Study identification

EU PAS number

EUPAS33520

Study ID

42361

Official title and acronym

Observational study evaluating long-term safety of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A (HA-SAFE)

DARWIN EU® study

No

Study countries

Austria
Belgium
Denmark
Finland
Germany
Greece
Italy
Luxembourg
Netherlands
Norway
Portugal
Slovenia
Spain
Sweden
Switzerland

Study description

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 pegolis) 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 to prevent bleeding at their treating doctors. 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 status

Ongoing
Research institutions and networks

Institutions

Bayer AG
First published:
01/02/2024
Institution

Contact details

Bayer Clinical Trials BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/PSP/S/0070