Rivaroxaban for treatment in venous thrombosis in children

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004539-30-AT

Enrollment

Registered

2012-08-20

Start date

2012-10-23

Completion date

Unknown

Last updated

2016-11-14

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

Conditions

venous thrombosis MedDRA version: 19.0 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: 366789-02-8 Current Sponsor code: BAY 59-7939 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 6 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 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 8. Life expectancy < 3 months 9. Concomitant use of strong inhibitors of both CYP3A4 and 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. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding 12. Any other contraindication listed in the local labeling for the experimental treatment 13. Inability to cooperate with the study procedures 14. Previous enrollment to this study 15. 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: The primary objective is: • to assess the incidence of major bleeding and clinically relevant non-major bleeding ;Secondary Objective: The secondary objectives are: • to assess the incidence of recurrent venous thromboembolism • to assess asymptomatic deterioration in the thrombotic burden on repeat imaging • to characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban ;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Measure

Time frame

Main Objective: The primary objective is: • to assess the incidence of major bleeding and clinically relevant non-major bleeding ;Secondary Objective: The secondary objectives are: • to assess the incidence of recurrent venous thromboembolism • to assess asymptomatic deterioration in the thrombotic burden on repeat imaging • to characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban ;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Australia, Austria, Canada, France, Germany, Israel, Italy, Netherlands, Switzerland, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

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