A study to evaluate the effects of Treprostinil Palmitil Inhalation Powder in participants with Pulmonary Hypertension with Interstitial Lung Disease
- Conditions
- Pulmonary Hypertension Associated with Interstitial Lung DiseaseMedDRA version: 20.0Level: LLTClassification code: 10077732Term: Pulmonary hypertension WHO functional class II Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10077734Term: Pulmonary hypertension WHO functional class IV Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10077733Term: Pulmonary hypertension WHO functional class III Class: 10038738MedDRA version: 20.0Level: LLTClassification code: 10077731Term: Pulmonary hypertension WHO functional class I Class: 10038738Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-505540-19-00
- Lead Sponsor
- Insmed Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
1. Male and female participants who completed the end of treatment visit in Study INS1009-211, or any other lead-in PH-ILD 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. 2. 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. Requirements for baseline screening assessments are located in Section 4.1.1.1. of the Protocol 3. 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.
1. Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an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. 2. 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. 3. 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 (contraceptive guidance is located in Section 10.4). Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.2.4.2 and Section 8.3.5. 4. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method