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

Recruiting

• Conditions: Treatment of Bleeding; Prophylaxis of Bleeding; Hemophilia A
• Interventions: Drug: Damoctocog-alfa-pegol (Jivi, BAY94-9027)

• Registration Number: NCT06222697
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-15
• Study Start: 2024-01-24
• Study First Posted: 2024-01-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-03-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-marketing surveillance cohort	Damoctocog-alfa-pegol (Jivi, BAY94-9027)	Participants follow their usual medical visits with data collection occurs continuously in a 36-week observational period.

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (AEs)	Up to 36 weeks	Number of participants with AEs
Number of adverse events related to overdose	Up to 36 weeks
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 previously taken drugs and concomitant drugs	Up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Many Locations; 🇰🇷 Multiple Locations, Korea, Republic of