EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
NCT ID: NCT02234843
Last Updated: 2020-04-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2014-11-13
2019-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAY59-7939
Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.
Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets
Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension
Standard of Care
Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care
Standard of Care
LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.
dose : as per standard of care
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets
Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension
Standard of Care
LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.
dose : as per standard of care
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lansing, Michigan, United States
Kansas City, Missouri, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Miguel de Tucumán, Tucumán Province, Argentina
Parkville, Victoria, Australia
South Brisbane, , Australia
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Linz, Upper Austria, Austria
Vienna, , Austria
Bruxelles - Brussel, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Campinas, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Hangzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Shanghai, , China
Turku, , Finland
Montpellier, , France
Paris, , France
Toulouse, , France
Erlangen, Bavaria, Germany
Dresden, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Berlin, , Germany
Hong Kong, , Hong Kong
Budapest, , Hungary
Crumlin, Dublin, Ireland
Afula, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Padua, Veneto, Italy
Ōbu, Aichi-ken, Japan
Azumino, Nagano, Japan
Bunkyo-ku, Tokyo, Japan
Guadalajara, Jalisco, Mexico
Mexico City, Mexico City, Mexico
Amsterdam, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Carnaxide, Lisbon District, Portugal
Kazan', , Russia
Kemerovo, , Russia
Krasnodar, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Volgograd, , Russia
Yekaterinburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Bratislava, , Slovakia
Esplugues de Llobregat, Barcelona, Spain
A Coruña, , Spain
Barcelona, , Spain
Solna, , Sweden
Bern, , Switzerland
Lucerne, , Switzerland
Zurich, , Switzerland
Adana, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Birmingham, West Midlands, United Kingdom
Leeds, West Yorkshire, United Kingdom
Cardiff, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Oxford, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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Palumbo JS, Lensing AWA, Brandao LR, Hooimeijer HL, Kenet G, van Ommen H, Pap AF, Majumder M, Kubitza D, Thelen K, Willmann S, Prins MH, Monagle P, Male C. Anticoagulation in pediatric cancer-associated venous thromboembolism: a subgroup analysis of EINSTEIN-Jr. Blood Adv. 2022 Nov 22;6(22):5821-5828. doi: 10.1182/bloodadvances.2022008160.
Connor P, Sanchez van Kammen M, Lensing AWA, Chalmers E, Kallay K, Hege K, Simioni P, Biss T, Bajolle F, Bonnet D, Grunt S, Kumar R, Lvova O, Bhat R, Van Damme A, Palumbo J, Santamaria A, Saracco P, Payne J, Baird S, Godder K, Labarque V, Male C, Martinelli I, Morales Soto M, Motwani J, Shah S, Hooimeijer HL, Prins MH, Kubitza D, Smith WT, Berkowitz SD, Pap AF, Majumder M, Monagle P, Coutinho JM. Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT). Blood Adv. 2020 Dec 22;4(24):6250-6258. doi: 10.1182/bloodadvances.2020003244.
Thom K, Lensing AWA, Nurmeev I, Bajolle F, Bonnet D, Kenet G, Massicotte MP, Karakas Z, Palumbo JS, Saracco P, Amedro P, Chain J, Chan AK, Ikeyama T, Lam JCM, Gauger C, Pap AF, Majumder M, Kubitza D, Smith WT, Berkowitz SD, Prins MH, Monagle P, Young G, Male C. Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE). Blood Adv. 2020 Oct 13;4(19):4632-4639. doi: 10.1182/bloodadvances.2020002637.
Male C, Lensing AWA, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bonnet D, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Chalmers E, Simioni P, Bhat RV, Yee DL, Lvova O, Beyer-Westendorf J, Biss TT, Martinelli I, Saracco P, Peters M, Kallay K, Gauger CA, Massicotte MP, Young G, Pap AF, Majumder M, Smith WT, Heubach JF, Berkowitz SD, Thelen K, Kubitza D, Crowther M, Prins MH, Monagle P; EINSTEIN-Jr Phase 3 Investigators. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e18-e27. doi: 10.1016/S2352-3026(19)30219-4. Epub 2019 Nov 5.
Monagle P, Lensing AWA, Thelen K, Martinelli I, Male C, Santamaria A, Samochatova E, Kumar R, Holzhauer S, Saracco P, Simioni P, Robertson J, Grangl G, Halton J, Connor P, Young G, Molinari AC, Nowak-Gottl U, Kenet G, Kapsa S, Willmann S, Pap AF, Becka M, Twomey T, Beyer-Westendorf J, Prins MH, Kubitza D; EINSTEIN-Jr Phase 2 Investigators. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. Lancet Haematol. 2019 Oct;6(10):e500-e509. doi: 10.1016/S2352-3026(19)30161-9. Epub 2019 Aug 13.
Lensing AWA, Male C, Young G, Kubitza D, Kenet G, Patricia Massicotte M, Chan A, Molinari AC, Nowak-Goettl U, Pap AF, Adalbo I, Smith WT, Mason A, Thelen K, Berkowitz SD, Crowther M, Schmidt S, Price V, Prins MH, Monagle P. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study. Thromb J. 2018 Dec 21;16:34. doi: 10.1186/s12959-018-0188-y. eCollection 2018.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-000565-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14372
Identifier Type: -
Identifier Source: org_study_id
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