Catheter related venous or arterial thrombosis
Conditions
Interventions
Product Name: rivaroxaban
Product Code: BAY59-7939
Pharmaceutical Form: Oral suspension
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Current Sponsor code: BAY59-7939
Concentration unit: mg
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Children from birth to less than 6 months with documented symptomatic or asymptomatic catheter-related venous or arterial thrombosis who will enter their last 7 days of intended anticoagulant treatment. 2.Gestational age at birth of at least 37 weeks. 3.Hemoglobin, platelets assessed within 10 days prior to enrollment. 4.Oral feeding/nasogastric/gastric feeding for at least 10 days. 5.Informed consent provided. Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding. 2. Symptomatic progression of thrombosis during preceding anticoagulant treatment. 3. Planned invasive procedures, including lumbar puncture and removal of nonperipherally placed central lines during study treatment. 4. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total. 5. Creatinine >1.5 times of normal. 6. Hypertension defined as >95th percentile. 7. History of gastrointestinal disease or surgery associated with impaired absorption. 8. Platelet count <100 x 109/L. 9. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp). 10. Concomitant use of strong inducers of CYP3A4. 11. Indication for anticoagulant therapy other than current thrombosis. 12. Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. 13. Hypersensitivity to rivaroxaban or its excipients. 14. Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxaban;Secondary Objective: - to assess the incidence of major bleeding and clinically relevant non-major bleeding - to assess the incidence of symptomatic recurrent thromboembolism and - to assess asymptomatic deterioration in the thrombotic burden on repeat imaging;Primary end point(s): PK/PD modeling, using population approaches will be used to describe the pharmacokinetics of rivaroxaban, and to relate anticoagulant parameters of rivaroxaban with plasma concentrations.;Timepoint(s) of evaluation of this end point: After last patient. last visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden will be summarized. 2. All safety analyses will be performed on the safety population. Bleeding events observed later will be described separately. Individual listings of major and clinically relevant non-major bleeding will be provided. 3. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden;Timepoint(s) of evaluation of this end point: 1. After last patient, last visit 2.The analysis will primarily focus on bleeding that occurred during or within 2 days after stop of rivaroxaban 3. After last patient, last visit | — |
Countries
Australia, Austria, Canada, Finland, France, Germany, Israel, Italy, Netherlands, Poland, Spain, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed