Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04682145
Collaborator
(none)
50
1
51.7
1
Study Details
Study Description
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 alfapegol. There is no extra burden to the patients by participating in this registry-based data collection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Actual Study Start Date
:
Dec 9, 2020
Anticipated Primary Completion Date
:
Apr 1, 2025
Anticipated Study Completion Date
:
Apr 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Haemophilia A patients All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS |
Drug: Turoctocog alfa pegol
Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol 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 the registry in scope.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Participation in the European Haemophilia Safety Surveillance System (EUHASS).
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Søborg | Denmark | 2860 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor & Disclosure (2834), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04682145
Other Study ID Numbers:
- NN7088-4557
- U1111-1235-5939
First Posted:
Dec 23, 2020
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: