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

Launched by INSMED INCORPORATED · Dec 6, 2022

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ClinConnect Summary

This clinical trial is looking at the long-term safety and tolerability of a medication called Treprostinil Palmitil Inhalation Powder (TPIP) for patients who have pulmonary hypertension related to interstitial lung disease (PH-ILD). If you or a loved one completed a previous study involving TPIP, you may be eligible to join this extension study. To participate, individuals should be between the ages of 65 and 74, have completed their earlier study visit, and be able to provide informed consent, which means understanding the study details and agreeing to participate.

Participants in this trial can expect to continue using TPIP while being closely monitored for any side effects or issues that may arise from long-term use. It's important to note that those who had a severe reaction to TPIP in previous studies or who have started other similar treatments since their last study may not be eligible. Additionally, women who are pregnant or breastfeeding cannot participate. This study is currently recruiting participants, so if you think you might qualify, it's a good idea to talk to your doctor about it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). 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 INS1009-211, or any other lead-in PH-ILD TPIP study.
• • 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.
• Exclusion Criteria:
• • Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
• • Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 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.
• • Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.
• • - Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.