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

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

• Registration Number: NCT05572996
• Lead Sponsor: Ferrer Internacional S.A.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified