2026-03-30
minor
2 amendments v7-v8
2 re-verifications since 2026-03-18, no change to tracked fields
2025-12-08
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2024-06-30→2025-03-20
Completion date2025-07-31→2031-03-31
Study sites5→8
Eligibility criteria-786 characters
Key Inclusion Criteria:
Able to understand and complete study requirements and provide written informed consent.
Males and females ≥18 and ≤80 years of age at the time of informed consent.
All sexually active male subjects and female subjects of childbearing potential must use an acceptable, highly effective method of contraception.
Diagnosed with
PAH belonging to at least 1 of the following [...] s with PAH: Documentation of having PAH as confirmed by RHC within 12 months prior to screening and meeting the following criteria:
i. Mean PAP >20 mmHg.
ii.
Pu [...] irmation of the underlying ILD must be based [...]
Secondary endpoints-165 characters
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
Pharmacokinetics assessed by steady-state PK parameters of treprostinil from Tyvaso and L606
Study description-571 characters
[...] y of repeated doses of L606 in patients with PAH or PH-ILD.
The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population.
The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance [6MWD] and Bor [...] Cohort A: Subjects with PAH or PH-ILD receiving prior stable doses of Tyvaso (4 times daily) and willing to switch to L606 (twice daily).
Cohort B: Subjects with PAH (not initially on prostacyclin [...] tor.
Cohort A subjects will sequentially par [...]
2024-10-08
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-08-31→confirmed 2024-06-30
Enrollment targetestimated 60→confirmed 28
Study sitesdetails revised at 5 of 5 sites
2023-08-09
minor
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v4
Lead sponsorPharmosa Biopharm Inc.→Liquidia Technologies, Inc.
2023-06-08
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2022-10-31→2024-08-31
Completion date2023-08-31→2025-07-31
Study sites1→5
Eligibility criteria+233 characters
[...] rovide written informed consent.
Males and females ≥18 and ≤7580 years of age at the time of informed consent.
All sexually [...] ive method of contraception.
Diagnosed with
PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of [...] ory Society Guidelines for the diagnosis and treatment of PH at least 1 year prior to screening.
or
PH-ILD Group 3 European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH.
Subjects with Group 3 PH that is not related to underlying ILD are not eligible.
Subjects [...] [...]
Secondary endpointsdetails revised at 1 of 2 entries
Primary endpoints1 to 3 entries
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)
Study description+272 characters
This single-arm, Phase 3, 2-part, open-label, multicenter study aims to demo [...] tolerability of repeated doses of L606 in patients with PAH switchingor from a stable Tyvaso dosePH-ILD.
The current Phase 3 study will help determine the short-te [...] quality of life (QoL), and treatment satisfaction with L606 in patients with PAH.
PartSubjects 1who meet all the inclusion criteria and none of the studyexclusion iscriteria short-termwill (2-week)be evaluationenrolled ofto L606 in patients with PAH.
Part 2one of the study2 willcohorts:
Cohort continueA: to assess the long-term safety and efficacy of L606 in [...] [...]
Study title+10 characters
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
Show 2 earlier versions
2022-01-26
minor
Study Status, Eligibility v2
Eligibility criteria+50 characters
[...] d stable doses
Can complete a screening 6MWD of ≥150 meters
Evidence of forcedForced expiratory volume in 1 second (FEV1) >65% of predicted and FEV1/forced vital capacity (FVC) ratio >65% duringat the 6-month period prior to enrollmentscreening.
Key Exclusion Criteria:
Pregnant or lactating female at sc [...] or baseline.
Left ventricular ejection fraction of ≤45% on anya historical echocardiogram within 6 months of screening.
Patients who recovered their LVEF culd be allowed, as judged by investigator.
History of uncontrolled sleep apnea, parenchymal lung disease, or hemodynamically significant lef [...] [...]
2021-11-10
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study title-29 characters
A Phase 3 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and EfficacyTolerability of L606 in Subjects With PAH
2020-12-27
minor
Original filing