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 (HA-SAFE)

Bayer

Status: Active, not recruiting

Conditions: Hemophilia A

Treatments: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Study type: Observational

Funder types: Industry

Identifiers

NCT04461639

20904

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

62 participants in 1 patient group

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.

Treatment:

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)