Treprostinil Palmitil Inhalation Powder in Pulmonary Arterial Hypertension

What is the Purpose of this Study?

The purpose of this study is to evaluate an experimental drug called treprostinil palmitil inhalation powder (TPIP) for the treatment of pulmonary arterial hypertension (PAH). The study aims to determine the safety, tolerability, and effectiveness of TPIP in PAH patients. Specifically, researchers want to know how safe it is to take TPIP for a long period of time, as well as learn more about how the drug works in the human body and the substances it produces (biomarkers). The study will also measure the amount of TPIP in the body (pharmacokinetics) and examine how the body reacts to the drug. Study procedures also include laboratory blood testing, a 6-minute walk test, and electrocardiogram (ECG).


Eligibility

  • Male and female participants who completed end of treatment study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study. Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
  • Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-201, INS1009-202, or any other lead-in PAH TPIP study.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

An Open-Label Extension Study to Assess the Safety, Tolerability, and Effectiveness of the Long-Term use of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension

Study Details
Disease Type/Condition

Pulmonary hypertension

Principal Investigator

Hage, Antoine

Age Group

Adult

Phase

II/III

IRB Number

STUDY00002413

ClinicalTrials.gov ID

NCT05649748

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Pulmonary hypertension

Principal Investigator

Hage, Antoine

Age Group

Adult

Phase

II/III

IRB Number

INS1009-203

ClinicalTrials.gov ID

NCT05649748

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org