Back to resultsInhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
Primary Purpose
Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Inhaled Treprostinil
Sponsored by
About this trial
This is an expanded access trial for Pulmonary Hypertension focused on measuring Inhaled Treprostinil, Tyvaso, EAP, Expanded Access, Early Access, Compassionate Use, Named Patient Program, NPP, PH-ILD
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT05572996
First Posted
October 5, 2022
Last Updated
October 5, 2022
Sponsor
Ferrer Internacional S.A.
1. Study Identification
Unique Protocol Identification Number
NCT05572996
Brief Title
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferrer Internacional S.A.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Inhaled Treprostinil
Other Intervention Name(s)
Tyvaso
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferrer Medical Information
Phone
+34 629 966 806
Email
medinfo@ferrer.com
12. IPD Sharing Statement
Learn more about this trial
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
We'll reach out to this number within 24 hrs