Treprostinil Palmitil for Pulmonary Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Study Director
Principal Investigator
Insmed Incorporated
Are You a Good Fit for This Trial?
This trial is for people with pulmonary hypertension linked to interstitial lung disease who have already finished a previous related study (INS1009-311). Participants must be able to give consent and agree not to join other clinical trials during this study.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Treprostinil Palmitil Inhalation Powder
Trial Overview
The study is testing the long-term safety of Treprostinil Palmitil Inhalation Powder (TPIP) compared to placebo in people with PH-ILD. All participants previously took part in an earlier TPIP trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants transitioning from study INS1009-311 (NCT07179380) will undergo an initial double-dummy titration with the stable dose from the lead-in study and either TPIP or placebo for 4 weeks. They will then receive open-label TPIP at a stable maintenance dose with optional escalation (80-1280 micrograms once daily) for the remainder of the 104-week treatment period.
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Who Is Running the Clinical Trial?
Insmed Incorporated
Lead Sponsor
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