Tiprelestat Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStanford University
About this trial
The primary objective of this study is to compare the efficacy, safety, and tolerability of tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients with World Health Organization (WHO) functional class II-IV pulmonary arterial hypertension (PAH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults age 18 to 75 years.
Willingness to give written informed consent prior to any study-related procedures being performed and to be able to adhere to the study restrictions and examination schedule.
Diagnosis of WHO Group I PAH.
WHO functional class II - IV despite optimized treatment SOC, with 1 or more modalities including phosphodiesterase 5 (PDE5) inhibitor, soluble guanylate cyclase stimulator (sGCS), endothelin receptor antagonist (ERA), and/or a prostacyclin analogue or receptor agonist (SC/inhaled/PO) (see #5), as well as Sotatercept (see #6).
Disqualifiers
Diagnosis of WHO Group 2 - 5 Pulmonary Hypertension.
Participation in another clinical trial, or experimental use, involving a PAH investigational drug or device within the last 3 months.
Total lung capacity (TLC) < 60% predicted; if TLC is ≥ 60% and < 70% predicted, high resolution computed tomography (HRCT) must be available to exclude significant interstitial lung disease.
FEV1 / FVC < 70% predicted and FEV1 < 60% predicted.
Trial design
Design model
Parallel
Treatments tested in this trial
Tiprelestat (5 mg)
Drug5 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.
Placebo (1 mL 0.9% saline solution)
DrugMatching 1 mL 0.9% saline solution administered as a daily subcutaneous injection for 168 days.
Tiprelestat (10 mg)
Drug10 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Tiprelestat (5 mg)Experimental treatment 1 intervention
Group B: Tiprelestat (10 mg)Experimental treatment 1 intervention
Group C: Placebo (1 mL 0.9% saline solution)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pulmonary Vascular Resistance (PVR)
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.
Time frame
Baseline to week 24Sponsors and contacts
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Stanford University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Michigan
Collaborator
Source ClinicalTrials.gov
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