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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02497716
Ethics application status
Date submitted
12/07/2015
Date registered
12/07/2015
Date last updated
11/05/2018

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) - Only PK will be tested in central lab
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) - Only PK will be tested in central lab
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
Gender
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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - 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
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Austria
State/province [8] 0 0
Steiermark
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Finland
State/province [13] 0 0
HUS
Country [14] 0 0
Finland
State/province [14] 0 0
Turku
Country [15] 0 0
France
State/province [15] 0 0
Montpellier
Country [16] 0 0
France
State/province [16] 0 0
Nantes
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin
Country [20] 0 0
Italy
State/province [20] 0 0
Lombardia
Country [21] 0 0
Italy
State/province [21] 0 0
Piemonte
Country [22] 0 0
Italy
State/province [22] 0 0
Veneto
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Sevilla
Country [26] 0 0
Sweden
State/province [26] 0 0
Stockholm

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/show/NCT02497716
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
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

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