Status: Ongoing First registered on: 19/04/2019
Last updated on: 30/01/2020
1. Study identification
EU PAS Register NumberEUPAS29462
Official titleA Prospective, Multicentre, Non-interventional, Observational, Post-authorisation Safety Study of Ropeginterferon alfa-2b in Polycythaemia Vera Patients
Study title acronymBesremi-PASS
Study typeObservational study
Brief description of the studyThe objective of the study is to provide further data to characterize the safety and tolerability of ropeginterferon alfa-2b by monitoring the hepatic and cardiovascular safety in patients with polycythaemia vera treated with ropeginterferon alfa-2b in routine post-authorisation use.
Was this study requested by a regulator?Yes: EMA
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 nameAOP Orphan Pharmaceuticals AG
Centre locationVienna, Austria
Details of (Primary) lead investigator
Title Dr
Last name AOP Orphan Pharmaceuticals AG
First name Clinical Trial Disclosure
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?25
Countries in which this study is being conducted
International study

Austria
Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/04/2019
Start date of data collection31/12/201917/12/2019
Start date of data analysis31/03/2023
Date of interim report, if expected31/03/2022
Date of final study report29/09/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAOP Orphan Pharmaceuticals AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name AOP Orphan Pharmaceuticals AG
First name Clinical Trial Disclosure
Address line 1Wilhelminenstraße 91/IIf
Address line 2 
Address line 3 
CityVienna 
Postcode1160 
CountryAustria
Phone number (incl. country code)431503724410 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Klade 
First name Christoph 
Address line 1Wilhelminenstraße 91/IIf 
Address line 2 
Address line 3 
CityVienna 
Postcode1160 
CountryAustria 
Phone number (incl. country code)431503724410 
Alternative phone number 
Fax number (incl. country code) 
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