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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

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
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ViennaAustriaUnknown status
Cliniques universitaires Saint-Luc - Service Hématologie
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BrusselsBelgiumUnknown status
UZ Antwerpen - UZA - Kinderhemato-Oncologie
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EdegemBelgiumUnknown status
UZ Leuven - Hart en Vaatziekten
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LeuvenBelgiumUnknown status
University of Calgary Cumming School of Medicine
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CalgaryCanadaUnknown status
Univ of Alberta Hospital Res
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EdmontonCanadaUnknown status
Hamilton Health Sciences Corp, Ontario
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HamiltonCanadaUnknown status
Hamltn Hth Sci/McMstr Child Hosp
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HamiltonCanadaUnknown status
Health Science Centre
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St. John'sCanadaUnknown status
The Hospital for Sick Children
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TorontoCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
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ZurichSwitzerlandUnknown status
FN Brno odd. hematologie
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BrnoCzechiaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaUnknown status
Fakultni nemocnice Plzen - Lochotin
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PilsenCzechiaUnknown status
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
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BerlinGermanyUnknown status
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
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BonnGermanyUnknown status
Skejby Blodsygdomme, blødercentret
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Aarhus NDenmarkUnknown status
Coagulation Disorder Unit
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HelsinkiFinlandUnknown status
Aberdeen Royal Infirmary - Haematology
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AberdeenUnited KingdomUnknown status
University Hospital of Wales - Haemophilia
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CardiffUnited KingdomUnknown status
Royal Manchester Children's Hospital
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ManchesterUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Aghia Sophia Childrens' Hospital
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AthensGreeceUnknown status
Laiko General Hospital of Athens
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AthensGreeceUnknown status
KBC Zagreb_Hematology
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ZagrebCroatiaUnknown status
Klinisk forskningspost
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OsloNorwayUnknown status
ULS De São José, E.P.E - Hospital São José_Serviço de Imunohemoterapia
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LisbonPortugalUnknown status
ULS De São José, E.P.E.- Hospital D. Estefânia
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LisbonPortugalUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.