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NCT02234843: EINSTEIN Jr
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
Phase 3 trial testing Rivaroxaban (Xarelto, BAY59-7939) in Venous Thromboembolism in 500 participants. Completed in 30 January 2019.
30 January 2019
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 13 November 2014 |
| Primary completion | 30 January 2019 |
| Estimated completion | 30 January 2019 |
| Sites | 109 locations across Belgium, Russia, Finland, Ireland, United States, Hungary, Mexico, Germany |
Drugs / interventions tested
- Rivaroxaban (Xarelto, BAY59-7939) — full drug profile →
- Rivaroxaban (Xarelto, BAY59-7939) — full drug profile →
- Standard of Care
Conditions studied
- Venous Thromboembolism — all drugs for Venous Thromboembolism →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02234843
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rivaroxaban (Xarelto, BAY59-7939)
Trials testing the same drug.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT06193863 — An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Hea · active not recruiting
- NCT05461807 — An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to · completed
- NCT05150938 — A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE) · completed
- NCT04923139 — A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Datab · completed
Other recruiting trials for Venous Thromboembolism
Currently open trials in the same condition.
- NCT07399977 — Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism · NA · recruiting
- NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
- NCT07140523 — A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA · Phase 2 · recruiting
- NCT04211181 — CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism · NA · recruiting
- NCT06440694 — Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial) · Phase 3 · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02234843 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 1 April 2020
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