Effectiveness of inhaled treprostinil versus standard of care for the treatment of pulmonary hypertension associated with interstitial lung disease: A propensity score-weighted study of the INCREASE trial and registry data from Europe

05/07/2024
10/09/2024
EU PAS number:
EUPAS1000000238
Study
Planned
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Study identification

EU PAS number

EUPAS1000000238

Study ID

1000000238

Official title and acronym

Effectiveness of inhaled treprostinil versus standard of care for the treatment of pulmonary hypertension associated with interstitial lung disease: A propensity score-weighted study of the INCREASE trial and registry data from Europe

DARWIN EU® study

No

Study countries

Austria
Belgium
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Netherlands
Slovakia
Switzerland
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, and UK Royal Brompton registries (external comparator) to generate evidence on the long-term comparative effectiveness of inhaled treprostinil versus standard of care in adult patients with PH-ILD in Europe.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Fabian Hoti 0000-0002-7464-3549

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

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

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
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable