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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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 - 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
Primary outcome [1] 0 0
AUC (area under the curve)
Timepoint [1] 0 0
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Primary outcome [2] 0 0
Cmax (maximum observed drug concentration)
Timepoint [2] 0 0
4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Secondary outcome [1] 0 0
Prothrombin time (PT)
Timepoint [1] 0 0
Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Secondary outcome [2] 0 0
Activated partial thromboplastin time (aPTT)
Timepoint [2] 0 0
Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Secondary outcome [3] 0 0
Composite of major bleeding and clinically relevant non-major bleeding
Timepoint [3] 0 0
From dose administration until follow up call on day 8+3

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
N/A
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)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Finland
State/province [9] 0 0
HUS
Country [10] 0 0
Finland
State/province [10] 0 0
Turku
Country [11] 0 0
France
State/province [11] 0 0
Montpellier
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Piemonte
Country [16] 0 0
Italy
State/province [16] 0 0
Veneto
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

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
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for
suspension formulation and to document safety and tolerability
Trial website
https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT02497716