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
Qualifiers
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
Treatments tested in this trial
- Tiprelestat (5 mg)
- Placebo (1 mL 0.9% saline solution)
- Tiprelestat (10 mg)
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Michigan
Collaborator
Source ClinicalTrials.gov