Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Peyronie’s disease - a non-interventional post-authorization safety study (Sobi.Xiapex-PASS01)

Study identification

• EU PAS number:
  EUPAS9339
• Study ID:
  32787
• Official title and acronym:
  Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Peyronie’s disease - a non-interventional post-authorization safety study (Sobi.Xiapex-PASS01)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Denmark

  Finland

  Norway

  Sweden

  United Kingdom
• Study description:
  This is a non-interventional post-authorization safety study evaluating the effectiveness of the implemented additional risk minimization measure, i.e., the Xiapex educational material for healthcare professionals for treatment of Peyronie’s disease. The effectiveness will be assessed through a survey program which includes an Implementation survey and a Follow-up survey.
• Study status:
  Finalised

Research institutions and networks

Institutions

Swedish Orphan Biovitrum AB

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/01/2015

Actual:30/01/2015

Study start date

Planned:01/09/2016

Actual:24/04/2015

Data analysis start date

Planned:01/05/2017

Actual:05/03/2018

Date of final study report

Planned:31/12/2018

Actual:21/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Swedish orphan Biovitrum AB

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)