Tiprelestat for Pulmonary Arterial Hypertension (PAH)
This study is testing a drug called Tiprelestat, given as a daily shot, for people with Pulmonary Arterial Hypertension (PAH). You would receive either Tiprelestat (5 mg or 10 mg) or a placebo (an inactive shot) in addition to your usual care. Researchers want to see if Tiprelestat can improve your Pulmonary Vascular Resistance (PVR), which is a measure of blood pressure in the lungs. This study is for adults aged 18 to 75 who have been diagnosed with WHO Group I PAH and are experiencing symptoms despite current treatments. The study aims to enroll 90 participants.
- Study design
- This is an interventional study comparing Tiprelestat to a placebo, with 90 planned participants. The phase of the study is not specified.
- What's involved
- Participants would receive a daily subcutaneous injection for 168 days. The primary endpoint, change in PVR, is measured from the start of the study to week 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at week 24, which is after the 168 days of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tiprelestat Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
At a glance
Conditions
NCT07601295
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brown University/Rhode Island Hospital
Providence, Rhode Islandno site contact published
Duke University
Durham, North Carolinano site contact published
Harvard University / Brigham and Women's Hospital
Boston, Massachusettsno site contact published
Stanford University
Stanford, Californiano site contact published
The University of Arizona / Banner University Medical Center
Tucson, Arizonano site contact published
University of California, San Francisco
San Francisco, Californiano site contact published
University of Colorado (UCD) Anschutz
Aurora, Coloradono site contact published
University of Pennsylvania
Philadelphia, Pennsylvaniano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Roham T Zamanian, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in Pulmonary Vascular Resistance (PVR)Baseline to week 24
PVR is calculated based on direct measurements during the right heart catheterization (RHC) procedure. PVR = (mPAP - PAWP) / CO, where mPAP is the mean pulmonary artery pressure, PAWP is the pulmonary wedge arterial pressure, and CO is the cardiac output. These cardiac measures are also obtained from right heart catheterization. PVR is measured in Wood units (WU) or dynes (dynes\*sec/cm5), and higher values are associated with more severe disease. Normal range for PVR is 1-3 WU (80-240 dynes\*sec/cm5) and can be as high as 30 WU (2,400 80-240 dynes\*sec/cm5) in disease.