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NCT02234843: EINSTEIN Jr

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

Completed Phase 3 Results posted Last updated 1 April 2020
What this trial tests

Phase 3 trial testing Rivaroxaban (Xarelto, BAY59-7939) in Venous Thromboembolism in 500 participants. Completed in 30 January 2019.

Timeline
13 November 2014
Primary endpoint
30 January 2019
30 January 2019

Quick facts

Lead sponsorBayer
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment500
Start date13 November 2014
Primary completion30 January 2019
Estimated completion30 January 2019
Sites109 locations across Belgium, Russia, Finland, Ireland, United States, Hungary, Mexico, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Under 17, any sex, with Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial.
    Male C, Lensing AWA, Palumbo JS, Kumar R, et al · · 2020 · cited 209× · PMID 31699660 · DOI 10.1016/s2352-3026(19)30219-4
  2. Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (EINSTEIN-Jr CVT).
    Connor P, Sánchez van Kammen M, Lensing AWA, Chalmers E, et al · · 2020 · cited 78× · PMID 33351120 · DOI 10.1182/bloodadvances.2020003244
  3. Management of thrombosis in children and neonates: practical use of anticoagulants in children.
    Monagle P, Newall F. · · 2018 · cited 63× · PMID 30504338 · DOI 10.1182/asheducation-2018.1.399
  4. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies.
    Monagle P, Lensing AWA, Thelen K, Martinelli I, et al · · 2019 · cited 52× · PMID 31420317 · DOI 10.1016/s2352-3026(19)30161-9
  5. Role of direct oral anticoagulants in patients with kidney disease.
    Derebail VK, Rheault MN, Kerlin BA. · · 2020 · cited 38× · PMID 32107019 · DOI 10.1016/j.kint.2019.11.027
  6. Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE).
    Thom K, Lensing AWA, Nurmeev I, Bajolle F, et al · · 2020 · cited 37× · PMID 33002131 · DOI 10.1182/bloodadvances.2020002637
  7. Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review.
    Bose G, Graveline J, Yogendrakumar V, Shorr R, et al · · 2021 · cited 30× · PMID 33593766 · DOI 10.1136/bmjopen-2020-040212
  8. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study.
    Lensing AWA, Male C, Young G, Kubitza D, et al · · 2018 · cited 30× · PMID 30598642 · DOI 10.1186/s12959-018-0188-y

Verify or expand the search:

Other trials of Rivaroxaban (Xarelto, BAY59-7939)

Trials testing the same drug.

Other recruiting trials for Venous Thromboembolism

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Other Bayer trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02234843.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing