Brief Title
A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
Official Title
A Non-Interventional Post-Authorisation Safety Study (PASS) in Male Haemophilia B Patients Receiving Nonacog Beta Pegol (N9-GP) Prophylaxis Treatment
Brief 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.
Study Type
Observational
Primary Outcome
Number of Adverse Drug Reactions (ADRs) (FIX inhibitors, allergic reactions, and thromboembolic events)
Secondary Outcome
Number of Serious Adverse Events (SAEs)
Condition
Haemophilia B
Intervention
Nonacog beta pegol
Study Arms / Comparison Groups
Patients with haemophilia B
Description: Patients with haemophilia B without current inhibitors
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
April 1, 2019
Completion Date
December 15, 2027
Primary Completion Date
December 15, 2027
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - Previous participation in this study. Participation is defined as signed informed consent - Known or suspected hypersensitivity to N9-GP or related products - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation - Clinical suspicion or presence of FIX inhibitor at time of inclusion.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Reporting Anchor and Disclosure (1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03745924
Organization ID
NN7999-4031
Secondary IDs
U1111-1165-8657
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor and Disclosure (1452), Study Director, Novo Nordisk A/S
Verification Date
January 2021