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

NCT03992755 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: LTI-302
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Primary Pulmonary Hypertension

Keywords

Pulmonary Arterial Hypertension; Idiopathic Pulmonary Arterial Hypertension; Heritable Pulmonary Arterial Hypertension; Drug Induced Pulmonary Arterial Hypertension; Toxin Induced Pulmonary Arterial Hypertension; Connective tissue disease

Outcome Measures

Primary Outcomes (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.

  Baseline until the end of study, approximately 2.5 years (Dec-2021).

Study Arms (1)

LIQ861 Inhaled Treprostinil

EXPERIMENTAL

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

Interventions

LIQ861 Inhaled Treprostinil DRUG

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.

Also known as: Inhaled treprostinil, Inhaled prostacyclin

LIQ861 Inhaled Treprostinil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Liquidia Technologies, Inc.: lead
• Nuventra, Inc.: collaborator

Study Sites (25)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012, United States

Location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Los Angeles Biomedical Research Center

Torrance, California, 90502, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32224, United States

Location

AdventHealth

Orlando, Florida, 32803, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87106, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Oregon Health and Science Center

Portland, Oregon, 97239, United States

Location

Alleghany General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Lung Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

INOVA Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Pulmonary Arterial Hypertension; Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicholas S Hill, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will evaluate the long-term safety of LIQ861 in PAH (WHO Group 1) patients who have completed a Liquidia LIQ861 clinical study. All patients will be treated on an outpatient basis until regulatory approval of LIQ861 or study is terminated by sponsor. Study enrollment will occur after final assessments from a prior study have been completed.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 20, 2019
• Study Start: July 18, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)