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

NCT ID: NCT03745924

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2027-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with haemophilia B

Patients with haemophilia B without current inhibitors

Nonacog beta pegol

Intervention Type DRUG

Participants are treated with commercially available nonacog beta pegol (N9-GP) according to local clinical practice at the discretion of the treating physician

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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

Vienna, , Austria

Site Status

Cliniques universitaires Saint-Luc - Service Hématologie

Brussels, , Belgium

Site Status

UZ Antwerpen - UZA - Kinderhemato-Oncologie

Edegem, , Belgium

Site Status

UZ Leuven - Hart en Vaatziekten

Leuven, , Belgium

Site Status

University of Calgary Cumming School of Medicine

Calgary, Alberta, Canada

Site Status

Univ of Alberta Hospital Res

Edmonton, Alberta, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Health Science Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Hamilton Health Sciences Corp, Ontario

Hamilton, Ontario, Canada

Site Status

Hamltn Hth Sci/McMstr Child Hosp

Hamilton, Ontario, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

KBC Zagreb, Rebro, Hemofilija centar

Zagreb, , Croatia

Site Status

FN Brno odd. hematologie

Brno, , Czechia

Site Status

Fakultni nemocnice Plzen - Lochotin

Pilsen, , Czechia

Site Status

Skejby Blodsygdomme, blødercentret

Aarhus N, , Denmark

Site Status

Helsinki University Central Hospital/Coagulation Disorder Un

Helsinki, , Finland

Site Status

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status

Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

Bonn, , Germany

Site Status

"Laiko" General Hospital of Athens

Athens, , Greece

Site Status

"Laiko" General Hospital of Athens

Athens, , Greece

Site Status

Aghia Sophia Childrens' Hospital

Athens, , Greece

Site Status

Klinisk forskningspost

Oslo, , Norway

Site Status

Hospital São José

Lisbon, , Portugal

Site Status

Unidade Local de Saúde São José EPE- Hospital D. Estefânia

Lisbon, , Portugal

Site Status

Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

Zurich, , Switzerland

Site Status

Aberdeen Royal Infirmary - Haematology

Aberdeen, , United Kingdom

Site Status

University Hospital of Wales - Haemophilia

Cardiff, , United Kingdom

Site Status

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Countries

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Austria Belgium Canada Croatia Czechia Denmark Finland Germany Greece Norway Portugal Switzerland United Kingdom

Other Identifiers

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U1111-1165-8657

Identifier Type: OTHER

Identifier Source: secondary_id

EUPAS26592

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN7999-4031

Identifier Type: -

Identifier Source: org_study_id