Active, not recruiting
Phase 2/3
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Condition(s) studied
Pulmonary Arterial Hypertension
Investigational drug(s) / intervention(s)
Treprostinil PalmitilPlacebo
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
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.