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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02309411




Registration number
NCT02309411
Ethics application status
Date submitted
24/11/2014
Date registered
5/12/2014
Date last updated
21/08/2018

Titles & IDs
Public title
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
Scientific title
30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis
Secondary ID [1] 0 0
2014-000566-22
Secondary ID [2] 0 0
14374
Universal Trial Number (UTN)
Trial acronym
EINSTEINJr
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)

Experimental: 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


Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
Timepoint [1] 0 0
During or within 2 days after stop of study treatment (up to 32 days)
Secondary outcome [1] 0 0
Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
Timepoint [1] 0 0
From start of the study treatment up to 30-days post study treatment period (approximately 60 days)
Secondary outcome [2] 0 0
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
Timepoint [2] 0 0
At the end of the 30-day treatment period
Secondary outcome [3] 0 0
Change From Baseline in Prothrombin Time at Specified Time Points
Timepoint [3] 0 0
Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
Secondary outcome [4] 0 0
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
Timepoint [4] 0 0
Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)
Secondary outcome [5] 0 0
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Timepoint [5] 0 0
Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)

Eligibility
Key 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
Minimum age
6 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2017
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Israel
State/province [10] 0 0
Jerusalem
Country [11] 0 0
Israel
State/province [11] 0 0
Ramat Gan
Country [12] 0 0
Italy
State/province [12] 0 0
Lombardia
Country [13] 0 0
Italy
State/province [13] 0 0
Piemonte
Country [14] 0 0
Italy
State/province [14] 0 0
Veneto
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Netherlands
State/province [16] 0 0
Nijmegen
Country [17] 0 0
Poland
State/province [17] 0 0
Gdansk
Country [18] 0 0
Poland
State/province [18] 0 0
Olsztyn
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Moscow
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Nizhny Novgorod
Country [21] 0 0
Russian Federation
State/province [21] 0 0
St. Petersburg
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Valencia
Country [24] 0 0
Switzerland
State/province [24] 0 0
Bern
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Tyne And Wear
Country [26] 0 0
United Kingdom
State/province [26] 0 0
West Midlands
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02309411