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NCT Number: 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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Prophylaxis of Bleeding Treatment of Bleeding

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.

Primary outcomes

  1. Occurrence of adverse events (AEs)

    Time frame: Up to 36 weeks

    Number of participants with AEs

  2. Occurrence of Serious adverse events (SAEs)

    Time frame: Up to 36 weeks

    Number of participants with SAEs

  3. Occurrence of adverse reactions (ARs)

    Time frame: Up to 36 weeks

    Number of participants with ARs

  4. Occurrence of Serious adverse reactions (SARs)

    Time frame: Up to 36 weeks

    Number of participants with SARs

  5. Occurrence of adverse events of important identified risks (AESIs)

    Time frame: 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.

  6. Number of adverse events related to overdose

    Time frame: Up to 36 weeks

  7. Number of adverse events related to previously taken drugs and concomitant drugs

    Time frame: Up to 36 weeks

Secondary outcomes

  1. Annualized number of reported total bleeds

    Time frame: Up to 36 weeks

  2. Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)

    Time frame: Up to 36 weeks

  3. 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 months

  4. Regimen selection determinants (physician and patient)

    Time frame: Up to 36 weeks

  5. Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment

    Time frame: Up to 36 weeks

  6. ABR during the study compared with ABR for previous FVIII products in the 12 months prior to enrollment into the study

    Time frame: Up to 36 weeks

    ABR stands for annualized bleeding rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 25, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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