Rivaroxaban in Pediatric Patients With DVT

Summary

Prospective interventional randomized controlled trial to assess safety and efficacy of rivaroxaban in pediatric patients with acute deep venous thrombosis.

Timeline

Start

2024-08-03

Primary completion

2025-12-31

Completion

2026-05-01

Publications

• Background Moore KT, Krook MA, Vaidyanathan S, Sarich TC, Damaraju CV, Fields LE. Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube. Clin Pharmacol Drug Dev. 2014 Jul;3(4):321-7. doi: 10.1002/cpdd.123. Epub 2014 May 16.
• Background 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.
• Background Young G, Lensing AWA, Monagle P, Male C, Thelen K, Willmann S, Palumbo JS, Kumar R, Nurmeev I, Hege K, Bajolle F, Connor P, Hooimeijer HL, Torres M, Chan AKC, Kenet G, Holzhauer S, Santamaria A, Amedro P, Beyer-Westendorf J, Martinelli I, Massicotte MP, Smith WT, Berkowitz SD, Schmidt S, Price V, Prins MH, Kubitza D; EINSTEIN-Jr. Phase 3 Investigators. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation. J Thromb Haemost. 2020 Jul;18(7):1672-1685. doi: 10.1111/jth.14813. Epub 2020 Jun 4.
• Results 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.

Drugs

Indications