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
- Interventions
- Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
- Registration Number
- NCT04461639
- Lead Sponsor
- Bayer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Damoctocog alfa pegol Damoctocog alfa pegol (Jivi, BAY94-9027) Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.
- Primary Outcome Measures
Name Time Method 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 with outcome of death 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 related to inhibitor development At least 4 years
- Secondary Outcome Measures
Name Time Method Change from baseline in aspartate aminotransferase (AST) At least 4 years Change from baseline in creatinine At least 4 years Change from baseline in alanine transaminase (ALT) At least 4 years Number of adverse reactions (ARs) related to hepatic or renal function At least 4 years Testing for PEG plasma levels (baseline and end of study) At least 4 years 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.
Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders At least 4 years Change from baseline in estimated glomerular filtration rate (eGFR) At least 4 years Change from baseline in bilirubin At least 4 years Number of patients with abnormal findings as assessed by neurological examination At least 4 years
Trial Locations
- Locations (1)
Many Locations
🇪🇸Multiple Locations, Spain