The primary objective of this study is to measure the whether it is safe and how hard side effects are to live with of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
Official registry: https://clinicaltrials.gov/study/NCT07234032 · Insmed Incorporated · enrollment listed as 344
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Treprostinil Palmitil Inhalation Powder, or Placebo. The registry lists allocation as na. The primary objective of this study is to measure the whether it is safe and how hard side effects are to live with of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
They plan to enroll about 344 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease
Interventions: Treprostinil Palmitil Inhalation Powder, Placebo
Primary outcome (registry wording): Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Insmed Incorporated
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 10 sites outside the US on the same record
This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.
NCT00081523 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.
NCT01730092 · Official ClinicalTrials.gov record · National Institutes of Health Clinical Center (CC)
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs.
NCT02417740 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary