Study identification

EU PAS number

EUPAS19654

Study ID

40919

Official title and acronym

Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Dupuytren’s contracture - a non-interventional post-authorization safety study

DARWIN EU® study

No

Study countries

Bulgaria
France
Romania
Slovenia

Study description

This study is to assess the effectiveness of the Xiapex educational material through a survey administered to physicians that have registering in the MAH’s Dupuytren’s Trained Physicians database and that are working in countries where Xiapex was launched after Dec -2016. Only those physicians who have been appropriately trained in the usage of Xiapex® in the treatment of Dupuytren’s contracture shall use Xiapex. The surveys will assess knowledge transfer of 5 domains (i.e., indication, injection procedure and posology, treatment cycles, extension, and the identified risks associated with Xiapex treatment). Overall, up to 20 physicians are expected to have received the survey within the distribution period of 01-Apr-2017 to 01-Apr-2020. The overall return rate is expected to be 80%. The primary endpoint will be summarized descriptively. Product withdrawn, study prematurely terminated.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 20 centres are involved in the study

Contact details

Maria Ilemosoglou

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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)