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A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
Sponsor: Novo Nordisk A/S
Summary
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.
Official title: A Non-Interventional Post-Authorisation Safety Study (PASS) in Male Haemophilia B Patients Receiving Nonacog Beta Pegol (N9-GP) Prophylaxis Treatment
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2019-04-01
Completion Date
2027-12-15
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
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
Locations (29)
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
Cliniques universitaires Saint-Luc - Service Hématologie
Brussels, Belgium
UZ Antwerpen - UZA - Kinderhemato-Oncologie
Edegem, Belgium
UZ Leuven - Hart en Vaatziekten
Leuven, Belgium
University of Calgary Cumming School of Medicine
Calgary, Alberta, Canada
Univ of Alberta Hospital Res
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Health Science Centre
St. John's, Newfoundland and Labrador, Canada
Hamilton Health Sciences Corp, Ontario
Hamilton, Ontario, Canada
Hamltn Hth Sci/McMstr Child Hosp
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
KBC Zagreb, Rebro, Hemofilija centar
Zagreb, Croatia
FN Brno odd. hematologie
Brno, Czechia
Fakultni nemocnice Plzen - Lochotin
Pilsen, Czechia
Skejby Blodsygdomme, blødercentret
Aarhus N, Denmark
Helsinki University Central Hospital/Coagulation Disorder Un
Helsinki, Finland
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, Germany
"Laiko" General Hospital of Athens
Athens, Greece
"Laiko" General Hospital of Athens
Athens, Greece
Aghia Sophia Childrens' Hospital
Athens, Greece
Klinisk forskningspost
Oslo, Norway
Hospital São José
Lisbon, Portugal
Unidade Local de Saúde São José EPE- Hospital D. Estefânia
Lisbon, Portugal
Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Switzerland
Aberdeen Royal Infirmary - Haematology
Aberdeen, United Kingdom
University Hospital of Wales - Haemophilia
Cardiff, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom