241501: Prospective and retrospective, non-interventional study to evaluate the safety and effectiveness of Obizur in real-life practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48205
• EU PAS number:
  EUPAS16055
• Study ID:
  48205
• Official title and acronym:
  241501: Prospective and retrospective, non-interventional study to evaluate the safety and effectiveness of Obizur in real-life practice
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Netherlands

  Poland

  United States
• Study description:
  The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 36 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 21/03/2016

Actual: 21/03/2016

Study start date

Planned: 03/01/2017

Actual: 14/12/2016

Data analysis start date

Planned: 02/07/2021

Actual: 30/07/2021

Date of final study report

Planned: 01/06/2022

Actual: 01/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Shire

Study protocol

Initial protocol

241501-protocol-original-redact

Updated protocol

241501-protocol-amend-3-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)