EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

Completed · Phase 2

Conditions studied: Venous Thromboembolism

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. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Key facts

Study ID

NCT02309411

Run by

Bayer

People needed

46

Starts

2015-01-15

Expected to finish

2017-04-05

Last updated by the study team

2018-08-21

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 6 months to < 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
• Informed consent 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 m\^2
• 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 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
• Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
• Inability to cooperate with the study procedures
• Previous randomization to this study
• Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Where it is running

• Study site — Gainesville, Florida, United States
• Study site — Pensacola, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Parkville, Victoria, Australia
• Study site — Vienna, Austria
• Study site — São Paulo, São Paulo, Brazil
• Study site — São Paulo, Brazil
• Study site — Toronto, Ontario, Canada
• Study site — Budapest, Hungary
• Study site — Jerusalem, Israel
• Study site — Ramat Gan, Israel
• Study site — Milan, Lombardy, Italy
• Study site — Turin, Piedmont, Italy
• Study site — Padova, Veneto, Italy
• Study site — Setagaya City, Tokyo, Japan
• Study site — Nijmegen, Netherlands
• Study site — Gdansk, Poland
• Study site — Olsztyn, Poland
• Study site — Moscow, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Saint Petersburg, Russia
• Study site — Barcelona, Spain
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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