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

Primary Pulmonary Hypertension Clinical Trial

Official title:

A 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992755
• Other study ID #: LTI-302
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 18, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2021
• Source: Liquidia Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Primary Pulmonary Hypertension

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Liquidia Technologies, Inc.	Nuventra, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).