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
- Conditions
- Hemophilia A
- Registration Number
- NCT04461639
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Signed informed consent/assent will be obtained before any study-related activities<br><br> - PTPs with hemophilia A assigned to Jivi prophylaxis treatment<br><br> - Negative FVIII inhibitor test before study entry<br><br> - Decision to initiate treatment with commercially available Jivi has been made by the<br> treating physician before and independently from the decision to include the patient<br> in this study<br><br>Exclusion Criteria:<br><br> - Known or suspected contraindications to Jivi or related products<br><br> - Mental incapacity, unwillingness or other barriers precluding adequate understanding<br> or cooperation<br><br> - Participation in an investigational program with interventions outside of routine<br> clinical practice
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with safety events;Duration of safety events;Number of participants with safety events leading to a change of treatment;Number of participants with safety events per intensity;Number of participants with safety events with outcome of death;Number of participants with safety events related to inhibitor development
- Secondary Outcome Measures
Name Time Method Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders;Number of adverse reactions (ARs) related to hepatic or renal function;Change from baseline in creatinine;Change from baseline in estimated glomerular filtration rate (eGFR);Change from baseline in alanine transaminase (ALT);Change from baseline in aspartate aminotransferase (AST);Change from baseline in bilirubin;Testing for PEG plasma levels (baseline and end of study);Number of patients with abnormal findings as assessed by neurological examination