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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified December 2024 by Liquidia Technologies, Inc.
Sponsor
Liquidia Technologies, Inc.
Information Provided by (Responsible Party)
Liquidia Technologies, Inc.
Clinicaltrials.gov Identifier
NCT03992755
Other Study ID Numbers:
LTI-302
First Submitted
June 4, 2019
First Posted
June 19, 2019
Last Update Posted
January 28, 2025
Last Verified
December 2024

ClinicalTrials.gov processed this data on January 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

One of the greatest impediments to patient treatment satisfaction with current inhaled treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning. The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs could represent a major improvement in convenience and patient satisfaction, thereby improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINT® Technology (Particle Replication in Nonwetting Templates), as an alternative to current inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).

Condition or DiseaseIntervention/Treatment
Primary Pulmonary Hypertension
Drug: LIQ861 Inhaled Treprostinil

Study Design

Study TypeInterventional
Actual Enrollment92 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients
Study Start DateJuly 17, 2019
Actual Primary Completion DateMay 30, 2025
Actual Study Completion DateMay 30, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
LIQ861 Inhaled Treprostinil
LIQ861 inhaled treprostinil at capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg. LIQ861 will be administered using the RS00 Model 8 dry powder inhalation (DPI) device (Plastiape S.p.A.; Osnago, Italy) at dose levels of 25 μg capsule strength to 200 μg capsule strength treprostinil four times a day (QID) in individual patients. Titrating to dose levels beyond 200 μg capsule strength QID, under clinical investigator supervision, requires review and approval from the Medical Monitor.
Drug: 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.

Outcome Measures

Primary Outcome Measures
  1. Number of participants with treatment emergent adverse events (AEs).
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsLiquidia Technologies, Inc.
Locations
Banner University Medical Center | Phoenix Arizona, United States, 85006Arizona Pulmonary Specialists, Ltd. | Phoenix Arizona, United States, 85012West Los Angeles VA Healthcare Center | Los Angeles California, United States, 90073UC Davis Medical Center | Sacramento California, United States, 95817Los Angeles Biomedical Research Center | Torrance California, United States, 90502University of Colorado Anschutz Medical Campus | Aurora Colorado, United States, 80045University of Florida | Gainesville Florida, United States, 32610Mayo Clinic-Jacksonville | Jacksonville Florida, United States, 32224AdventHealth | Orlando Florida, United States, 32803Emory University School of Medicine | Atlanta Georgia, United States, 30322Northwestern Medicine, Feinberg School of Medicine | Chicago Illinois, United States, 60611University of Chicago Medicine | Chicago Illinois, United States, 60637University of Kansas Medical Center | Kansas City Kansas, United States, 66103Ochsner Medical Center | New Orleans Louisiana, United States, 70121Tufts Medical Center | Boston Massachusetts, United States, 02111Mayo Clinic-Rochester | Rochester Minnesota, United States, 55905University of New Mexico Health Science Center | Albuquerque New Mexico, United States, 87106University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45267Oregon Health and Science Center | Portland Oregon, United States, 97239Alleghany General Hospital | Pittsburgh Pennsylvania, United States, 15212UPMC Presbyterian Hospital | Pittsburgh Pennsylvania, United States, 15213UT Southwestern Medical Center | Dallas Texas, United States, 75390Houston Methodist Lung Center | Houston Texas, United States, 77030University of Texas Health Science Center at San Antonio | San Antonio Texas, United States, 78229INOVA Fairfax Medical Campus | Falls Church Virginia, United States, 22042
Investigators
Principal Investigator: Nicholas S Hill, MD, Tufts Medical Center