EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

NCT ID: NCT02309411

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-15
• Study Completion Date: 2017-04-05

Brief Summary

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays 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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rivaroxaban

Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant

Interventions

Rivaroxaban (Xarelto, BAY59-7939)

With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children aged 6 months to < 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
• Informed consent provided

Exclusion Criteria

• Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
• Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
• Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
• An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
• Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
• Platelet count < 50 x 10*9/L
• Hypertension defined as > 95th age percentile
• Life expectancy < 3 months
• Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
• Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
• Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
• Inability to cooperate with the study procedures
• Previous randomization to this study
• Participation in a study with an investigational drug or medical device within 30 days prior to randomization

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Gainesville, Florida, United States

Pensacola, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Parkville, Victoria, Australia

Vienna, , Austria

São Paulo, São Paulo, Brazil

São Paulo, , Brazil

Toronto, Ontario, Canada

Budapest, , Hungary

Jerusalem, , Israel

Ramat Gan, , Israel

Milan, Lombardy, Italy

Turin, Piedmont, Italy

Padua, Veneto, Italy

Setagaya City, Tokyo, Japan

Nijmegen, , Netherlands

Gdansk, , Poland

Olsztyn, , Poland

Moscow, , Russia

Nizhny Novgorod, , Russia

Saint Petersburg, , Russia

Barcelona, , Spain

Valencia, , Spain

Bern, , Switzerland

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Birmingham, West Midlands, United Kingdom

Cardiff, , United Kingdom

Countries

United States; Australia; Austria; Brazil; Canada; Hungary; Israel; Italy; Japan; Netherlands; Poland; Russia; Spain; Switzerland; United Kingdom

References

Monagle P, Lensing AWA, Thelen K, Martinelli I, Male C, Santamaria A, Samochatova E, Kumar R, Holzhauer S, Saracco P, Simioni P, Robertson J, Grangl G, Halton J, Connor P, Young G, Molinari AC, Nowak-Gottl U, Kenet G, Kapsa S, Willmann S, Pap AF, Becka M, Twomey T, Beyer-Westendorf J, Prins MH, Kubitza D; EINSTEIN-Jr Phase 2 Investigators. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. Lancet Haematol. 2019 Oct;6(10):e500-e509. doi: 10.1016/S2352-3026(19)30161-9. Epub 2019 Aug 13.

Reference Type: DERIVED

PMID: 31420317 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2014-000566-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14374

Identifier Type: -

Identifier Source: org_study_id