NCT04461639

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	Damoctocog alfa pegol (Jivi, BAY94-9027)	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

Timeline

• Start date: 2021-05-14
• Primary completion: 2027-03-31
• Completion: 2028-06-30
• First posted: 2020-07-08
• Last updated: 2026-04-09

Locations

6 sites across 6 countries: Austria, Germany, Greece, Italy, Slovenia, Spain