Venous ThromboembolismNCT06278051
An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism
An observational study of Venous Thromboembolism, run by Bayer at 2 sites in Japan.
Trial summary
This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors. Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins. Read more about this study
- Who is it for?
- Ages 0 months to 18 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Rivaroxaban granules for oral suspension and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 320 participants
- Where
- 2 sitesJapan
- Study dates
- 19 Feb 2024to 11 Nov 2024
- Phase
- Observational
- 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 0 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with pediatric VTE treated with rivaroxaban or warfarin in real-world clinical practice in Japan between 01 January 2021 and 30 June 2024
Who may be able to join
None listed.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Post-Marketing Database Study for Rivaroxaban in Patients With Pediatric VTE
This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.
Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.
Read more
The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting.
Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.
A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.
The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor.
In addition, this study will help learn more about the following in children with VTE:
- The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin
- The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding
- The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban
- The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors.
The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024.
Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban granules for oral suspension, Warfarin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban granules for oral suspensionDrug
Also called Xarelto, BAY59-7939
Treatment dose and period decided by its prescription
WarfarinDrug
Treatment dose and period decided by its prescription
| Study group | Role | What they receive |
|---|---|---|
| Xarelto (Rivaroxaban, BAY59-7939) | Not described Receives: Drug: Rivaroxaban granules for oral suspension | |
| Warfarin | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major bleeding in participants treated with rivaroxaban
Major bleeding is defined as composite of composite of intracranial hemorrhage, intraocular bleeding, upper gastrointestinal bleeding, lower gastrointestinal bleeding, bleeding requiring for blood transfusion
Measured: Retrospective analysis from January 2021 to June 2024
Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban
Characteristics and demographics of participants will include e.g., age and gender, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medication. They will be described.
Measured: Retrospective analysis from January 2021 to June 2024
Secondary outcomes (3)
Incidence of major bleeding in participants treated with warfarin
Major bleeding is defined as composite of composite of intracranial hemorrhage, intraocular bleeding, upper gastrointestinal bleeding, lower gastrointestinal bleeding, bleeding requiring for blood transfusion
Measured: Retrospective analysis from 01 January 2021 to 30 June 2024
Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference
Bleeding important in pediatrics is defined as composite of pulmonary hemorrhage, renal hemorrhage, hypermenorrhea
Measured: Retrospective analysis from 01 January 2021 to 30 June 2024
Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups
target patient groups:
- concomitant use with anti-platelet agents and NSAIDs
- concomitant use with CYP3A4 inhibitors
- impaired renal function
- long term administration
- other oral anti-coagulants administration prior to rivaroxaban
Measured: Retrospective analysis from 01 January 2021 to 30 June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start19 Feb 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278051
- Sponsor's protocol ID
- 21411
- Status last verified
- May 2026
- First submitted
- 19 Feb 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Individual data sharing
- No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Database Study for Rivaroxaban in Patients With Pediatric VTE
- ClinicalTrials.gov ID
- NCT06278051
- Acronym / sponsor ID
- 21411
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- 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.
This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors.
Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins.
The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting.
Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug.
A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.
The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor.
In addition, this study will help learn more about the following in children with VTE:
- The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin
- The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding
- The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban
- The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors.
The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024.
Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period.
In this study, only available data from routine care are collected. No visits or tests are required as part of this study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xarelto (Rivaroxaban, BAY59-7939) | – | Drug: Rivaroxaban granules for oral suspension |
| Warfarin | – | Drug: Warfarin |
Who may qualify
- Ages
- 0 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with pediatric VTE treated with rivaroxaban or warfarin in real-world clinical practice in Japan between 01 January 2021 and 30 June 2024
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- none
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 granules for oral suspensionAlso: Xarelto, BAY59-7939Treatment dose and period decided by its prescription | Drug | Xarelto (Rivaroxaban, BAY59-7939) |
| WarfarinTreatment dose and period decided by its prescription | Drug | Warfarin |
Primary outcome
Incidence of major bleeding in participants treated with rivaroxaban
Time frame: Retrospective analysis from January 2021 to June 2024
Major bleeding is defined as composite of composite of intracranial hemorrhage, intraocular bleeding, upper gastrointestinal bleeding, lower gastrointestinal bleeding, bleeding requiring for blood transfusion
Clinical characteristics and demographics of participants with pediatric VTE treated with rivaroxaban
Time frame: Retrospective analysis from January 2021 to June 2024
Characteristics and demographics of participants will include e.g., age and gender, diagnosis and prior treatment, past medical history, concomitant diseases, and concomitant medication. They will be described.
3 secondary outcomes
Incidence of major bleeding in participants treated with warfarin
Time frame: Retrospective analysis from 01 January 2021 to 30 June 2024
Incidence of bleeding important in pediatrics in participants treated with rivaroxaban and treated with warfarin as reference
Time frame: Retrospective analysis from 01 January 2021 to 30 June 2024
Incidence of major bleeding and bleeding important in pediatrics in participants treated with rivaroxaban and in special target patient groups
Time frame: Retrospective analysis from 01 January 2021 to 30 June 2024
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 12 May 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Bayer at 2 sites in Japan.
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 0 inclusion and 1 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
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?
Incidence of major bleeding in participants treated with rivaroxaban (time frame: Retrospective analysis from January 2021 to June 2024). 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 12 May 2026.