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

NCT ID NCT03745924

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

First seen Jan 04, 2026 · Last updated Jun 23, 2026 · Updated 25 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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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

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.

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