|---|---|---|---|
| Mean | 3.77 ± 1.03 | 1.26 ± 0.45 | 3.67 ± 0.82 | 2.94 ± 1.45 |
| Sex: Female, Male(Participants) | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Anticoagulants, Comparator, Age: 2-6 Years | Total |
|---|---|---|---|---|
| Female | 12 | 9 | 3 | 24 |
| Male | 13 | 6 | 3 | 22 |
| Race (NIH/OMB)(Participants) | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Anticoagulants, Comparator, Age: 2-6 Years | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 0 | 3 |
| White | 23 | 10 | 6 | 39 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
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