NCT03745924Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 15 Nov 2018
- Start date
- 1 Apr 2019
- Primary completion date
- 15 Dec 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT03745924
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Apr 2019 to the primary completion date, 15 Dec 2027
- 29 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as signed informed consent
- Clinical suspicion or presence of FIX inhibitor at time of inclusion.
Other illness
- Known or suspected hypersensitivity to N9-GP or related products
Other
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Cliniques universitaires Saint-Luc - Service Hématologie Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Antwerpen - UZA - Kinderhemato-Oncologie Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| UZ Leuven - Hart en Vaatziekten Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| University of Calgary Cumming School of Medicine Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Univ of Alberta Hospital Res Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Hamilton Health Sciences Corp, Ontario Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Hamltn Hth Sci/McMstr Child Hosp Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Health Science Centre Coordinator of this site? Confirm its status | St. John's | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| FN Brno odd. hematologie Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Fakultni nemocnice Plzen - Lochotin Coordinator of this site? Confirm its status | Pilsen | Czechia | Unknown status |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Skejby Blodsygdomme, blødercentret Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Coagulation Disorder Unit Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Aberdeen Royal Infirmary - Haematology Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| University Hospital of Wales - Haemophilia Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Aghia Sophia Childrens' Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| KBC Zagreb_Hematology Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Klinisk forskningspost Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| ULS De São José, E.P.E - Hospital São José_Serviço de Imunohemoterapia Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| ULS De São José, E.P.E.- Hospital D. Estefânia Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.