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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02497716




Registration number
NCT02497716
Ethics application status
Date submitted
12/07/2015
Date registered
14/07/2015
Date last updated
16/04/2019

Titles & IDs
Public title
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
Scientific title
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
Secondary ID [1] 0 0
2015-000962-76
Secondary ID [2] 0 0
17992
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombosis 0 0
Condition category
Condition code

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

Experimental: Rivaroxaban - Single arm, open label study


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939
Single dose of reconstituted rivaroxaban granules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Children with an age =2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.

* Gestational age at birth of at least 37 weeks
* Oral feeding/ nasogastric/ gastric feeding for at least 10 days
* Normal PT and aPTT within 10 days prior to planned study drug administration
* Written informed consent provided and, if applicable, child assent provided
Minimum age
2 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
* Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
* An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
* Hepatic disease which is associated either with:

* coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (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 systolic and/or diastolic blood pressure >95th percentile for age)
* Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
* Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Inability to cooperate with the study procedures
* Hypersensitivity to rivaroxaban
* Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
* History of gastrointestinal disease or surgery associated with impaired absorption

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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 1
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
4/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/05/2018
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02497716