Status: FinalisedLast updated on: 16/06/2017
1. Study identification
EU PAS Register NumberEUPAS12387
Official titleMulticenter prospective open-label non-interventional uncontrolled Post-Authorisation Safety Study (PASS) to evaluate the safety profile of Polyoxidonium in daily practice
Study title acronym
Study typeObservational study
Brief description of the studyThis PASS aims to collect data on the safety of Polyoxidonium in patients, for whom Polyoxidonium is prescribed in routine practice in accordance with the terms of the marketing authorisation (MA). This is a local, multicenter, prospective, open-label, non-interventional, uncontrolled study. The decision to prescribe Polyoxidonium will be independent of the decision to enrol the subject into the study. Each subject will be observed for the duration of one cycle of Polyoxidonium treatment. In accordance with the SmPC, the treatment course consists of 5-10 injections depending on the disease. Thus, study duration for individual subject will take 7-23 days. There will be 5-10 study visits coinciding with routine visits to receive Polyoxidonium injections at the health care centre. Actual assessments undertaken at each visit will be determined by clinical practice. Subjects will not be administered any investigational medicinal products and/or medical procedures neither undergo any laboratory evaluations, diagnostic or monitoring procedures specifically for the purposes of this study.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameMEDIGROUP s.r.o.
Centre locationMlynské Nivy 54 821 05 Bratislava, Slovakia
Details of (Primary) lead investigator
Title Professor
Last name Pruzinec
First name Peter
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?15
Countries in which this study is being conducted
National study

Slovakia
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/07/201528/07/2015
Start date of data collection16/05/201620/06/2016
Start date of data analysis02/01/201710/02/2017
Date of interim report, if expected
Date of final study report29/03/201708/05/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNPO PETROVAXPHARM100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Pruzinec
First name Peter
Address line 1Tabaková 1
Address line 2 
Address line 3 
CityBratislava 
Postcode821 07 
CountrySlovakia
Phone number (incl. country code)421905658777 
Alternative phone number 
Fax number (incl. country code) 
Email address peter@bonusccs.sk
Public Enquiries
Title Ms 
Last name Tutlyte 
First name Indre 
Address line 1Savanoriu 109 
Address line 2 
Address line 3 
CityKaunas 
Postcode44208 
CountryLithuania 
Phone number (incl. country code)37037366307 
Alternative phone number 
Fax number (incl. country code) 
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