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Hemophilia A, Prophylaxis of bleeding, Treatment of bleeding

Bayer Identifier:

21278

ClinicalTrials.gov Identifier:

NCT06222697

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about the safety of damoctocog-alfa-pegol when used in routine medical care in Korean participants with hemophilia A

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

12 - N/A
  • - ≥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
  • - 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

Trial summary

Enrollment Goal
600
Trial Dates
January 2024 - June 2026
Phase
Phase 4
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Korea,_republic_of

Primary Outcome

  • Occurrence of adverse events (AEs)
    Number of participants with AEs
    date_rangeTime Frame:
    Up to 36 weeks
  • Occurrence of Serious adverse events (SAEs)
    Number of participants with SAEs
    date_rangeTime Frame:
    Up to 36 weeks
  • Occurrence of adverse reactions (ARs)
    Number of participants with ARs
    date_rangeTime Frame:
    Up to 36 weeks
  • Occurrence of Serious adverse reactions (SARs)
    Number of participants with SARs
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 36 weeks
  • Number of adverse events related to overdose
    date_rangeTime Frame:
    Up to 36 weeks
  • Number of adverse events related to previously taken drugs and concomitant drugs
    date_rangeTime Frame:
    Up to 36 weeks

Secondary Outcome

  • Annualized number of reported total bleeds
    date_rangeTime Frame:
    Up to 36 weeks
  • Difference in annualized total number of injections, injection frequency from previous FVIII products versus Jivi (damoctocog alfa pegol)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Up to 36 months
  • Regimen selection determinants (physician and patient)
    date_rangeTime Frame:
    Up to 36 weeks
  • Number of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 36 weeks

Trial design

Post marketing surveillance study for Jivi (damoctocog alfa pegol) in Korean patients with Hemophilia A
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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