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

Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients 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.

Study Overview

• Status: Recruiting
• Conditions: Hemophilia A; Prophylaxis of Bleeding; Treatment of Bleeding
• Intervention / Treatment: Drug: Damoctocog-alfa-pegol (Jivi, BAY94-9027)

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of
    • Recruiting
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A; Hemorrhage; Coagulants; Factor VIII
• Other Study ID Numbers: 21278 (NARSAD Young Investigator Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No