CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Rivaroxaban (Xarelto, BAY59-7939)drug
Likely dose
Rivaroxaban (Xarelto, BAY59-7939) 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02564718
NCT02564718Phase 2Completed
CompareCT.gov

7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis

Bayer·interventional·Posted Oct 1, 2015·Updated Jul 10, 2018

In Brief

A Phase 2 clinical trial evaluating Rivaroxaban (Xarelto, BAY59-7939) for Thromboembolism. Completed, enrolled 10 participants across 9 sites in 7 countries.

Detailed Summary

The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism
CountriesAustria, France, Germany, Israel, Italy, Spain, Turkey (Türkiye)
CollaboratorsJanssen Research & Development, LLC

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 1, 2015
Enrollment StartNov 19, 2015
Primary CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.8 years ago

Interventions

Rivaroxaban (Xarelto, BAY59-7939)drug

Body weight adjusted dosing of rivaroxaban to achieve a similar exposure in the range as that observed in adults treated for venous thromboembolism (VTE) with 20 mg once daily.