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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Expanded Access
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05572996
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ferrer Internacional S.A.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Available
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema