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Researchers track real-world safety of haemophilia b drug over nearly a decade

NCT ID NCT03745924

Knowledge-focused Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 60 males with haemophilia B who are already using the drug Refixia (nonacog beta pegol) to prevent bleeding. Researchers will collect information on side effects, bleeding episodes, and quality of life over 4 to 9 years. No new treatment is given—participants continue their usual care. The goal is to better understand the long-term safety and effectiveness of this medication in everyday use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nonacog beta pegol (Refixia/REBINYN)
What this could lead to
If successful, this study will confirm the long-term safety and effectiveness of Refixia for preventing bleeds in haemophilia B patients.
What could go wrong
This is an observational study, not a test of a new treatment. It only collects data from routine care, so it cannot prove new benefits or risks beyond what is already known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with haemophilia B

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemophilia B

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Laiko" General Hospital of Athens

    Athens, 11527, Greece

  • "Laiko" General Hospital of Athens

    Athens, GR-11527, Greece

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Vienna, 1090, Austria

  • Aberdeen Royal Infirmary - Haematology

    Aberdeen, AB25 2ZN, United Kingdom

  • Aghia Sophia Childrens' Hospital

    Athens, GR-11527, Greece

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Cliniques universitaires Saint-Luc - Service Hématologie

    Brussels, 1200, Belgium

  • Coagulation Disorder Unit

    Helsinki, 00290, Finland

  • FN Brno odd. hematologie

    Brno, 625 00, Czechia

  • Fakultni nemocnice Plzen - Lochotin

    Pilsen, 304 60, Czechia

  • Fakultní nemocnice Brno

    Brno, 625 00, Czechia

  • Hamilton Health Sciences Corp, Ontario

    Hamilton, Ontario, L8N 3Z5, Canada

  • Hamltn Hth Sci/McMstr Child Hosp

    Hamilton, Ontario, L8N 3Z5, Canada

  • Health Science Centre

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • KBC Zagreb_Hematology

    Zagreb, 10 000, Croatia

  • Klinisk forskningspost

    Oslo, 0372, Norway

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL, United Kingdom

  • Skejby Blodsygdomme, blødercentret

    Aarhus N, 8200, Denmark

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • ULS De São José, E.P.E - Hospital São José_Serviço de Imunohemoterapia

    Lisbon, 1150-199, Portugal

  • ULS De São José, E.P.E.- Hospital D. Estefânia

    Lisbon, 1169-045, Portugal

  • UZ Antwerpen - UZA - Kinderhemato-Oncologie

    Edegem, 2650, Belgium

  • UZ Leuven - Hart en Vaatziekten

    Leuven, 3000, Belgium

  • Univ of Alberta Hospital Res

    Edmonton, Alberta, T6G 2V2, Canada

  • University Hospital of Wales - Haemophilia

    Cardiff, CF14 4XW, United Kingdom

  • University of Calgary Cumming School of Medicine

    Calgary, Alberta, T2N 2T9, Canada

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127, Germany

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091, Switzerland

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

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