Trials
Search / Trial NCT05649748

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 February 05, 2025

Recruiting

Keywords

Treprostinil Palmitil

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.

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

Tsukuba, Ibaraki, Japan

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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