Multicenter prospective open-label non-interventional uncontrolled Post-Authorisation Safety Study (PASS) to evaluate the safety profile of Polyoxidonium in daily practice

Study identification

• EU PAS number:
  EUPAS12387
• Study ID:
  19533
• Official title and acronym:
  Multicenter prospective open-label non-interventional uncontrolled Post-Authorisation Safety Study (PASS) to evaluate the safety profile of Polyoxidonium in daily practice
• DARWIN EU® study:
  No
• Study countries:
  Slovakia
• Study description:
  This 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

MEDIGROUP s.r.o.

Multiple centres: 15 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:28/07/2015

Actual:28/07/2015

Study start date

Planned:16/05/2016

Actual:20/06/2016

Data analysis start date

Planned:02/01/2017

Actual:10/02/2017

Date of final study report

Planned:29/03/2017

Actual:08/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

NPO PETROVAXPHARM

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable