Study identification

PURI

https://redirect.ema.europa.eu/resource/104927

EU PAS number

EUPAS46800

Study ID

104927

Official title and acronym

Xarelto Paediatric VTE PASS Drug Utilization Study: An observational, longitudinal, multi-source drug utilization safety study to evaluate the drug use patterns and safety of rivaroxaban oral suspension in children under two years with venous thromboembolism (XAPAEDUS)

DARWIN EU® study

No

Study countries

Denmark
France
Spain
Sweden

Study description

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: Age, gender, and other information about the child and their illness. Type of VTE treatment given to the child. Occurrence of medically important bleeding and its severity. Further information that researchers will collect: Changes in the characteristics of the children given VTE treatment (e.g. changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE. Return of VTE symptoms. Types of doctors who prescribe VTE treatment and their set-up (e.g. special clinics versus hospitals). Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until the child has a bleeding episode, VTE symptoms return, VTE treatment ends, or death, their information is no longer available, or the study ends.

Study status

Planned
Research institution and networks

Institutions

Bayer AG
First published:
01/02/2024
Institution

Contact details

Bayer Clinical Trials Contact BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Study protocol
Initial protocol

22195_Study Protocol_Redacted_V2.1_2022-11-16

English (735.21 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)