LIQ861 Inhaled Treprostinil: LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil.
Study summary
The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled.
5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861.
Exclusion Criteria:
1. Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study.
2. Patient withdrew consent during participation in another LIQ861 study.
3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous \[IV\] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study.
5. Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
Primary outcome measure(s)
Number of participants with treatment emergent adverse events (AEs). — Baseline until the end of study, approximately 2.5 years (Dec-2021). Treatment-emergent adverse events and serious adverse events will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.
Trial sites (25)
Facility
City
Region
Status
Banner University Medical Center
Phoenix
Arizona
Arizona Pulmonary Specialists, Ltd.
Phoenix
Arizona
West Los Angeles VA Healthcare Center
Los Angeles
California
UC Davis Medical Center
Sacramento
California
Los Angeles Biomedical Research Center
Torrance
California
University of Colorado Anschutz Medical Campus
Aurora
Colorado
University of Florida
Gainesville
Florida
Mayo Clinic-Jacksonville
Jacksonville
Florida
AdventHealth
Orlando
Florida
Emory University School of Medicine
Atlanta
Georgia
Northwestern Medicine, Feinberg School of Medicine
Chicago
Illinois
University of Chicago Medicine
Chicago
Illinois
University of Kansas Medical Center
Kansas City
Kansas
Ochsner Medical Center
New Orleans
Louisiana
Tufts Medical Center
Boston
Massachusetts
Mayo Clinic-Rochester
Rochester
Minnesota
University of New Mexico Health Science Center
Albuquerque
New Mexico
University of Cincinnati Medical Center
Cincinnati
Ohio
Oregon Health and Science Center
Portland
Oregon
Alleghany General Hospital
Pittsburgh
Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh
Pennsylvania
UT Southwestern Medical Center
Dallas
Texas
Houston Methodist Lung Center
Houston
Texas
University of Texas Health Science Center at San Antonio
San Antonio
Texas
INOVA Fairfax Medical Campus
Falls Church
Virginia
More Liquidia Technologies, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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