Brief Title
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
Official Title
Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
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.
Study Type
Observational
Primary Outcome
Number of participants with safety events
Secondary Outcome
Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders
Condition
Hemophilia A
Intervention
Damoctocog alfa pegol (Jivi, BAY94-9027)
Study Arms / Comparison Groups
Damoctocog alfa pegol
Description: Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
June 30, 2021
Completion Date
June 30, 2028
Primary Completion Date
June 30, 2028
Eligibility Criteria
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
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, (+)1-888-84 22937, [email protected]
Administrative Informations
NCT ID
NCT04461639
Organization ID
20904
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
, ,
Verification Date
February 2021