Hemophilia A, Prophylaxis of Bleeding, Treatment of Bleeding
Conditions
Brief summary
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.
Interventions
DRUGDamoctocog-alfa-pegol (Jivi, BAY94-9027)
Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥12 years of age with hemophilia A * Previously treated with FVIII concentrate(s) (plasma derived or recombinant) * Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events (AEs) | Up to 36 weeks | Number of participants with AEs |
| Occurrence of Serious adverse events (SAEs) | Up to 36 weeks | Number of participants with SAEs |
| Occurrence of adverse reactions (ARs) | Up to 36 weeks | Number of participants with ARs |
| Occurrence of Serious adverse reactions (SARs) | Up to 36 weeks | Number of participants with SARs |
| Occurrence of adverse events of important identified risks (AESIs) | Up to 36 weeks | 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. |
| Number of adverse events related to overdose | Up to 36 weeks | — |
| Number of adverse events related to previously taken drugs and concomitant drugs | Up to 36 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized number of reported total bleeds | Up to 36 weeks | — |
| Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol) | 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) | Up to 36 months | — |
| Regimen selection determinants (physician and patient) | Up to 36 weeks | — |
| Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment | 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 | Up to 36 weeks | ABR stands for annualized bleeding rate. |
Countries
South Korea
Contacts
CONTACTBayer Clinical Trials Contact
Outcome results
None listed