A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorBayer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial population
The study should be conduct on hemophilia A patients who are prescribed with Jivi (damoctocog alfa pegol) as sole treatment for an approved indication (the treatment and prophylaxis of bleeding in PTPs aged ≥ 12 years with hemophilia A (congenital FVIII deficiency)) by the Ministry of Food and Drug Safety (MFDS) in Korea.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Damoctocog-alfa-pegol (Jivi, BAY94-9027)
DrugFollow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Post-marketing surveillance cohort1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of adverse events (AEs)
Number of participants with AEs
Time frame
Up to 36 weeks2
Occurrence of Serious adverse events (SAEs)
Number of participants with SAEs
Time frame
Up to 36 weeks3
Occurrence of adverse reactions (ARs)
Number of participants with ARs
Time frame
Up to 36 weeks4
Occurrence of Serious adverse reactions (SARs)
Number of participants with SARs
Time frame
Up to 36 weeksSecondary outcomes
1
Annualized number of reported total bleeds
Time frame
Up to 36 weeks2
Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)
Time frame
Up to 36 weeks3
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 months4
Regimen selection determinants (physician and patient)
Time frame
Up to 36 weeksLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Many LocationsRecruiting Multiple LocationsSouth Korea
Source ClinicalTrials.gov