Tecartus Survey: Quantitative Testing of Health Care Professional Knowledge About Tecartus® Risk Minimisation Measures

Study identification

• EU PAS number:
  EUPAS104052
• Study ID:
  105577
• Official title and acronym:
  Tecartus Survey: Quantitative Testing of Health Care Professional Knowledge About Tecartus® Risk Minimisation Measures
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France

  Germany

  Italy

  Portugal

  Sweden

  United Kingdom
• Study description:
  KT-EU-472-5966: The study was a non-interventional, cross-sectional survey of health care professionals (HCPs) based in Europe. The survey was conducted ≥ 12 months after Tecartus® had marketed approval in Europe. The survey was distributed to HCPs who have received training on additional risk minimisation measures (RMMs) and prescribe, handle, dispense, or administer Tecartus or manage patients experiencing Tecartus-related adverse events (AEs). The primary objective of the study was to measure the HCPs awareness and knowledge of RMMs for Tecartus.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Kite

Study timelines

Date when funding contract was signed

Actual: 29/03/2021

Study start date

Planned: 21/04/2023

Actual: 09/06/2023

Date of final study report

Planned: 21/03/2024

Actual: 19/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kite, A Gilead Company

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)