Trial · NCT02309411
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
NCT02309411, Phase 2, Completed, Bayer; results first posted 2018-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis. Trials, record NCT02309411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02309411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
- NCT number
- NCT02309411
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Venous Thromboembolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939)
- First posted
- 2014-12-05
- Last updated
- 2018-08-21
- Other registries' IDs
- eudract:2014-000566-22
- Results first posted
- 2018-06-13
- Limitations and caveats
Study started as randomized but the Comparator arm sample size was too small for meaningful comparison; it was removed in Protocol amendment and approved by review board. Results only reported for rivaroxaban arm as single arm study.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | During or within 2 days after stop of study treatment (up to 32 days) | 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). |
| Secondary | Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | From start of the study treatment up to 30-days post study treatment period (approximately 60 days) | 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. |
| Secondary | Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | At the end of the 30-day treatment period | 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. |
| Secondary | Change From Baseline in Prothrombin Time at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) | 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. |
| Secondary | Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) | 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. |
| Secondary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points | 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) | 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. |
| Other | Anti-factor Xa Values at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | During or within 2 days after stop of study treatment (up to 32 days) | SAF included all subjects who received at least one dose of the study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | From start of the study treatment up to 30-days post study treatment period (approximately 60 days) | FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system \[IxRS\], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | At the end of the 30-day treatment period | FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system \[IxRS\], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Prothrombin Time at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) | PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication. | Seconds | MEAN |
| SECONDARY | Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) | PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication. | Seconds | MEAN |
| SECONDARY | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points | 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) | PKS included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy. | microgram per liter (mcg/L) | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Anti-factor Xa Values at Specified Time Points | Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose) | PDS included all subjects with at least one blood sample for clotting tests in accordance with the pharmacodynamic sampling strategy was included. | microgram per liter (mcg/L) | MEAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Major bleeding events | 0 | Participants | |
| Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Major bleeding events | 0 | Participants | |
| Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Clinically relevant non-major bleeding events | 0 | Participants | |
| Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Clinically relevant non-major bleeding events | 0 | Participants | |
| Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | Rivaroxaban, Suspension, BID, Age: 2-6 Years | 0 | Participants | ||
| Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | 0 | Participants | ||
| Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Normalized | 6 | Participants | |
| Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Normalized | 4 | Participants | |
| Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban, Suspension, BID, Age: 2-6 Years | Improved | 15 | Participants | |
| Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | Improved | 4 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban, Suspension, BID, Age: 2-6 Years | 25 | |
| Overall Study | STARTED | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | 15 | |
| Overall Study | STARTED | Anticoagulants, Comparator, Age: 2-6 Years | 6 | |
| Overall Study | COMPLETED | Rivaroxaban, Suspension, BID, Age: 2-6 Years | 23 | |
| Overall Study | COMPLETED | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | 14 | |
| Overall Study | COMPLETED | Anticoagulants, Comparator, Age: 2-6 Years | 6 | |
| Overall Study | NOT COMPLETED | Rivaroxaban, Suspension, BID, Age: 2-6 Years | 2 | |
| Overall Study | NOT COMPLETED | Rivaroxaban Suspension, BID, Age: 6 Months-2 Years | 1 | |
| Overall Study | NOT COMPLETED | Anticoagulants, Comparator, Age: 2-6 Years | 0 |
Source ClinicalTrials.gov
Adverse events219
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 2 | 25 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Anticoagulants, Comparator (2 - 6 Years Group) | 0 | 6 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 1 | 25 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 1 | 15 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Anticoagulants, Comparator (2 - 6 Years Group) | 1 | 6 | 1 |
| other | Monocytosis | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 0 | 25 | 0 |
| other | Monocytosis | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 1 | 15 | 1 |
| other | Monocytosis | Blood and lymphatic system disorders | Anticoagulants, Comparator (2 - 6 Years Group) | 0 | 6 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 0 | 25 | 0 |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 0 | 25 |
| Total, all-cause mortality | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 0 | 15 |
| Total, all-cause mortality | Anticoagulants, Comparator (2 - 6 Years Group) | 0 | 6 |
| Total, other adverse events | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 14 | 25 |
| Total, other adverse events | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 11 | 15 |
| Total, other adverse events | Anticoagulants, Comparator (2 - 6 Years Group) | 3 | 6 |
| Total, serious adverse events | Rivaroxaban BID (Suspension) (2 - 6 Years Group) | 0 | 25 |
| Total, serious adverse events | Rivaroxaban BID (Suspension) (6 Months - 2 Years Group) | 2 | 15 |
| Total, serious adverse events | Anticoagulants, Comparator (2 - 6 Years Group) | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31420317 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rivaroxaban, Suspension, BID, Age: 2-6 Years vs Rivaroxaban Suspension, BID, Age: 6 Months-2 Years: Number of Subjects With Symptomatic Recurrent Venous Thromboembolism |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02309411
GET https://conductscience.org/api/trials/v1/NCT02309411/results?page=2