Status: Finalised First registered on: 20/05/2019
Last updated on: 05/05/2020
1. Study identification
EU PAS Register NumberEUPAS29813
Official titleEvaluation 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 title acronym
Study typeOther: Survey
Brief description of the studyObizur® (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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research groupReal World Insights
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name von Bredow
First name Dorothea
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
Germany
Italy
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/12/201715/12/2017
Start date of data collection01/07/201930/09/2019
Start date of data analysis15/01/202026/11/2019
Date of interim report, if expected
Date of final study report31/03/202006/03/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Page
First name Matt
Address line 1Takeda Pharmaceutical Company Limited
Address line 2650 East Kendall Street 
Address line 3 
CityCambridge 
Postcode02142 
CountryUnited States
Phone number (incl. country code)16175888613 
Alternative phone number 
Fax number (incl. country code) 
Email address matt.page@takeda.com
Public Enquiries
Title Dr 
Last name Page 
First name Matt 
Address line 1Takeda Pharmaceutical Company Limited 
Address line 2650 East Kendall Street 
Address line 3 
CityCambridge 
Postcode02142 
CountryUnited States 
Phone number (incl. country code)16175888613 
Alternative phone number 
Fax number (incl. country code) 
Email address matt.page@takeda.com 
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