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

Hemophilia A Clinical Trial

Official title:

Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222697
• Other study ID #: 21278
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Hemorrhage

Intervention

Drug:
• Damoctocog-alfa-pegol (Jivi, BAY94-9027)
Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.

Locations

Country	Name	City	State
Korea, Republic of	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events (AEs)	Number of participants with AEs	Up to 36 weeks
Primary	Occurrence of Serious adverse events (SAEs)	Number of participants with SAEs	Up to 36 weeks
Primary	Occurrence of adverse reactions (ARs)	Number of participants with ARs	Up to 36 weeks
Primary	Occurrence of Serious adverse reactions (SARs)	Number of participants with SARs	Up to 36 weeks
Primary	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.	Up to 36 weeks
Primary	Number of adverse events related to overdose		Up to 36 weeks
Primary	Number of adverse events related to previously taken drugs and concomitant drugs		Up to 36 weeks
Secondary	Annualized number of reported total bleeds		Up to 36 weeks
Secondary	Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)		Up to 36 weeks
Secondary	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
Secondary	Regimen selection determinants (physician and patient)		Up to 36 weeks
Secondary	Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment		Up to 36 weeks
Secondary	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.	Up to 36 weeks

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