Observational Study Evaluating Effectiveness and Safety of Real-World Treatment with Damoctocog alfa pegol in Previously Treated Patients with Hemophilia A (HEM-POWR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33625
• EU PAS number:
  EUPAS26416
• Study ID:
  33625
• Official title and acronym:
  Observational Study Evaluating Effectiveness and Safety of Real-World Treatment with Damoctocog alfa pegol in Previously Treated Patients with Hemophilia A (HEM-POWR)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Brazil

  Canada

  China

  Colombia

  Denmark

  Finland

  France

  Germany

  Greece

  Italy

  Japan

  Kuwait

  Luxembourg

  Mexico

  Netherlands

  Norway

  Russian Federation

  Saudi Arabia

  Slovenia

  Spain

  Sweden

  Switzerland

  Taiwan

  United Arab Emirates

  United States
• Study description:
  The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.
• Study status:
  Ongoing

Research institution and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Actual: 18/03/2019

Study start date

Planned: 15/11/2019

Actual: 21/10/2019

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BAYER AG

Study protocol

Initial protocol

20002_HEM-POWR_OS Protocol_v 1.1_2019-03-18_Redacted

Regulatory

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