An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism
NCT ID: NCT06278051
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
320 participants
OBSERVATIONAL
2024-02-19
2024-11-11
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Xarelto (Rivaroxaban, BAY59-7939)
Rivaroxaban granules for oral suspension
Treatment dose and period decided by its prescription
Warfarin
Warfarin
Treatment dose and period decided by its prescription
Interventions
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Rivaroxaban granules for oral suspension
Treatment dose and period decided by its prescription
Warfarin
Treatment dose and period decided by its prescription
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of VTE at any point before and including the index date
* Receiving a prescription/dispensation of rivaroxaban or warfarin
Exclusion Criteria
0 Months
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.)
UNKNOWN
Bayer
INDUSTRY
Responsible Party
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Locations
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Many facilities
Multiple Locations, , Japan
Bayer
Osaka, , Japan
Countries
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Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Other Identifiers
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21411
Identifier Type: -
Identifier Source: org_study_id