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

Study Overview
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Brief Summary
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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.

Official Title
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Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Damoctocog alfa pegol<br>Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice. | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe | At least 4 years | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders |  | At least 4 years | 
| Number of adverse reactions (ARs) related to hepatic or renal function |  | At least 4 years | 
| Change from baseline in creatinine |  | At least 4 years | 
| Change from baseline in estimated glomerular filtration rate (eGFR) |  | At least 4 years | 
| Change from baseline in alanine transaminase (ALT) |  | At least 4 years | 
| Change from baseline in aspartate aminotransferase (AST) |  | At least 4 years | 
| Change from baseline in bilirubin |  | At least 4 years | 
| Testing for PEG plasma levels (baseline and end of study) | PEG (Polyethylene Glycol)-plasma levels at baseline and end of study will be analyzed only if PEG-plasma levels were collected in local routine clinical practice at the investigator's discretion. | At least 4 years | 
| Number of patients with abnormal findings as assessed by neurological examination |  | At least 4 years |