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Clinical Trials in South Korea / NCT06222697
Recruiting Observational

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

NCT06222697 · tracked via the Priya Life Science South Korea tracker
Sponsor
Bayer
Phase
Observational
Started
2024-01-24
Last updated
2026-06-22

Condition(s) studied

Hemophilia AProphylaxis of BleedingTreatment of Bleeding

Investigational drug(s) / intervention(s)

Damoctocog-alfa-pegol (Jivi, BAY94-9027) →

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

Study 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

Sex
ALL
Min age
12 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Many Locations Multiple Locations South Korea Recruiting

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Other trials for the same condition

A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A Active, not recruiting
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A Recruiting
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B Recruiting
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors Recruiting
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06222697 on ClinicalTrials.gov ↗ ← All trials in South Korea