Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are Refractory to Previous Treatments

Study identification

• EU PAS number:
  EUPAS42043
• Study ID:
  45096
• Official title and acronym:
  Post-Authorization Long Term Safety Surveillance Study of Fostamatinib in Adult Patients with Chronic Immune Thrombocytopenia (cITP) who are Refractory to Previous Treatments
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This post-marketing observational study is a multi-centre, prospective, non-interventional, active surveillance study with intensive monitoring in adult patients with refractory cITP who are planned to start receiving new treatment with fostamatinib. This study is intended to provide additional long-term safety data of fostamatinib in patients with cITP according to the current prescribing information of the European label in a real-world setting.
• Study status:
  Planned

Research institutions and networks

Institutions

Instituto Grifols

Study timelines

Date when funding contract was signed

Actual: 17/04/2020

Study start date

Planned: 28/02/2022

Date of final study report

Planned: 01/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Grifols Bioscience Industrial Group

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable