Study identification

EU PAS number

EUPAS1000000708

Study ID

1000000708

Official title and acronym

DARWIN EU® - Drug utilisation study in individuals with cystic fibrosis in Europe

DARWIN EU® study

Yes

Study countries

France
Germany
Italy
Norway
Spain
United Kingdom

Study description

Cystic fibrosis (CF) is a rare, life-limiting genetic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, resulting in multi-organ dysfunction primarily affecting the respiratory and gastrointestinal systems. While symptomatic treatments remain essential, recent advances in CFTR modulators represent a shift toward targeted therapies addressing the underlying protein defect.
Emerging evidence highlights both clinical benefits and potential safety concerns, including psychiatric adverse effects.
This study aims to generate real-world evidence on treatment utilisation and safety outcomes among individuals with a CF diagnosis across Europe.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ellen Gerritsen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable