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

June 11, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc - Service Hématologie
      • Edegem, Belgium, 2650
        • UZ Antwerpen - UZA - Kinderhemato-Oncologie
      • Leuven, Belgium, 3000
        • UZ Leuven - Hart en Vaatziekten
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary Cumming School of Medicine
      • Edmonton, Alberta, Canada, T6G 2V2
        • Univ of Alberta Hospital Res
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Health Science Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences Corp, Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamltn Hth Sci/McMstr Child Hosp
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
  • Croatia
      • Zagreb, Croatia, 10 000
        • KBC Zagreb_Hematology
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Brno, Czechia, 625 00
        • FN Brno odd. hematologie
      • Pilsen, Czechia, 304 60
        • Fakultni nemocnice Plzen - Lochotin
  • Denmark
      • Aarhus N, Denmark, 8200
        • Skejby Blodsygdomme, blødercentret
  • Finland
      • Helsinki, Finland, 00290
        • Coagulation Disorder Unit
  • Germany
      • Berlin, Germany, 10249
        • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
  • Greece
      • Athens, Greece, 11527
        • "Laiko" General Hospital of Athens
      • Athens, Greece, GR-11527
        • "Laiko" General Hospital of Athens
      • Athens, Greece, GR-11527
        • Aghia Sophia Childrens' Hospital
  • Norway
      • Oslo, Norway, 0372
        • Klinisk forskningspost
  • Portugal
      • Lisbon, Portugal, 1169-045
        • ULS De São José, E.P.E.- Hospital D. Estefânia
      • Lisbon, Portugal, 1150-199
        • ULS De São José, E.P.E - Hospital São José_Serviço de Imunohemoterapia
  • Switzerland
      • Zurich, Switzerland, 8091
        • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary - Haematology
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales - Haemophilia
      • Manchester, United Kingdom, M13 9WL
        • Royal Manchester Children's Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia B

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with haemophilia B
Patients with haemophilia B without current inhibitors
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Drug Reactions (ADRs) (FIX inhibitors, allergic reactions, and thromboembolic events)
Time Frame: From start of study period (week 0) to end of study period (up to 9 years)
Count of events
From start of study period (week 0) to end of study period (up to 9 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events (SAEs)
Time Frame: From start of study period (week 0) to up to 9 years
Count of events
From start of study period (week 0) to up to 9 years
Number of bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR)
Time Frame: From start of study period (week 0) to up to 9 years
Count of episodes
From start of study period (week 0) to up to 9 years
Number of treatment requiring bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR)
Time Frame: From start of study period (week 0) to up to 9 years
Number of episodes
From start of study period (week 0) to up to 9 years
Haemostatic effect of N9-GP when used for treatment of bleeding episodes
Time Frame: From start of study period (week 0) to up to 9 years
Count of bleeding episodes. Haemostatic effect is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
From start of study period (week 0) to up to 9 years
Haemostatic response of N9-GP when used in perioperative management
Time Frame: From start of study period (week 0) to end of study period (up to 9 years)
Count of bleeding episodes. Haemostatic response is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
From start of study period (week 0) to end of study period (up to 9 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN7999-4031
  • U1111-1165-8657 (Other Identifier: World Health Organization (WHO))
  • EUPAS26592 (Registry Identifier: EU PAS Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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