Brief Title
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
Official Title
A Multinational, Prospective, Open Labelled, Non-controlled, Non-interventional Post-authorisation Study of Turoctocog Alfa Pegol (N8-GP) During Long-term Routine Prophylaxis and Treatment of Bleeding Episodes in Patients With Haemophilia A
Brief Summary
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants 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.
Study Type
Observational
Primary Outcome
Number of Adverse Events (AEs) reported during the study period
Secondary Outcome
Number of Serious Adverse Events (SAEs) reported during the study period
Condition
Haemophilia A
Intervention
Turoctocog alfa pegol (N8-GP)
Study Arms / Comparison Groups
N8-GP
Description: Patients with haemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
October 23, 2020
Completion Date
June 3, 2027
Primary Completion Date
June 3, 2027
Eligibility Criteria
Inclusion Criteria: - Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). - The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. - Male patients of all ages, according to local label, are allowed in this study - Diagnosis of severe or moderate Haemophilia A Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Known or suspected hypersensitivity to N8-GP or related products - Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation - Clinical suspicion or presence of FVIII inhibitors at time of inclusion
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Transparency (1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT04574076
Organization ID
NN7088-4029
Secondary IDs
EUPAS36536
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Transparency (1452), Study Director, Novo Nordisk A/S
Verification Date
March 2022