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

Pulmonary Hypertension Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

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

Additional cohorts from either Group 1 or Group 3 may be defined in future protocol amendments.

Scheduled study visits to the clinic will occur at Screening, Baseline, Week 8, Week 16, Week 24, and Week 52. During this time, dose titration may be ordered at the Investigator's discretion and in accordance with the guidance provided.

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).

The exploratory objectives of the study are to assess the effects of LIQ861 on exercise capacity, functional class, relevant biomarkers, and imaging assessments. ;

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Hypertension

• NCT number: NCT06129240
• Study type: Observational [Patient Registry]
• Source: Liquidia Technologies, Inc.
• Status: Recruiting
• Start date: December 28, 2023
• Completion date: October 31, 2026