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Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®. A Multi-centre, Prospective, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Esperoct® in Haemophilia A Patients Under Routine Clinical Practice Conditions in Japan

ID
Name
NN7088-4484
Description
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. The study will last for about 2 years for each participant.
Trial arms
Trial start
2021-03-31
Estimated PCD
2025-02-28
Trial end
2025-02-28
Treatment
Turoctocog alfa pegol
Patients will be treated with commercially available Esperoct® according to routine clinical practice at the discretion of the treating physician. 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.
Arms:
Patients with haemophilia A
Size
15
Primary endpoint
Number of adverse reactions (ARs) reported during the observation period
From baseline (week 0) to end of study (week 104)
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. * Diagnosis of haemophilia A in males or females, no age limitation. * New patients who have not previously been exposed to Esperoct®. Exclusion Criteria: * 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2023-11-28

1 organization

1 product

1 indication

Organization
Novo Nordisk
Product
Turoctocog alfa pegol
Indication
Hemophilia A