Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil

Phase 2

Terminated

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Inhaled dry powder treprostinil (LIQ861)

• Registration Number: NCT03884465
• Lead Sponsor: Liquidia Technologies, Inc.

Brief Summary

Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.

Detailed Description

Data will be collected on acute and chronic hemodynamic response to inhaled dry powder treprostinil (LIQ861) via right-heart catheterization. Study subjects will contribute to the overall safety profile of LIQ861.

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-21
• Study Start: 2019-11-11
• Primary Completion: 2020-12-23
• Study Completion: 2020-12-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Inhaled dry powder treprostinil (LIQ861)	Inhaled dry powder treprostinil (LIQ861)	Full study population receives inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg or 100μg capsule strengths.

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Vascular Resistance (PVR)	2 hours (120 minutes) post-dose on Day 1 and Week 16	Calculated in Wood units
Change in Pulmonary Artery Pressure (PAP)	2 hours (120 minutes) post-dose on Day 1 and Week 16	Systolic, diastolic, and mean pressure measured in millimeters of mercury (mmHG)
Change in Cardiac Output (CO)	2 hours (120 minutes) post-dose on Day 1 and Week 16	Measured in liters per minute (L/min)
Change in Pulmonary Artery Oxygen Saturation (PAO2%)	2 hours (120 minutes) post-dose on Day 1 and Week 16	Measured as a percent oxyhemoglobin saturation

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (AEs)	Baseline until the end of study, approximately 18 months (Mar-2021)	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.

Trial Locations

Locations (3)

CHRU de Nancy; 🇫🇷 Nancy, Vandoeuvre Les Nancy, France

CHU de Bicetre; 🇫🇷 Le Kremlin-Bicêtre, France

Studienambulanz fur Pulmonale Hypertonie at Medizinishe Klinik II, Universitatskinikum Giessen und Marburg GmbH; 🇩🇪 Gießen, Germany