NCT03745924

A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN

A Non-Interventional Post-Authorisation Safety Study (PASS) in Male Haemophilia B Patients Receiving Nonacog Beta Pegol (N9-GP) Prophylaxis Treatment

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant's participation in the study will last for 4-9 years, depending on when they join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

Conditions

• Haemophilia B

Interventions

Type	Name	Description
DRUG	Nonacog beta pegol	Participants are treated with commercially available nonacog beta pegol (N9-GP) according to local clinical practice at the discretion of the treating physician

Timeline

• Start date: 2019-04-01
• Primary completion: 2027-12-15
• Completion: 2027-12-15
• First posted: 2018-11-19
• Last updated: 2025-12-22

Locations

29 sites across 13 countries: Austria, Belgium, Canada, Croatia, Czechia, Denmark, Finland, Germany, Greece, Norway, Portugal, Switzerland, United Kingdom