Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
- Conditions
- Haemophilia A
- Interventions
- Registration Number
- NCT04682145
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Participation in the European Haemophilia Safety Surveillance System (EUHASS).
Exclusion Criteria
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Haemophilia A patients Turoctocog alfa pegol All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
- Primary Outcome Measures
Name Time Method 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. From start to end of data collection (December 2019 to January 2025) Count
- Secondary Outcome Measures
Name Time Method Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A From start to end of data collection (December 2019 to January 2025) Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events).
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Søborg, Denmark