Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease

Ferrer

Status

Conditions: Combined Pulmonary Fibrosis and Emphysema; Pulmonary Hypertension; Interstitial Lung Disease

Treatments: Drug: Inhaled Treprostinil

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05572996

FITREP-EAP2201

Details and patient eligibility

About

This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient consent

2. Males and females aged 18 years old or older

3. PH-ILD diagnosis:

   • Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC):

     • mPAP > 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and

   • Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE)

Exclusion criteria

1. Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
2. Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
3. Use of any concomitant investigational drug