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

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 institution and networks

Institutions

Ferrer Internacional

Global Database Studies (GloDaSt), IQVIA

Czechia

Finland

Germany

Slovakia

Spain

Study timelines

Date when funding contract was signed

Planned: 09/03/2023

Actual: 09/03/2023

Study start date

Planned: 01/06/2023

Actual: 17/07/2023

Data analysis start date

Planned: 01/07/2024

Date of final study report

Planned: 31/01/2025

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

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

FITREP-NIS-2401