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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

TPIP PAH PTA

Status

Available

Type

Expanded Access

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

What is this trial about?

The purpose of this study is to provide continued access to TPIP for participants who have successfully completed the open-label extension (OLE) studies of INS1009-203 for PAH or INS1009-212 for PH-ILD.

What are the participation requirements?

Yes

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.

No

Exclusion Criteria

• No specific exclusion criteria.

For more information, view the full study details:

NCT06939647