An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Liquidia Technologies, Inc.
- Study ID
- NCT06129240
- Status
- Recruiting
Conditions
- Interstitial Lung Disease
- Pulmonary Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- LIQ861 — DRUGtrepostinil inhalation powder in combination with inhaler
Study Details
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.
Key Dates
- Start date
- Dec 28, 2023
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2027
- Completion
- Feb 8, 2028
Study Design
- Enrollment
- 80 participants (estimated)
Arms
- Arm: Cohort APH-ILD
- Arm: Cohort BPH-ILD
Primary Outcome Measure
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) [ Time Frame: Baseline until the end of the study. ]
Locations (23)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Pulmonary Specialists | Phoenix | Arizona | 85012 | |
| The Medical Research Group, Inc. | Fresno | California | 93720 | |
| University of California San Diego | La Jolla | California | 92093 | - |
| UCLA Westwood | Los Angeles | California | 90095 | - |
| UC Davis | Sacremento | California | 95817 | - |
| UCSF | San Francisco | California | 94143 | - |
| National Jewish Health | Denver | Colorado | 80206 | |
| Hartford Hospital | Hartford | Connecticut | 06102 | - |
| Advent Health | Orlando | Florida | 32803 | |
| Tampa General Hospital Center of Research Excellence | Tampa | Florida | 33606 | |
| Vincent Medical Group | Indianapolis | Indiana | 46260 | |
| Norton Pulmonary Specialists | Louisville | Kentucky | 40241 | - |
| Tufts Medical Center | Boston | Massachusetts | 02111 | - |
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
| University of Minnesota | Minneapolis | Minnesota | 55455 | - |
| NYU Langone Medical Center | New York | New York | 10016 | - |
| University of Rochester | Rochester | New York | 14627 | - |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | - |
| University of Cincinnati Health | Cincinnati | Ohio | 45219 | - |
| Summit Health | Bend | Oregon | 97701 | |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | |
| Houston Methodist | Houston | Texas | 77030 | - |
| University of Utah | Salt Lake City | Utah | 84112 | - |
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