EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

Completed · Phase 3

Conditions studied: Venous Thromboembolism

In brief

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

Key facts

Study ID

NCT02234843

Run by

Bayer

People needed

500

Starts

2014-11-13

Expected to finish

2019-01-30

Last updated by the study team

2020-04-01

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lansing, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Miguel de Tucumán, Tucumán Province, Argentina
• Study site — Parkville, Victoria, Australia
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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