Trial Condition(s):

Hemophilia A

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 Identifier:

20904

ClinicalTrials.gov Identifier:

NCT04461639

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

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 Summary

Enrollment Goal
50
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Germany

Status
Recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Recruiting
 
Locations

Many Locations

Many Locations, Italy

Status
Recruiting
 
Locations

Many Locations

Many Locations, Austria

Status
Recruiting
 
Locations

Many Locations

Many Locations, Greece

Status
Recruiting
 
Locations

Many Locations

Many Locations, Slovenia

Status
Recruiting
 
Locations

Many Locations

Many Locations, Russia

Status
Not yet recruiting
 

Trial Design