Clinical Trials in South Korea / NCT07234032
Recruiting
Phase 3
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07234032 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Pulmonary HypertensionInterstitial Lung Disease
Investigational drug(s) / intervention(s)
Treprostinil Palmitil Inhalation Powder: Oral inhalation using a capsule-based dry powder.
Placebo: Oral inhalation in initial double-dummy titration period.
Study 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).
Eligibility
Inclusion Criteria
* Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).
* Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.
Exclusion Criteria
* Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.
* Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.
* Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).
* Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.
* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
- Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs) — Up to 108 weeks
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| USA006 | Naples | Florida | Recruiting |
| USA003 | Bend | Oregon | Recruiting |
| JPN004 | Narita | Chiba | Not Yet Recruiting |
| KOR001 | Seoul | South Korea | Not Yet Recruiting |
| KOR006 | Seoul | South Korea | Not Yet Recruiting |
| ESP006 | Madrid | Spain | Not Yet Recruiting |
| ESP003 | Madrid | Spain | Not Yet Recruiting |
| ESP001 | Seville | Spain | Not Yet Recruiting |
| TWN003 | Hsinchu | Taiwan | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07234032 on ClinicalTrials.gov ↗ ← All trials in South Korea