Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000109

EU PAS number

EUPAS1000000109

Study ID

1000000109

Official title and acronym

Real-World Comparative Effectiveness Study of TYVASO (Inhaled Treprostinil) in the Treatment of PH-ILD

DARWIN EU® study

No

Study countries

Germany
Spain
United Kingdom
United States

Study description

This is an external comparator arm study using data from the INCREASE randomised controlled trial (RCT) and its open-label extension (treatment group) and COMPERA, REHAR, and UK Royal Brompton registries (external comparator) to generate evidence on the long-term comparative effectiveness of inhaled treprostinil versus standard of care in Europe.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Fabian Hoti

Primary lead investigator
ORCID number:
0000-0002-7464-3549
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Ferrer Internacional
Study protocol
Initial protocol

Ferrer_PH-ILD_TYVASO_Protocol_V1.0_Signed_19JAN2024.pdf

English (1.05 MB - PDF)View document
Updated protocol

Ferrer_PH-ILD_TYVASO_ECA_protocol_v2.0_09072024_signed.pdf

English (2.06 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable