Status:
ACTIVE_NOT_RECRUITING
Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
All Genders
12+ years
Brief Summary
In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VII...
Eligibility Criteria
Inclusion
- Signed informed consent/assent will be obtained before any study-related activities
- PTPs with hemophilia A assigned to Jivi prophylaxis treatment
- Negative FVIII inhibitor test before study entry
- Decision to initiate treatment with commercially available Jivi has been made by the treating physician before and independently from the decision to include the patient in this study
Exclusion
- Known or suspected contraindications to Jivi or related products
- Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation
- Participation in an investigational program with interventions outside of routine clinical practice
Key Trial Info
Start Date :
May 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2028
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04461639
Start Date
May 14 2021
End Date
June 30 2028
Last Update
December 30 2025
Active Locations (6)
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1
Many Locations
Multiple Locations, Austria
2
Many Locations
Multiple Locations, Germany
3
Many Locations
Multiple Locations, Greece
4
Many Locations
Multiple Locations, Italy