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
Damoctocog alfa pegol (Jivi, BAY94-9027): Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice
Study 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 VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Number of participants with safety events — At least 4 years
Duration of safety events — At least 4 years
Number of participants with safety events leading to a change of treatment — At least 4 years
Number of participants with safety events per intensity — At least 4 years The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe
Number of participants with safety events with outcome of death — At least 4 years
Number of participants with safety events related to inhibitor development — At least 4 years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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