Survey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104951
• EU PAS number:
  EUPAS104950
• Study ID:
  104951
• Official title and acronym:
  Survey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Hungary

  Italy

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  The main objective of this survey is to assess whether sufficient levels of knowledge of posology and biological monitoring recommendations as described in the Exjade EU Summary of Product Characteristics (SmPC) can be attained among prescribers of Exjade/deferasirox, through the provision of Exjade EMs (which includes a Physician’s reference checklist) developed by Novartis.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 23/08/2022

Actual: 23/08/2022

Study start date

Planned: 31/01/2024

Actual: 12/01/2024

Data analysis start date

Planned: 15/02/2024

Actual: 15/02/2024

Date of final study report

Planned: 20/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis AG

Study protocol

Initial protocol

CICL670A2429 protocol V01 clean_Redacted

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)

Other study registration identification numbers and links

CICL670A2429