Status:
TERMINATED
A Study to Learn More About Treatment With Damoctocog Alfa Pegol, How it is Used in Every Day Practice ("Real-World"), and How Satisfied People Who Receive Damoctocog Alfa Pegol Are in United States (US) Hemophilia Treatment Centers
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
All Genders
12+ years
Brief Summary
People with hemophilia A do not have enough of a protein found naturally in the blood called "clotting factor 8", also known as FVIII. This protein helps the blood to clump together to prevent and sto...
Eligibility Criteria
Inclusion
- Male or female with a diagnosis of hemophilia A
- Previously or currently treated with damoctocog alfa pegol for at least 6 months.
- Treated with damoctocog alfa pegol per the US approved label to include:
- Aged ≥12 years at the time of damoctocog alfa pegol treatment initiation
- Previously treated for hemophilia A with an FVIII replacement therapy other than damoctocog alfa pegol
- Treatment modality of on-demand, prophylactic, intermittent prophylaxis or a combination thereof
- Have data in the medical record at the participating site as follows:
- For a minimum of 6 months prior to the damoctocog alfa pegol initiation date
- For a minimum of 6 months post-damoctocog alfa pegol initiation date AND the patient was receiving treatment with damoctocog alfa pegol during this 6-month follow-up period AND this data is dated prior to the central institutional review board (IRB) approval date for the study
- To include the FVIII replacement therapy most recently received prior to the initiation of damoctocog alfa pegol
- For patients in the prospective cohort
- Signed informed consent
- Current treatment with damoctocog alfa pegol or discontinued use of damoctocog alfa pegol within 3 months prior to the date of enrollment into the retrospective cohort.
Exclusion
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- Participation in any past or current damoctocog alfa pegol interventional trial.
Key Trial Info
Start Date :
January 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05395858
Start Date
January 17 2023
End Date
November 6 2023
Last Update
November 28 2023
Active Locations (3)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
Tulane University
New Orleans, Louisiana, United States, 70112
3
Regents of the University of Minnesota
Minneapolis, Minnesota, United States, 55455