An Observational Study to Learn More About How Safe Treatment With Rivaroxaban is in Children in Japan With Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title:

Post-Marketing Database Study for Rivaroxaban in Patients With Pediatric VTE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278051
• Other study ID #: 21411
• Status: Recruiting
• Start date: February 19, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 18 Years

Eligibility

Inclusion Criteria:At index date, which is the date of first prescription of rivaroxaban or of warfarin during the study period

• Age less than 18 years

• Diagnosis of VTE at any point before and including the index date

• Receiving a prescription/dispensation of rivaroxaban or warfarin

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban granules for oral suspension
Treatment dose and period decided by its prescription
• Warfarin
Treatment dose and period decided by its prescription

Locations

Country	Name	City	State
Japan	Many facilities	Multiple Locations
Japan	Bayer	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Pharmaceutical Companies (formerly Johnson & Johnson Pharmaceutical Research & Development L.L.C.)

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Retrospective analysis from January 2021 to June 2024
Primary	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.	Retrospective analysis from January 2021 to June 2024
Secondary	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	Retrospective analysis from 01 January 2021 to 30 June 2024
Secondary	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	Retrospective analysis from 01 January 2021 to 30 June 2024
Secondary	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	Retrospective analysis from 01 January 2021 to 30 June 2024

External Links

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