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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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

Conditions

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Pulmonary Arterial Hypertension Pulmonary Hypertension, Interstitial Lung Disease

Interventions

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Treprostinil Palmitil

Treprostinil Palmitil Inhalation Powder

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Insmed Medical Information

Role: CONTACT

Phone: 18444467633

Email: [email protected]

Other Identifiers

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TPIP EAP

Identifier Type: -

Identifier Source: org_study_id