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Rivaroxaban in Pediatric Patients With DVT

NCT07618988 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-01

No results posted yet for this study

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

Interventions

DRUG

Rivaroxaban

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.

DRUG

Enoxaparin, Heparin

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Fatma SE Ebeid, MD · Faculty of Medicine Ain Shams University

  • Amira Adly · Faculty of Medicine Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2025-12-31
Completion
2026-05-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618988 on ClinicalTrials.gov