Brief Title
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
Official Title
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
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. The study will last for about 2 years for each participant.
Study Type
Observational
Primary Outcome
Number of adverse reactions (ARs) reported during the observation period
Secondary Outcome
Number of serious adverse events (SAEs) reported during the observation period
Condition
Haemophilia A
Intervention
Turoctocog alfa pegol
Study Arms / Comparison Groups
Patients with haemophilia A
Description: New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.
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
15
Start Date
March 31, 2021
Completion Date
February 28, 2025
Primary Completion Date
February 28, 2025
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.
Gender
All
Ages
N/A - N/A
Contacts
Clinical Reporting Anchor & Disclosure (1452), ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT04334057
Organization ID
NN7088-4484
Secondary IDs
U1111-1216-4626
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor & Disclosure (1452), Study Director, Novo Nordisk A/S
Verification Date
February 2022