In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study. Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments. Through this study, researchers want to learn more about its safety in a real-world setting. The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information. The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment. Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits. In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
Study Type
OBSERVATIONAL
Enrollment
20
Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.
Many Locations
Multiple Locations, South Korea
RECRUITINGOccurrence of adverse events (AEs)
Number of participants with AEs
Time frame: Up to 36 weeks
Occurrence of Serious adverse events (SAEs)
Number of participants with SAEs
Time frame: Up to 36 weeks
Occurrence of adverse reactions (ARs)
Number of participants with ARs
Time frame: Up to 36 weeks
Occurrence of Serious adverse reactions (SARs)
Number of participants with SARs
Time frame: Up to 36 weeks
Occurrence of adverse events of important identified risks (AESIs)
Important identified risks include development of Factor VIII inhibitors/Hypersensitivity/Clinical response characterised by lack of drug effect associated with anti-polyehtylene glycol (PEG) antibodies.
Time frame: Up to 36 weeks
Number of adverse events related to overdose
Time frame: Up to 36 weeks
Number of adverse events related to previously taken drugs and concomitant drugs
Time frame: Up to 36 weeks
Annualized number of reported total bleeds
Time frame: Up to 36 weeks
Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)
Time frame: Up to 36 weeks
Difference annualized total/average factor consumption (for overall, prophylaxis, bleeds(Intermittent prophylaxis), and other events) from previous FVIII products versus Jivi (damoctocog alfa pegol)
Time frame: Up to 36 months
Regimen selection determinants (physician and patient)
Time frame: Up to 36 weeks
Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment
Time frame: Up to 36 weeks
ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study
ABR stands for annualized bleeding rate.
Time frame: Up to 36 weeks
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