A Multinational Phase IV Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis (TAURUS)

Study identification

• EU PAS number:
  EUPAS15459
• Study ID:
  44492
• Official title and acronym:
  A Multinational Phase IV Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis (TAURUS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Canada

  Colombia

  France

  Germany

  Greece

  Italy

  Luxembourg

  Netherlands

  Slovenia

  Spain

  Taiwan

  United States
• Study description:
  The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice. In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/03/2016

Actual: 04/03/2016

Study start date

Planned: 01/09/2016

Actual: 14/10/2016

Date of final study report

Planned: 30/12/2022

Actual: 31/08/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer

Regulatory

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