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

Sponsor

Ferrer Internacional S.A. (Industry)

Overall Status

Available

CT.gov ID

NCT05572996

Collaborator

(none)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension Interstitial Lung Disease Combined Pulmonary Fibrosis and Emphysema	Drug: Inhaled Treprostinil

Study Design

Study Type:

Expanded Access

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient consent
Males and females aged 18 years old or older
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:

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