Brief Title
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Official Title
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Brief Summary
This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.
Study Type
Observational
Primary Outcome
Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events.
Secondary Outcome
Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A
Condition
Haemophilia A
Intervention
Turoctocog alfa pegol
Study Arms / Comparison Groups
Haemophilia A patients
Description: All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
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
50
Start Date
December 9, 2020
Completion Date
April 1, 2025
Primary Completion Date
April 1, 2025
Eligibility Criteria
Inclusion Criteria: - Participation in the European Haemophilia Safety Surveillance System (EUHASS). Exclusion Criteria: - N/A
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Reporting Anchor & Disclosure (2834), ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04682145
Organization ID
NN7088-4557
Secondary IDs
U1111-1235-5939
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor & Disclosure (2834), Study Director, Novo Nordisk A/S
Verification Date
January 2023