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Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso

An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso

NCT03950739•United Therapeutics

View on ClinicalTrials.gov

Summary

This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.

Detailed Description

United Therapeutics Corporation (UTC) developed a combination drug-device product comprised of a dry powder formulation of Treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler. In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily \[QID\]) were evaluated after switching to a corresponding dose of TreT. Patients underwent PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients were offered the opportunity to participate in the Optional Extension Phase until the drug/device became commercially available.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject voluntarily gave informed consent to participate in the study.
•2. Subject was aged 18 years or older at the time of signing informed consent.
•3. Women of childbearing potential were those who had experienced menarche and who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or were not postmenopausal (defined as amenorrhea for at least 12 consecutive months). WOCBP must have been nonpregnant (as confirmed by a urine pregnancy test at Screening prior to initiating study medication), nonlactating, and did 1 of the following:
•1. Abstained from intercourse (when it was in line with their preferred and usual lifestyle), or
•2. Used 2 medically acceptable, highly effective forms of contraception for the duration of study, and at least 30 days after discontinuing TreT. Medically acceptable, highly effective forms of contraception included approved hormonal contraceptives (oral, injectable, and implantable), intrauterine devices or systems, and barrier methods (such as a condom or diaphragm) when used with a spermicide.
•4. Males with a partner of childbearing potential must have used a condom for the duration of treatment and for at least 48 hours after discontinuing TreT.
•5. Subject was diagnosed with PAH as defined by the following World Health Organization (WHO) Group 1 categories:
•1. Idiopathic/familial
•2. Associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years prior to Screening)
•3. Associated with collagen vascular disease
+7 more criteria

Exclusion Criteria

•1. Subject was pregnant or lactating.
•2. Subject was diagnosed with pulmonary hypertension for reasons other than WHO Group 1 as outlined in Inclusion Criterion 5 (including but not limited to portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, hemolytic anemia, sarcoidosis).
•3. Subject had a history of uncontrolled sleep apnea, parenchymal lung disease, or hemodynamically significant left-sided heart disease (including but not limited to aortic or mitral valve disease, pericardial constriction, restrictive or congestive cardiomyopathy, or coronary artery disease).
•4. Subject was currently taking any other prostacyclin analogue or agonist, including but not limited to selexipag, epoprostenol, iloprost, or beraprost; except for acute vasoreactivity testing.
•5. Subject experienced an acute exacerbation of disease or hospitalization for any reason within 30 days of the Screening Visit or between Screening and Baseline.
•6. Subject was WHO Functional Class IV at Screening.
•7. Subject had used any investigational drug/device or participated in any other investigational study with therapeutic intent within 30 days prior to the Screening Visit.
•8. Subject had a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to treprostinil or excipients in the investigational product.
•9. Subject had conditions that, in the opinion of the Investigator, would make the subject ineligible.
•10. Subject was not able to perform inhalation maneuvers that met inspiratory training criteria.
+3 more criteria

Locations (16)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

Ascension / St. Vincent's Lung Institute

Jacksonville, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

University of South Florida Center for Advanced Lung Disease

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

University of Louisville Clinical Trials Unit

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Key Dates

Start Date

September 17, 2019

Primary Completion Date

August 22, 2023

Completion Date

August 22, 2023

Last Updated

November 1, 2024

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Treprostinil Inhalation Powder

DRUG

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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: November 1, 2024Data 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

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso

Inclusion Criteria

Exclusion Criteria

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

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

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