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.
Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH. Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD) Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861. The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).
Study Type
OBSERVATIONAL
Enrollment
80
trepostinil inhalation powder in combination with inhaler
Arizona Pulmonary Specialists
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Time frame: Baseline until the end of the study.
Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)
Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Time frame: 16 weeks
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Phoenix, Arizona, United States
The Medical Research Group, Inc.
Fresno, California, United States
RECRUITINGUniversity of California San Diego
La Jolla, California, United States
WITHDRAWNUCLA Westwood
Los Angeles, California, United States
ACTIVE_NOT_RECRUITINGUC Davis
Sacremento, California, United States
ACTIVE_NOT_RECRUITINGUCSF
San Francisco, California, United States
ACTIVE_NOT_RECRUITINGNational Jewish Health
Denver, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
WITHDRAWNAdvent Health
Orlando, Florida, United States
RECRUITINGTampa General Hospital Center of Research Excellence
Tampa, Florida, United States
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