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

NCT05572996 | Unknown

• 1 other identifier: FITREP-EAP2201
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/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.

Conditions

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

Keywords

Inhaled Treprostinil; Tyvaso; EAP; Expanded Access; Early Access; Compassionate Use; Named Patient Program; NPP; PH-ILD

Interventions

Inhaled Treprostinil DRUG

Also known as: Tyvaso

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferrer Internacional S.A.: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial; Emphysema

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ferrer Medical Information

CONTACT

+34 629 966 806; medinfo@ferrer.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10