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Clinical Trials in the USA / NCT03992755
Active, not recruiting Phase 3

Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil

NCT03992755 · tracked via the Priya Life Science USA tracker
Sponsor
Liquidia Technologies, Inc.
Phase
Phase 3
Started
2019-07-18
Last updated
2025-01-29

Condition(s) studied

Primary Pulmonary Hypertension

Investigational drug(s) / intervention(s)

LIQ861 Inhaled Treprostinil

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)

Trial sites (25)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT03992755 on ClinicalTrials.gov ↗ ← All trials in the USA