Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03992755 | Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil | PHASE3 | ACTIVE NOT_RECRUITING | 92 | — | — | Jul 18, 2019 | May 31, 2025 | Jan 29, 2025 | 25 | United States |
| NCT03399604 | Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil | PHASE3 | COMPLETED | 121 | — | — | Jan 2, 2018 | Nov 25, 2019 | Jul 30, 2024 | 38 | United States |
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.
There were two treatment arms analyzed for events in the study. All subjects that participated in the PK study were part of the transition group and not analyzed separately for adverse events. Treatment-Emergent Adverse Events and Serious Adverse Events will be grouped by MedDRA System Organ Class, dose level, time on drug, and relationship to dose titration
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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, ...