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

Running, not enrolling · Phase 3

Conditions studied: Primary Pulmonary Hypertension

In brief

The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).

Key facts

Study ID

NCT03992755

Run by

Liquidia Technologies, Inc.

People needed

92

Starts

2019-07-18

Expected to finish

2025-05-31

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861.
• 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.
• 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.

You may not qualify if…

• 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.
• Patient withdrew consent during participation in another LIQ861 study.
• Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit).
• 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.
• 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.

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Los Angeles Biomedical Research Center — Torrance, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• AdventHealth — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern Medicine, Feinberg School of Medicine — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• University of New Mexico Health Science Center — Albuquerque, New Mexico, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Oregon Health and Science Center — Portland, Oregon, United States
• Alleghany General Hospital — Pittsburgh, Pennsylvania, United States
• UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Houston Methodist Lung Center — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• INOVA Fairfax Medical Campus — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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