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NCT05572996 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05572996
Other study ID # FITREP-EAP2201
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date October 2022
Source Ferrer Internacional S.A.
Contact Ferrer Medical Information
Phone +34 629 966 806
Email medinfo@ferrer.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled Treprostinil

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ferrer Internacional S.A.
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