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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45024
• 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

F. Hoffmann-La Roche

Study timelines

Date when funding contract was signed

Actual: 24/08/2018

Study start date

Planned: 08/01/2020

Actual: 12/02/2020

Data analysis start date

Actual: 15/01/2021

Date of final study report

Planned: 30/09/2021

Actual: 22/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche, Ltd.

Study protocol

Initial protocol

Prot BO40853 Emicizumab v2_Redacted

Updated protocol

Prot BO40853 emicizumab v3_Redacted

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)

Other study registration identification numbers and links

BO40853