Trial Review

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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
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
Trial website
https://clinicaltrials.gov/study/NCT02497716
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02497716