Follows men with haemophilia B using Refixia during long-term treatment
Follows men with haemophilia B who receive nonacog beta pegol for prevention.
Plain-language title generated from the registry record
Registry title: A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
Key facts
- Where
- Vienna, AustriaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for males of any age who have haemophilia B and are starting N9-GP (Refixia/REBINYN) preventive treatment. Everyone keeps the treatment their own doctor gives them.
- Age
- Any age
- Sex
- Males only
- Disease stage
- Haemophilia B
- Earlier treatment
- The patient and the doctor have decided to start commercially available N9-GP treatment, before and apart from the decision to join this study.
Main reasons for not taking part
- Took part in this study before
- Known or suspected allergy to N9-GP or related products
- Mental incapacity, unwillingness or language barriers that prevent understanding or cooperation
- Suspected or present FIX inhibitor when joining
Read by machine on 12 November 2026.
Where in Austria
- AKH - Klin. Abt. f. Haematologie u. HaemostaseologieVienna, AustriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT03745924
- Record updated
- 12 June 2026
- Original description
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.Read full original descriptionShow less
A Non-Interventional Post-Authorisation Safety Study (PASS) in Male Haemophilia B Patients Receiving Nonacog Beta Pegol (N9-GP) Prophylaxis Treatment
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.
Inclusion: Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol); Male patients at any age with haemophilia B assigned to N9-GP prophylaxis treatment; Decision to initiate treatment with commercially available N9-GP has been made by the patient(s)/Legally Authorised Representative(s) (LAR(s)) and the treating physician before and independently from the decision to include the patient in this study.
Exclusion: Previous participation in this study. Participation is defined as signed informed consent; Clinical suspicion or presence of FIX inhibitor at time of inclusion; Known or suspected hypersensitivity to N9-GP or related products; Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.