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

Planned
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Daniel Wolin

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AbbVie
Study protocol
Initial protocol

P22907-protocol-abstract_redacted

English (124.23 KB - PDF)View document
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)