Rivaroxaban for treatment in venous thrombosis in young children

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in young children with various manifestations of venous thrombosis - EINSTEIN Junior Phase II-part B: oral rivaroxaban in young children with venous

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000566-22-IE

Enrollment

Registered

2014-05-15

Start date

2014-07-11

Completion date

Unknown

Last updated

2017-12-11

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

Conditions

Venous Thrombosis MedDRA version: 18.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Interventions

Product Name: Xarelto Product Code: BAY59-7939 Pharmaceutical Form: Oral suspension INN or Proposed INN: RIVAROXABAN CAS Number: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg/ml

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. Symptomatic progression of venous thrombosis during preceding anticoagulant treatment 3. Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment 4. An estimated glomerular filtration rate (eGFR) 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total 6. Platelet count 95th age percentile a 8. Life expectancy < 3 months 9. 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 (fluconazole is allowed) 10. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine 11. Hypersensitivity or any other contraindication listed in the local labeling for the experimental treatment 12. Inability to cooperate with the study procedures 13. Previous enrollment to this study 14. Participation in a study with an investigational drug or medical device within 30 days prior to Visit 2.

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the incidence of major bleeding and clinically relevant non-major bleeding;Secondary Objective: 1) to assess the incidence of recurrent venous thromboembolism 2) to assess asymptomatic deterioration in the thrombotic burden on repeat imaging 3) to characterize the pharmacokinetic/pharmacodynamic profile of a 30-day treatment with oral rivaroxaban.;Primary end point(s): Composite of major and clinically relevant non-major bleeding;Timepoint(s) of evaluation of this end point: During or within 2 days after stop of study treatment	—

Measure

Time frame

Main Objective: to assess the incidence of major bleeding and clinically relevant non-major bleeding;Secondary Objective: 1) to assess the incidence of recurrent venous thromboembolism 2) to assess asymptomatic deterioration in the thrombotic burden on repeat imaging 3) to characterize the pharmacokinetic/pharmacodynamic profile of a 30-day treatment with oral rivaroxaban.;Primary end point(s): Composite of major and clinically relevant non-major bleeding;Timepoint(s) of evaluation of this end point: During or within 2 days after stop of study treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1. Composite of all recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging; results of pharmacokinetics (PK) / pharmacodynamics (PD). 2. Prothrombin time 3. Activated partial thromboplastin time;Timepoint(s) of evaluation of this end point: 1. At 31 Days 2. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16) 3. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)	—

Measure

Time frame

Secondary end point(s): 1. Composite of all recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging; results of pharmacokinetics (PK) / pharmacodynamics (PD). 2. Prothrombin time 3. Activated partial thromboplastin time;Timepoint(s) of evaluation of this end point: 1. At 31 Days 2. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16) 3. Day1 (post dose at.5-1.5h, 2.5-4h),day 15 (post dose at 2-8h) and day 30 (post dose at 10-16)

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

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