Oral Rivaroxaban in Children With Venous Thrombosis

Completed · Phase 2

Conditions studied: Venous Thrombosis

In brief

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

Key facts

Study ID

NCT01684423

Run by

Bayer

People needed

64

Starts

2013-02-19

Expected to finish

2016-09-01

Last updated by the study team

2017-09-21

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 6 to < 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux and/or VKA (vitamin K antagonist).
• Informed consent provided and, if applicable, child assent provided

You may not qualify if…

• Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
• Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
• Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
• An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
• Hepatic disease which is associated with 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 10\^9/L
• 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), i.e. 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, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — New Hyde Park, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Westmead, New South Wales, Australia
• Study site — Parkville, Victoria, Australia
• Study site — South Brisbane, Australia
• Study site — Graz, Styria, Austria
• Study site — Innsbruck, Tyrol, Austria
• Study site — Linz, Upper Austria, Austria
• Study site — Vienna, Austria
• Study site — Edmonton, Alberta, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Québec, Canada
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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