An Open-Label Study to Assess the Hemodynamic Effect and the Safety of TX000045 After 16 Weeks of Treatment in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Tectonic Operating Company, Inc.
Summary
The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and tolerability of TX000045 in participants with PH-ILD.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed diagnosis of ILD based on imaging: chest computed tomography (CT) performed within the past 12 months with fibrotic lung disease (greater than or equal to (\>=) 10 percent (%) lung parenchyma with fibrosis) consistent with idiopathic interstitial pneumonia, ILD in association with connective tissue disease, occupational ILD, or chronic hypersensitivity pneumonitis. Chest CTs will be centrally read for eligibility * 40% predicted less than or equal to (\<=) forced vital capacity (FVC) \<= 80% predicted at screening * At least ONE of the following is required to…
Interventions
- DrugTX000045
Subcutaneous Injection.
Locations (6)
- Scottsdale, ArizonaScottsdale, Arizona
- KrakowKrakow
- BucharestBucharest
- BelgradeBelgrade
- NišNiš
- BarcelonaBarcelona