Rivaroxaban for treatment in venous thrombosis in children

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism - EINSTEIN Junior Phase III: oral rivaroxaban in young children with

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000565-47-ES

Enrollment

150

Registered

2014-06-09

Start date

2014-07-25

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombosis MedDRA version: 17.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Interventions

Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIVAROXABAN CAS Number: 3667

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy 2. An estimated glomerular filtration rate (eGFR) 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total 4. Platelet count 95th age percentile a 6. Life expectancy < 3 months 7. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically 8. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine 9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 10. Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment 11. Inability to cooperate with the study procedures 12. Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. An additional objective is: To characterize the pharmacokinetic / pharmacodynamics profile of rivaroxaban. ; Main Objective: The primary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism The principal safety objective is: To assess the incidence of overt major and clinically relevant non-major bleeding. ; Primary end point(s): 1. Efficacy: The composite of all symptomatic recurrent venous thromboembolism 2. Safety: The composite of overt major and clinically relevant non-major bleeding. ; Timepoint(s) of evaluation of this end point: 1. Up to 3 months 2. Up to 3 months	—

Measure

Time frame

Secondary Objective: The secondary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging. An additional objective is: To characterize the pharmacokinetic / pharmacodynamics profile of rivaroxaban. ; Main Objective: The primary efficacy objective is: To assess the incidence of symptomatic recurrent venous thromboembolism The principal safety objective is: To assess the incidence of overt major and clinically relevant non-major bleeding. ; Primary end point(s): 1. Efficacy: The composite of all symptomatic recurrent venous thromboembolism 2. Safety: The composite of overt major and clinically relevant non-major bleeding. ; Timepoint(s) of evaluation of this end point: 1. Up to 3 months 2. Up to 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): The composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging.;Timepoint(s) of evaluation of this end point: Up to 3 months.	—

Countries

Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com0034.900102372

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026