An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Sponsored by Insmed Incorporated
About this trial
Last updated a month ago
Study ID
Status
Type
Placebo
Accepting
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for PAH or PH-ILD. - Participant provides their informed consent to participate as per local requirements. - Participant must have successfully completed the OLE INS1009-203 or INS1009-212 studies. - Based on the treating physician's judgement on participant's medical history and an evaluation of the overall risk-benefit profile, the participant will be determined to be suitable for continued TPIP treatment within this program. - Requests for the post-OLE INS1009-203 and INS1009-212 TPIP studies must originate from the investigators of INS1009-203 and INS1009-212 TPIP studies, respectively. - Female participants must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (failure rate <1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose. - Male participants with female partners must adhere to contraception requirements to avoid potential exposure to the embryo/fetus based on the partner's reproductive status. For partners of childbearing potential, effective contraception must be used from Day 1 to at least 90 days after the last dose.
Exclusion Criteria
• No specific exclusion criteria.
For more information, view the full study details:
NCT06939647