Treprostinil Palmitil Inhalation Powder (TPIP) in Patients With Pulmonary Arterial Hypertension or Pulmonary Hypertension Associated With Interstitial Lung Disease

Insmed Incorporated0 个研究点开始时间: 2025年4月23日最近更新: 2026年6月10日

适应症

试验速览

阶段: 不适用
状态: Available
发起方: Insmed Incorporated

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•No specific exclusion criteria.

研究者

发起方

Insmed Incorporated

申办方类型

Industry

责任方

Sponsor

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