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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03745924
Other study ID # NN7999-4031
Secondary ID U1111-1165-8657E
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date December 15, 2027

Study information

Verified date January 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date December 15, 2027
Est. primary completion date December 15, 2027
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
Austria AKH - Klin. Abt. f. Haematologie u. Haemostaseologie Wien
Belgium Cliniques universitaires Saint-Luc - Service Hématologie Bruxelles
Canada University of Calgary Cumming School of Medicine Calgary Alberta
Canada Univ of Alberta Hospital Res Edmonton Alberta
Canada Hamilton Health Sciences Corp, Ontario Hamilton Ontario
Canada Hamltn Hth Sci/McMstr Child Hosp Hamilton Ontario
Canada Health Science Centre St. John's Newfoundland and Labrador
Canada The Hospital for Sick Children Toronto Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
Croatia KBC Zagreb, Rebro, Hemofilija centar Zagreb
Czechia FN Brno odd. hematologie Brno
Czechia Fakultni nemocnice Plzen - Lochotin Plzen
Denmark Skejby Blodsygdomme, blødercentret Aarhus N
Finland Helsinki University Central Hospital/Coagulation Disorder Un Helsinki
Germany Vivantes Klinikum am Friedrichshain Berlin
Germany Rheinische Friedrich-Wilhelms-Universität Bonn Bonn
Greece "Laiko" General Hospital of Athens Athens
Greece Aghia Sophia Childrens' Hospital Athens
Norway Klinisk forskningspost Oslo
Portugal Centro Hospitalar Lisboa Central - Hospital Dona Estefânia Lisboa
Portugal Hospital São José Lisboa
United Kingdom Aberdeen Royal Infirmary - Haematology Aberdeen
United Kingdom Arthur Bloom Haemophilia Centre Cardiff
United Kingdom Royal Manchester Children's Hospital Manchester
United Kingdom Royal Hallamshire Hospital Sheffield

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Drug Reactions (ADRs) (FIX inhibitors, allergic reactions, and thromboembolic events) Count of events From start of study period (week 0) to end of study period (up to 9 years)
Secondary Number of Serious Adverse Events (SAEs) Count of events From start of study period (week 0) to up to 9 years
Secondary Number of bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR) Count of episodes From start of study period (week 0) to up to 9 years
Secondary Number of treatment requiring bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR) Number of episodes From start of study period (week 0) to up to 9 years
Secondary Haemostatic effect of N9-GP when used for treatment of bleeding episodes Count of bleeding episodes. Haemostatic effect is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure From start of study period (week 0) to up to 9 years
Secondary Haemostatic response of N9-GP when used in perioperative management Count of bleeding episodes. Haemostatic response is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure From start of study period (week 0) to end of study period (up to 9 years)
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