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Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects

NCT03884465•Liquidia Technologies, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. An Institutional Review Board (IRB) approved informed consent is signed and dated by the subject prior to any study related activities.
•2. The subject is 18 years of age or older.
•3. If the subject is a female of childbearing potential, then the subject has a negative pregnancy test at the Day 1 Visit (tests performed within 2 days before Day 1 are accepted) and agrees to practice a highly effective (failure rate of less than 1% per year when used consistently and correctly) method of birth control until 24 hours after completion of all study assessments defined in Appendix 1. If the subject is postmenopausal or has documented surgical sterilization, a pregnancy test and birth control is not necessary. It is the Investigator's responsibility for determining whether the subject has adequate birth control for study participation.
•4. The subject has been diagnosed with PAH belonging to one of the following subgroups of the updated Nice Clinical Classification Group 1, which includes:
•1. Idiopathic PAH (1.1), or
•2. Heritable PAH (1.2), or
•3. Drug and toxin induced PAH (1.3), or
•4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
•5. The subject is NYHA Functional Class II - IV at Screening and:
•1. has not previously been treated for PAH, or
+31 more criteria

Exclusion Criteria

•1. The subject's clinical condition is such that, in the opinion of the Investigator, they are not expected to remain clinically stable for the duration of the study.

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

Key Dates

Start Date

November 11, 2019

Primary Completion Date

December 23, 2020

Completion Date

December 23, 2020

Last Updated

September 13, 2021

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Inhaled dry powder treprostinil (LIQ861)

DRUG

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization