Rivaroxaban in Pediatric Patients With DVT

NCT07618988 | Completed Phase 4 DMC

• 1 other identifier: FMASU MD 156/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric Venous Thromboembolism

Keywords

Children; Deep venous thrombosis; Direct oral anticoagulant; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Degree of vein recanalization

  A Repeat site-appropriate imaging at 3 months will be done to assess the degree of vein recanalization and response will be classified as * Normalized: if no residual thrombus is observed, * Improved: if thrombus is still present but partly recanalized or involving less venous segments, * Unchanged: if not recanalized and similar in extent * Deteriorated: if new venous segment involved

  3 months

Study Arms (2)

LMWH arm

ACTIVE COMPARATOR

Patients assigned to LMWH will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration.

Drug: Enoxaparin, Heparin

Rivaroxaban

EXPERIMENTAL

Patients allocated to Rivaroxaban: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally.

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Patients allocated to Rivaroxaban arm: after 5 to 9 days of therapy with low molecular weight heparin (LMWH), patients will receive body weight-adjusted 20-mg equivalent doses with an age-appropriate serving of fluid given with or shortly after a meal. Crushed Rivaroxaban tablet is stable for up to 4 hours and displays similar relative bioavailability compared to a whole tablet administered orally.

Rivaroxaban

Enoxaparin, Heparin DRUG

Patients in arm 1 will receive standard anticoagulation with enoxaparin sodium at a dose 1mg/kg twice daily for 3 months duration

LMWH arm

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients from 6 months to less than 18 years of age.
• Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT.
• Patients with cancer associated thrombosis are eligible.
• Patients with provoked or unprovoked acute VT are eligible.
• Patients with first thrombotic event or recurrent VT are eligible.

You may not qualify if:

• Patients with active bleeding
• High-risk of bleeding including:
• Platelet count of less than 50 x 109/L,
• Liver disease associated either a coagulopathy leading to a clinically relevant bleeding risk, or ALT \> 5× ULN.
• Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \> 95th age percentile.
• Severe renal impairment (Estimated glomerular filtration rate \< 30 mL/min/1.73m2).
• Gastrointestinal disease associated with impaired absorption.
• Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment.
• Patients with rheumatic heart disease or prosthetic heart valves.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Children's Hospital

Cairo, 11566, Egypt

Location

Related Publications (4)

• 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.

  PMID: 27128839 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.

  PMID: 30598642 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.

  PMID: 32246743 BACKGROUND

• 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.

  PMID: 31699660 RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Rivaroxaban; Enoxaparin; Heparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fatma SE Ebeid, MD

  Faculty of Medicine Ain Shams University

  STUDY DIRECTOR

• Amira Adly

  Faculty of Medicine Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 1, 2026
• Study Start: August 3, 2024
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)