DARWIN EU® - Characteristics of individuals with acute graft vs. host disease with intestinal involvement

17/12/2025
11/03/2026
EU PAS number:
EUPAS1000000878
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000878

Study ID

1000000878

Official title and acronym

DARWIN EU® - Characteristics of individuals with acute graft vs. host disease with intestinal involvement

DARWIN EU® study

Yes

Study countries

France
Germany
Spain

Study description

Acute graft-versus-host disease (aGvHD) is a serious and potentially life-threatening complication that can
occur after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Intestinal involvement in aGvHD is particularly severe and is associated with poor prognosis. This form of
aGvHD is often resistant to first-line corticosteroid therapy, and failure of second-line treatments like
ruxolitinib further complicates management and has a poor prognosis.
Given the high mortality associated with advanced gastrointestinal (GI) aGvHD, especially after failure of
standard treatments, there is a need to generate data on use of treatment for aGvHD with intestinal
involvement in real life.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Katia Verhamme

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