A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
Recruiting
Phase 3
Interventional Study
Pulmonary Hypertension Due to Lung Disease (Disorder)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 344 (estimated)
- Sponsor
- Liquidia Technologies, Inc. · Industry
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About This Trial
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it ta…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant is between 18 years to 80 years old.
* Has a confirmed diagnosis of ILD based on High Resolution Computed Tomography (HRCT) chest imaging.
* Evidence of PH as demonstrated from Right Heart Catheterization (RHC) with the following hemodynamic parameters:
* Pulmonary…
Contacts