Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104738
• EU PAS number:
  EUPAS104737
• Study ID:
  104738
• Official title and acronym:
  Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Poland

  Spain

  United Kingdom
• Study description:
  This study will be a cross-sectional survey to evaluate the receipt and use of the Direct Healthcare Professional Communication (DHPC), including knowledge among participating haematologists regarding Tumour Lysis Syndrome (TLS) assessment and adherence to the TLS risk-minimisation measures following availability of the venetoclax revised Summary of Product Characteristics (SmPC) and dissemination of DHPC in Europe. Haematologists from at least 5 European countries will be recruited and asked to complete a one-time self-administered structured questionnaire.
• Study status:
  Ongoing

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Actual: 07/08/2021

Study start date

Actual: 01/11/2023

Date of final study report

Planned: 31/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

P22907-protocol-abstract_redacted

Updated protocol

P22-907_Protocol_v1.1_Redacted.pdf

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

P22-907