A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

Inclusion Criteria: - =12 years of age with hemophilia A - Previously treated with FVIII concentrate(s) (plasma derived or recombinant) - Patients for whom the decision to initiate treatment with Jivi (damoctocog alfa pegol) was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.) - Written informed consent from subject or legal representative; assent from subject when appropriate Exclusion Criteria: - Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein)) - Patients participating in an investigational program with interventions outside of routine clinical practice - Patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia A - Patients on immune tolerance induction treatment at the time of enrollment

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (AEs);Occurrence of Serious adverse events (SAEs);Occurrence of adverse reactions (ARs);Occurrence of Serious adverse reactions (SARs);Occurrence of adverse events of important identified risks (AESIs);Number of adverse events related to overdose;Number of adverse events related to previously taken drugs and concomitant drugs

Secondary Outcome Measures

Name	Time	Method
Annualized number of reported total bleeds;Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol);Difference annualized total/average factor consumption (for overall, prophylaxis, bleeds(Intermittent prophylaxis), and other events) from previous FVIII products versus Jivi (damoctocog alfa pegol);Regimen selection determinants (physician and patient);Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment;ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study