EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

Last updated: March 13, 2020
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Venous Thromboembolism

Blood Clots

Thromboembolism

Treatment

N/A

Clinical Study ID

NCT02234843
14372
2014-000565-47
  • Ages < 17
  • All Genders

Study 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

Inclusion Criteria:

  • Children aged birth to < 18 years with confirmed venous thromboembolism who receiveinitial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (lowmolecular weight heparin) or fondaparinux and require anticoagulant therapy for atleast 90 days. However, children aged birth to < 2 years with catheter-relatedthrombosis 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

Exclusion Criteria:

  • Active bleeding or bleeding risk contraindicating anticoagulant therapy

  • An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in childrenyounger than 1 year, serum creatinine results above 97.5th percentile excludesparticipation)

  • Hepatic disease which is associated with either: coagulopathy leading to a clinicallyrelevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2xULN 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 immunodeficiencyvirus 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 breastfeeding

Study Design

Total Participants: 500
Study Start date:
November 13, 2014
Estimated Completion Date:
January 30, 2019

Connect with a study center

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    Bahia Blanca, Buenos Aires B8001HXM
    Argentina

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    Buenos Aires, Ciudad Auton. de Buenos Aires C1425EFD
    Argentina

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  • San Miguel de Tucumán, Tucuman 4000
    Argentina

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    Salta, A4400ESE
    Argentina

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  • Parkville, Victoria 3052
    Australia

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  • South Brisbane, 4101
    Australia

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  • Linz, Oberösterreich 4020
    Austria

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  • Graz, Steiermark 8036
    Austria

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  • Innsbruck, Tirol 6020
    Austria

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  • Wien, 1090
    Austria

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  • Bruxelles - Brussel, 1200
    Belgium

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  • Edegem, 2650
    Belgium

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  • Leuven, 3000
    Belgium

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    Belo Horizonte, Minas Gerais 30130-100
    Brazil

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  • Campinas, Sao Paulo 13083-970
    Brazil

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  • São Paulo, Sao Paulo 01227-200
    Brazil

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  • Sao Paulo, 04023-061
    Brazil

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    Sofia, 1309
    Bulgaria

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  • Calgary, Alberta T3B 6A8
    Canada

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  • Edmonton, Alberta T6G 2B7
    Canada

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  • Hamilton, Ontario L8N 3Z5
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  • Ottawa, Ontario K1H 8L1
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  • Montreal, Quebec H4A 3J1
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    Chongqing,
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    HUS, 00029
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    Finland

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    Bordeaux, 33000
    France

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    Lille, 59037
    France

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    France

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    PESSAC cedex, 33604
    France

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  • Paris, 75015
    France

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    Rennes Cedex, 35056
    France

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  • TOULOUSE Cedex 9, 31059
    France

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    Freiburg, Baden-Württemberg 79106
    Germany

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    Stuttgart, Baden-Württemberg 70176
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    Germany

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    Frankfurt, Hessen 60590
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    Lübeck, Schleswig-Holstein 23538
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    Tel Hashomer, 5262000
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    Genova, 16147
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    Pavia, 27100
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    Sagamihara, Kanagawa 252-0375
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    Fuchu, Tokyo 183-8561
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    Setagaya, Tokyo 157-8535
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    Shinjuku-ku, Tokyo 162-8666
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    Akita, 010-8543
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    Fukuoka, 813-0017
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    Pachuca, Hidalgo 42070
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    Queretaro, Querétaro 78000
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    Olsztyn, 10-561
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    Porto, 4200-319
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    Cluj-Napoca, 400370
    Romania

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    Targu Mures, 540136
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    Ekaterinburg, 62219
    Russian Federation

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    Russian Federation

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    Russian Federation

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    Kirov, 610027
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    Russian Federation

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    Ufa, 450106
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    Alicante, 03010
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    Sevilla, 41013
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    Valencia, 46026
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    Malmö, 205 02
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    Stockholm, 171 76
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    St. Gallen, Sankt Gallen 9006
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  • Adana, 01130
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    Ankara, 06100
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    Antalya, 07059
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    Bursa, 16059
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    Kocaeli, 41380
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  • London, SW3 6NP
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  • Manchester, M13 9WL
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    Oakland, California 94609
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    New Hyde Park, New York 11040
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