Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil
NCT ID: NCT03992755
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
92 participants
INTERVENTIONAL
2019-07-18
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Nuventra, Inc.
INDUSTRY
Liquidia Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas S Hill, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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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
Countries
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Other Identifiers
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LTI-302
Identifier Type: -
Identifier Source: org_study_id
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