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 | Recruiting

• 1 other identifier: 21278
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A; Prophylaxis of Bleeding; Treatment of Bleeding

Outcome Measures

Primary Outcomes (7)

• Occurrence of adverse events (AEs)

  Number of participants with AEs

  Up to 36 weeks

• Occurrence of Serious adverse events (SAEs)

  Number of participants with SAEs

  Up to 36 weeks

• Occurrence of adverse reactions (ARs)

  Number of participants with ARs

  Up to 36 weeks

• Occurrence of Serious adverse reactions (SARs)

  Number of participants with SARs

  Up to 36 weeks

• 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

• 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

Secondary Outcomes (6)

• 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

Study Arms (1)

Post-marketing surveillance cohort

Participants follow their usual medical visits with data collection occurs continuously in a 36-week observational period.

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

Interventions

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.

Post-marketing surveillance cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, South Korea

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 25, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)