Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104769
• EU PAS number:
  EUPAS104768
• Study ID:
  104769
• Official title and acronym:
  Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Poland

  Spain

  United Kingdom
• Study description:
  This study will be a cross-sectional survey of knowledge of the risks and safe use of venetoclax as outlined in the patient card among adult patients who have recently received venetoclax for treatment of CLL per standard of care. Patients will be identified through a diverse selection of medical practices representing haematologists who prescribe venetoclax across at least 5 European countries. Patients will be invited to participate by their physician and will be asked to complete a one-time self-administered structured questionnaire.
• Study status:
  Ongoing

Research institution 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: 17/11/2021

Study start date

Actual: 24/04/2024

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Study protocol

Initial protocol

P22-905-protocol-abstract_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

P22-905