An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Launched by INSMED INCORPORATED · Dec 6, 2022
Trial Information
Current as of January 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the long-term safety and tolerability of a medication called Treprostinil Palmitil Inhalation Powder (TPIP) for people with a condition known as Pulmonary Arterial Hypertension (PAH). PAH affects the blood vessels in the lungs, making it harder for blood to flow and causing symptoms like shortness of breath. The trial is open to men and women aged 65 to 74 who have previously completed other studies with TPIP. To join, participants must meet specific health criteria, such as not having started certain other treatments or having significant heart or lung issues since their last study.
If you or a loved one are eligible and decide to participate, you will be closely monitored while using TPIP over an extended period. This helps researchers understand how well the medication works and its effects on your health. It's important to know that there are some health requirements to ensure safety, including not having current serious health conditions like active heart disease or recent COVID-19. Overall, this study aims to provide more information about TPIP, which could help improve treatment options for PAH in the future.
Gender
ALL
Eligibility criteria
- 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.
About Insmed Incorporated
Insmed Incorporated is a biopharmaceutical company focused on developing innovative therapies for patients with serious and rare diseases, particularly those associated with pulmonary and infectious conditions. Committed to advancing science and improving patient outcomes, Insmed leverages its expertise in drug development and commercialization to bring new treatments to market. The company emphasizes a patient-centric approach, engaging with the medical community and stakeholders to address unmet medical needs and enhance the quality of life for individuals affected by complex health challenges. Through rigorous clinical trials and a strong pipeline of products, Insmed strives to lead the way in transforming the landscape of rare disease treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wien, , Austria
Belgrade, , Serbia
Belgrade, , Serbia
Quilmes, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Pavia, Lombardia, Italy
Kurume Shi, Hukuoka, Japan
Kuantan, Pahang, Malaysia
Sungai Buloh, Selangor, Malaysia
Quezon City, National Capital Region, Philippines
Makati City, , Philippines
Sevilla, , Spain
Heidelberg, Baden Württemberg, Germany
Palermo, Sicilia, Italy
Jacksonville, Florida, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Bath, Avon, United Kingdom
Passo Fundo, Rio Grande Do Sul, Brazil
Lübeck, Schleswig Holstein, Germany
Roma, , Italy
Okayama Shi, Okayama, Japan
Suita Shi, Osaka, Japan
Monza, , Italy
Chicago, Illinois, United States
Linz, Oberösterreich, Austria
Dallas, Texas, United States
San Miguel De Tucuman, Tucuman, Argentina
San Luis Potosi, , Mexico
New York, New York, United States
Sapporo Shi, Hokkaido, Japan
Chicago, Illinois, United States
Belo Horizonte, Minas Gerais, Brazil
Alor Setar, Kedah, Malaysia
Monterrey, Nuevo León, Mexico
Santander, , Spain
Aarhus, Central Jutland, Denmark
Tampa, Florida, United States
Blumenau, Santa Catarina, Brazil
Mexico City, , Mexico
München, Bavaria, Germany
Sapporo, Hokkaido, Japan
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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