DARWIN EU® - Assessment of immunoglobulin use in clinical practice

10/11/2025
23/01/2026
EU PAS number:
EUPAS1000000823
Study
Planned
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Study identification

EU PAS number

EUPAS1000000823

Study ID

1000000823

Official title and acronym

DARWIN EU® - Assessment of immunoglobulin use in clinical practice

DARWIN EU® study

Yes

Study countries

Denmark
France
Germany
United Kingdom

Study description

Immunoglobulins can be routinely administered as replacement therapy in immunodeficient patients or are
used as immunomodulating doses to treat various immune-related and inflammatory diseases. The global
demand of immunoglobulins increases every year, resulting in intermittent shortages that could affect
individuals with conditions that have limited alternative treatments. Prolonged low levels of certain
immunoglobulins can increase the risk of certain infections and replenishment of these immunoglobulins
can reduce this risk. This study aims to generate real-world evidence on the treatment and characteristics
of individuals receiving immunoglobulins.

Study status

Planned
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:

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