Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge on Dosing and Administration of Obizur® (Susoctocog alfa) in 6 European Countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48511
• EU PAS number:
  EUPAS29813
• Study ID:
  48511
• Official title and acronym:
  Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge on Dosing and Administration of Obizur® (Susoctocog alfa) in 6 European Countries
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Netherlands

  Sweden

  United Kingdom
• Study description:
  Obizur® (susoctocog alfa) is indicated in adults for treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII (AHA). The overall research question is to evaluate whether healthcare professionals (HCPs) expected to prescribe or dispense Obizur have been successfully informed by the educational materials regarding the method of calculation and administration of Obizur. Study design: This is a cross-sectional, multinational web based survey conducted in 6 selected European countries (Belgium, Germany, Italy, Netherlands, Sweden, UK) among HCPs who treat patients with AHA and may be involved in prescribing, dose calculation, and dispensing of Obizur and were targeted to receive the educational materials. Population The study will be conducted among HCPs (physicians, nurses, pharmacists) who treat patients with AHA or may be involved in dose calculation or dispensing of Obizur. Data Sources The survey will involve primary data collection conducted through web questionnaire or phone. In order to address the study objectives, the following information will be collected: • Information on participating HCPs (demographics, HCP subgroup, specialty, setting) • Information on participating HCPs’ awareness of the educational materials (recollecting receiving the educational materials, awareness of content, knowledge of content) • For HCPs who have prescribed, calculated the dose of, or dispensed Obizur: information on patients (characteristics, administered and calculated dose, reasons for deviations from recommended dose). Study Size The target sample size for this study is 100 HCPs. Such a sample would allow the description of an unknown proportion of correct answers to any of the survey questions with a precision of 9.8% for a 95% confidence interval. Achievement of the sample size will depend on the number of HCPs who have received the educational materials.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 15/12/2017

Actual: 15/12/2017

Study start date

Planned: 01/07/2019

Actual: 30/09/2019

Data analysis start date

Planned: 15/01/2020

Actual: 26/11/2019

Date of final study report

Planned: 31/03/2020

Actual: 06/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)