NCT03875547

Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Post-marketing Surveillance (Use Result Surveillance) With Refixia®. A Multicentre, Non-interventional Post Marketing Surveillance of Safety and Effectiveness of Refixia® in Routine Clinical Care With Haemophilia B Patients in Japan.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B. The participants will get Refixia® as prescribed to them by their study doctor. The study will last up to Sep 2025 for the participant. The participants may be asked to fill in the quality of life questionnaires (if they are above age of 15). The blood samples taken from the participants as part of routine clinical practice will also be used to investigate the safety for the long-term use of Refixia®.

Conditions

• Haemophilia B

Interventions

Type	Name	Description
DRUG	Refixia®	Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician

Timeline

• Start date: 2019-08-23
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2019-03-14
• Last updated: 2026-03-27

Locations

23 sites across 2 countries: Denmark, Japan