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An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

RecruitingPhase 3Ages 18 Years - anyAllInsmed Incorporated
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria * Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380). * Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study. Exclusion Criteria * Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant. * Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed. * Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema). * Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). Note: Other protocol-defined inclusion/exclusion criteria may apply.
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What it tests

  • Treprostinil Palmitil Inhalation Powder
  • Placebo
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Where

9 sites
USA006
Naples, United States
USA003
Bend, United States
JPN004
Narita, Japan
KOR001
Seoul, South Korea
KOR006
Seoul, South Korea
ESP006
Madrid, Spain
ESP003
Madrid, Spain
ESP001
Seville, Spain

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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