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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Subcutaneous Injection.
Scottsdale, Arizona
Scottsdale, Arizona, United States
Krakow
Krakow, Poland
Bucharest
Bucharest, Romania
Belgrade
Belgrade, Serbia
Niš
Mean Change from Baseline in PVR up to 16 Weeks
Time frame: Baseline up to 16 weeks
Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 21 weeks
Number of Participants with Clinically Significant Changes from Baseline in Safety Laboratory Assessments, 12-Lead Electrocardiogram (ECG) Assessments and Vital Sign Assessments
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO)
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV)
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in the Nadir of the SpO2 During the 6-minute walk test (6MWT) up to 21 Weeks
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Niš, Serbia
Barcelona
Barcelona, Spain
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Oxygen Saturation (SpO2)at 1, 2, and 3 Minutes after Completion of the 6-MWT up to 21 Weeks
Time frame: Baseline up to 21 weeks
Mean Change from Baseline in Distance Walked During the 6MWT at Which an Absolute Decrease of SpO2>4% for At least 15 Second
Time frame: Baseline up to 21 weeks