ThrombosisPhase 1NCT02497716
Phase I Study on Rivaroxaban Granules for Oral Suspension Formulation in Children
A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939 in people with Thrombosis, run by Bayer at 21 sites in 8 countries.
Trial summary
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 4 Nov 2015to 22 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
United States5 sites
Carolinas Healthcare System
Charlotte, North Carolina, 28204
Nationwide Children's Hospital
Columbus, Ohio, 43205-2696
Riley Hospital For Children
Indianapolis, Indiana, 46202
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital Oakland
Oakland, California, 94609
Canada4 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Italy3 sites
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
A.O. di Padova
Padova, Veneto, 35128
A.O.U. Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126
Spain3 sites
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital de Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Finland2 sites
HUS Lastenklinikka
HUS, 00029
Turun yliopistollinen keskussairaala, kantasairaala
Turku, 20520
France2 sites
Hôpital Arnaud de Villeneuve - Montpellier
Montpellier, 34059
Hopital Necker les enfants malades - Paris
Paris, 75015
About this study
Official title: Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
- Conditions
- Thrombosis
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939Drug
Single dose of reconstituted rivaroxaban granules
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Single arm, open label study Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the curve)
Only PK will be tested in central lab
Measured: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Cmax (maximum observed drug concentration)
Only PK will be tested in central lab
Measured: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Secondary outcomes (3)
Prothrombin time (PT)
Measured: Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Activated partial thromboplastin time (aPTT)
Measured: Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Composite of major bleeding and clinically relevant non-major bleeding
Measured: From dose administration until follow up call on day 8+3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start4 Nov 2015
- Primary completion22 May 2018
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497716
- Sponsor's protocol ID
- 17992
- Other IDs
- 2015-000962-76, 2015
- Status last verified
- Apr 2019
- First submitted
- 12 Jul 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
- ClinicalTrials.gov ID
- NCT02497716
- Acronym / sponsor ID
- 17992
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: Rivaroxaban (Xarelto, BAY59-7939Single arm, open label study |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Normal PT and aPTT within 10 days prior to planned study drug administration
- Written informed consent provided and, if applicable, child assent provided
Key exclusion criteria (14 listed)
- 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:
- Platelet count < 50 x 10^9/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939Single dose of reconstituted rivaroxaban granules | Drug | Rivaroxaban |
Primary outcome
AUC (area under the curve)
Time frame: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Only PK will be tested in central lab
Cmax (maximum observed drug concentration)
Time frame: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Only PK will be tested in central lab
3 secondary outcomes
Prothrombin time (PT)
Time frame: Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Activated partial thromboplastin time (aPTT)
Time frame: Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration
Composite of major bleeding and clinically relevant non-major bleeding
Time frame: From dose administration until follow up call on day 8+3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban (Xarelto, BAY59-7939 in people with Thrombosis, run by Bayer at 21 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, Italy, Spain, Finland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (area under the curve) (time frame: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.