Clinical trial NCT06222697: A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
Official title: Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemophilia A
Prophylaxis of Bleeding
Treatment of Bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events (AEs)
timeFrame: Up to 36 weeks
measure: Occurrence of Serious adverse events (SAEs)
timeFrame: Up to 36 weeks
measure: Occurrence of adverse reactions (ARs)
timeFrame: Up to 36 weeks
measure: Occurrence of Serious adverse reactions (SARs)
timeFrame: Up to 36 weeks
measure: Occurrence of adverse events of important identified risks (AESIs)
timeFrame: Up to 36 weeks
measure: Number of adverse events related to overdose
timeFrame: Up to 36 weeks
measure: Number of adverse events related to previously taken drugs and concomitant drugs
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Annualized number of reported total bleeds
timeFrame: Up to 36 weeks
measure: Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)
timeFrame: Up to 36 weeks
measure: Difference annualized total/average factor consumption (for overall, prophylaxis, bleeds(Intermittent prophylaxis), and other events) from previous FVIII products versus Jivi (damoctocog alfa pegol)
timeFrame: Up to 36 months
measure: Regimen selection determinants (physician and patient)
timeFrame: Up to 36 weeks
measure: Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment
timeFrame: Up to 36 weeks
measure: ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
Study officials:
References: