Study identification

EU PAS number

EUPAS30451

Study ID

45024

Official title and acronym

Hemlibra Survey to Prescribers and Patients/Carers to Evaluate Awareness, Knowledge and Compliance to Additional Risk Minimization Measures

DARWIN EU® study

No

Study countries

Austria
Belgium
Czechia
France
Germany
Hungary
Italy
Netherlands
Poland
Portugal
Romania
Spain
United Kingdom

Study description

The study will utilize anonymous, cross-sectional, multinational surveys conducted among prescribers (health care providers HCPs) and patients with haemophilia A receiving Hemlibra, or their carers, in European countries, using primary data collection in the form of online questionnaires. The surveys to HCPs and patients/carers will assess their awareness of the Hemlibra educational program, knowledge of important identified risks (thrombotic microangiopathy TMA and thrombotic events TEs) and important potential life-threatening risk of bleeding due to misinterpretation of the standard coagulation tests associated with Hemlibra use, and adherence to additional risk minimization measures. Only relevant HCPs that have treated haemophilia patients with Hemlibra at least once outside of clinical trials will be targeted for the survey. Patients/carers will be recruited via their physicians.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Nives Selak Bienz

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche, Ltd.
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)