An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07234032 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344
Last updated 2025-11-18
Summary
The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
Conditions
- Pulmonary Hypertension
- Interstitial Lung Disease
Interventions
- DRUG
-
Treprostinil Palmitil Inhalation Powder
Oral inhalation using a capsule-based dry powder.
- DRUG
-
Oral inhalation in initial double-dummy titration period.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-01
- Primary Completion
- 2031-01-22
- Completion
- 2031-01-22
- FDA Drug
- Yes
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