A POST AUTHORIZATION SAFETY SURVEILLANCE REGISTRY IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEMOPHILIA A IN USUAL CARE SETTINGS

Study identification

• EU PAS number:
  EUPAS5235
• Study ID:
  6917
• Official title and acronym:
  A POST AUTHORIZATION SAFETY SURVEILLANCE REGISTRY IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEMOPHILIA A IN USUAL CARE SETTINGS
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Bulgaria

  Croatia

  France

  Germany

  Greece

  Italy

  Morocco

  Netherlands

  Portugal

  Romania

  Serbia

  Spain

  Türkiye

  United Kingdom
• Study description:
  The study will evaluate the safety of ReFacto AF in the usual care setting in previously untreated patients with severe hemophilia A. Primary objective is to evaluate clinically significant FVIII inhibitor development in two groups of subjects. Secondary objective is overall safety of ReFacto AF in this Registry population.This Registry will be conducted to observe subjects using ReFacto AF at hemophilia treatment centers in Europe and other regions where ReFacto AF is commercially available.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 14/10/2013

Actual: 14/10/2013

Study start date

Planned: 15/07/2014

Date of final study report

Planned: 27/01/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes