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

NCT ID: NCT05572996

Last Updated: 2022-10-10

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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

Interventions

Inhaled Treprostinil

Intervention Type: DRUG

Other Intervention Names

Tyvaso

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ferrer Medical Information

Role: CONTACT

medinfo@ferrer.com

+34 629 966 806

Other Identifiers

FITREP-EAP2201

Identifier Type: -

Identifier Source: org_study_id