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Active, not recruitingNCT03992755Updated Jan 29, 2025

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

A Phase 3 interventional study of LIQ861 Inhaled Treprostinil in Primary Pulmonary Hypertension, sponsored by Liquidia Technologies, Inc.. Active, not recruiting at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Liquidia Technologies, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
92
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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).

02

Conditions studied

  • Primary Pulmonary Hypertension

Keywords

  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Arterial Hypertension
  • Heritable Pulmonary Arterial Hypertension
  • Drug Induced Pulmonary Arterial Hypertension
  • Toxin Induced Pulmonary Arterial Hypertension
  • Connective tissue disease
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's enrollment of 92 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Liquidia Technologies, Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Evidence of a personally signed and dated 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 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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    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.

    Drug: LIQ861 Inhaled Treprostinil

Interventions

  • DrugLIQ861 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.

    Also known as: Inhaled treprostinil, Inhaled prostacyclin

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline until the end of study, approximately 2.5 years (Dec-2021).

07

Study locations

25 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2019 (actual). Primary completion is estimated for May 2025, 70 months after the start.

Of 43 industry-sponsored phase 3 interventional studies under Pulmonary Arterial Hypertension, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 83. This study's planned 70 months is above that.

Counting every sponsor, half of 49 studies reached it within 50 months; a quarter within 31 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2019
First posted
Jun 20, 2019
StartActual
Jul 18, 2019
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2025
Last update
Jan 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03992755
Lead sponsor
Liquidia Technologies, Inc.
Collaborators
Nuventra, Inc.
Responsible party
Sponsor
First posted
Jun 20, 2019
Start date
Jul 18, 2019
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Jan 29, 2025

Study contacts

Nicholas S Hill, MD
principal investigator · Tufts Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Treprostinil

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Liquidia Technologies, Inc.

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