A Post Trial Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH)

Insmed

Status

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Treprostinil Palmitil

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT06939647

TPIP PAH PTA

Details and patient eligibility

About

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

Full description

Participants will receive TPIP 80 micrograms (μg), 160 μg, or 320 μg, inhalation single-dose capsules, orally, once daily (QD).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• The participant is ineligible for or cannot be treated satisfactorily with alternative commercially available therapy for the PAH.
• Participant provides their informed consent to participate as per local requirements.
• Participant must have successfully completed the OLE INS1009-203 Study.
• 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 TPIP Study must originate from the investigator of INS1009-203 TPIP Study.
• 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.