Status:
COMPLETED
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
Eligibility Criteria
Inclusion
- Children aged birth to \< 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to \< 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
- For children younger than 6 months:
- Gestational age at birth of at least 37 weeks.
- Oral feeding/nasogastric/gastric feeding for at least 10 days.
- Body weight ≥2600 g
Exclusion
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
- Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT\> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
- Platelet count \< 50 x 109/L
- Sustained uncontrolled hypertension defined as \> 95th age percentile
- Life expectancy \< 3 months
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
- Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
Key Trial Info
Start Date :
November 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02234843
Start Date
November 13 2014
End Date
January 30 2019
Last Update
April 1 2020
Active Locations (109)
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1
Phoenix, Arizona, United States, 85016
2
Little Rock, Arkansas, United States, 72202-3500
3
Los Angeles, California, United States, 90027-6089
4
Los Angeles, California, United States, 90095