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| Name | Class |
|---|---|
| Nuventra, Inc. | INDUSTRY |
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The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas S Hill, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Arizona Pulmonary Specialists, Ltd. |
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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.
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| Phoenix |
| Arizona |
| 85012 |
| United States |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Los Angeles Biomedical Research Center | Torrance | California | 90502 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Mayo Clinic-Jacksonville | Jacksonville | Florida | 32224 | United States |
| AdventHealth | Orlando | Florida | 32803 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Northwestern Medicine, Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic-Rochester | Rochester | Minnesota | 55905 | United States |
| University of New Mexico Health Science Center | Albuquerque | New Mexico | 87106 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| Oregon Health and Science Center | Portland | Oregon | 97239 | United States |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Houston Methodist Lung Center | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| INOVA Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D065627 | Familial Primary Pulmonary Hypertension |
| D000081029 | Pulmonary Arterial Hypertension |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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