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ACTIVE NOT RECRUITING
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

Sponsor: Bayer

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

62

Start Date

2021-05-14

Completion Date

2028-06-30

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

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

Locations (6)

Many Locations

Multiple Locations, Austria

Many Locations

Multiple Locations, Germany

Many Locations

Multiple Locations, Greece

Many Locations

Multiple Locations, Italy

Many Locations

Multiple Locations, Slovenia

Many Locations

Multiple Locations, Spain