- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05572996
Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease
October 5, 2022 updated by: Ferrer Internacional S.A.
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.
Study Overview
Status
Available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ferrer Medical Information
- Phone Number: +34 629 966 806
- Email: medinfo@ferrer.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 5, 2022
First Submitted That Met QC Criteria
October 5, 2022
First Posted (Actual)
October 10, 2022
Study Record Updates
Last Update Posted (Actual)
October 10, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FITREP-EAP2201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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