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Recruiting NCT06129240

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH

— Observational Pulmonary Hypertension Interstitial Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LIQ861.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Interstitial Lung Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension

Overview

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.

Detailed description

Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.

Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD)

Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861.

The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).

Interventions

  • Drug LIQ861
    trepostinil inhalation powder in combination with inhaler

Primary outcome measures

  • Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) [Time frame: Baseline until the end of the study.]
  • Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) [Time frame: 16 weeks]

Eligibility criteria

Cohort A Key Inclusion Criteria:

  • Males or Females between 18 years to 80 years of age.
  • Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following hemodynamic parameters.
  • i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg.

OR

  • An exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 21 mmHg.
  • 6-minute walk distance of ≥ 125 meters

Cohort A Key Exclusion Criteria:

A Subject is not eligible for inclusion in the study if any of the following criteria apply:

  • PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
  • History of hemodynamically significant left-sided heart disease.
  • Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.
  • Initiation of pulmonary rehabilitation.

Cohort B Key Inclusion Criteria

  • Male or Females between 18 years to 75 years of age at Screening.
  • Has a diagnosis of WHO Group 3 PH-ILD confirmed with CT chest imaging performed at the screening visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following documented parameters:
  • Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and
  • Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and
  • A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg
  • Subjects must be on protocol specified dose of inhaled treprostinil QID not at treatment goal, and able to transition from their prescribed dose of inhaled Treprostinil therapy to LIQ861.
  • 6-minute walk distance of ≥ 200 meters

Cohort B Key Exclusion Criteria

  • PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
  • Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®.
  • History of Bronchospasm with Tyvaso or Tyvaso DPI.
  • History of persistent moderate asthma or severe asthma.
  • History of hemodynamically significant left-sided heart disease.
  • Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 23 centers
  • Arizona Pulmonary Specialists — Phoenix
  • The Medical Research Group, Inc. — Fresno
  • University of California San Diego — La Jolla
  • UCLA Westwood — Los Angeles
  • UC Davis — Sacremento
  • UCSF — San Francisco
  • National Jewish Health — Denver
  • Hartford Hospital — Hartford
  • … and 15 more centers

Identifiers

NCT: NCT06129240 · LTI-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗