Treprostinil Palmitil: Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler.
Placebo: Administered by oral inhalation using a Plastiape capsule-based dry powder inhaler
Study summary
The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of studies INS1009-201, INS1009-202 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.
* Any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia.
* New-onset of heart disease including left ventricular ejection fraction (LVEF) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc).
* New evidence of thromboembolic disease as assessed by ventilation/perfusion (VQ) scan, pulmonary angiography, or pulmonary computed tomography (CT) scan.
* Active and current symptomatic coronavirus disease 2019 (COVID-19) or previous severe disease and/or hospitalization due to COVID-19.
* Interval organ transplantation.
* New active liver disease or hepatic dysfunction.
* Interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
* Use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including TPIP of the lead-in study.
* Current use of cigarettes (as defined by Centers for Disease Control and Prevention \[CDC\]) or e-cigarettes: An adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days.
* Participants who currently inhale marijuana (recreational or medical).
Note: Other inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Number of Participants Who Experience at Least one Treatment Emergent Adverse Event (TEAE) and TEAEs by Severity — From screening up to last follow up visit (Up to approximately 26 months)
Trial sites (45)
Facility
City
Region
Status
USA005
Jacksonville
Florida
USA011
Tampa
Florida
USA006
Chicago
Illinois
USA001
Chicago
Illinois
USA102
New York
New York
USA016
Dallas
Texas
ARG009
Quilmes
Buenos Aires
ARG006
Rosario
Santa Fe Province
ARG007
San Miguel de Tucumán
Tucumán Province
ARG004
Córdoba
Argentina
ARG001
Córdoba
Argentina
AUT002
Linz
Upper Austria
AUT001
Vienna
Austria
BEL003
Brussels
Belgium
BRA004
Belo Horizonte
Minas Gerais
BRA006
Porto Alegre
Rio Grande do Sul
BRA002
Blumenau
Santa Catarina
DNK001
Aarhus
Central Jutland
GER005
Heidelberg
Baden-Wurttemberg
GER003
München
Bavaria
GER002
Lübeck
Schleswig-Holstein
ITA002
Pavia
Lombardy
ITA005
Monza
Italy
ITA001
Palermo
Italy
ITA004
Roma
Italy
JPN005
Sapporo
Hokkaido
JPN004
Sapporo
Hokkaido
JPN007
Kurume-shi
Hukuoka
JPN006
Tsukuba
Ibaraki
JPN002
Okayama
Okayama-ken
JPN003
Suita-Shi
Osaka
MYS005
Alor Star
Kedah
MYS002
Kuantan
Pahang
MYS004
Sungai Buloh
Selangor
MEX005
Lomas de Guevara
Jalisco
MEX001
Monterrey
Nuevo León
MEX003
Mexico City
Mexico
MEX004
San Luis Potosí City
Mexico
PHL001
Quezon City
National Capital Region
PHL002
Makati City
Philippines
+ 5 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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