A Post-Authorisation Safety Study to Evaluate the Safety of Marstacimab Among Patients with Haemophilia A or B using Real-World Data in Haemophilia Registers

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000947
• Study ID:
  1000000947
• Official title and acronym:
  A Post-Authorisation Safety Study to Evaluate the Safety of Marstacimab Among Patients with Haemophilia A or B using Real-World Data in Haemophilia Registers
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  The study will address the research question: ; What are the incidence rates of TEs in patients with haemophilia A or B with or without inhibitors treated with marstacimab during routine clinical care in real-world settings in the UK and the US?; ; The primary study objective is:; - To describe the incidence rates of TEs among patients with haemophilia A or B with or without inhibitors in the patient cohort treated with marstacimab during routine clinical care.; ; The secondary study objectives are:; - To describe the incidence rates of TEs among patients with haemophilia A or B with or without inhibitors in the patient cohort unexposed to marstacimab and receiving routine prophylaxis.; - To describe clinical characteristics of patients with haemophilia A or B with or without inhibitors (those exposed to marstacimab and those unexposed to marstacimab and receiving routine prophylaxis) who experience a TE.; - To describe clinical characteristics of patients with haemophilia A or B with or without inhibitors (those exposed to marstacimab and those unexposed to marstacimab and receiving routine prophylaxis) who did not experience a TE.
• Study status:
  Planned

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Pfizer

Study timelines

Date when funding contract was signed

Planned:10/10/2023

Actual:10/10/2023

Study start date

Planned:27/02/2026

Date of interim report, if expected

Planned:01/02/2030

Date of final study report

Planned:01/02/2035

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

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)