Status:
COMPLETED
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia A
Eligibility:
All Genders
Brief Summary
The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor...
Eligibility Criteria
Inclusion
- 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.
- Diagnosis of haemophilia A in males or females, no age limitation.
- New patients who have not previously been exposed to Esperoct®.
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Known or suspected hypersensitivity to study product or related products.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04334057
Start Date
March 31 2021
End Date
January 10 2024
Last Update
August 29 2025
Active Locations (19)
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1
Kurume University Hospital, Pediatrics
Fukuoka, Japan, 830-0011
2
Gifu University Hospital
Gifu, Japan, 501-1194
3
Saitama Medical University Hospital, Pediatrics
Iruma-gun, Saitama, Japan, 350 0495
4
University Hospital Kyoto Prefectual University of Medicine
Kamigyo-ku, Kyoto, Japan, 602-8566