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.
Phoenix
Phoenix, Arizona, United States
RECRUITINGSan Francisco
San Francisco, California, United States
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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Idaho
Idaho Falls, Idaho, United States
NOT_YET_RECRUITINGAllen Park
Allen Park, Michigan, United States
NOT_YET_RECRUITINGKrakow
Krakow, Poland
NOT_YET_RECRUITINGLublin
Lublin, Poland
NOT_YET_RECRUITINGWroclaw
Wroclaw, Poland
NOT_YET_RECRUITINGBucharest
Bucharest, Romania
NOT_YET_RECRUITINGBelgrade
Belgrade, Serbia
NOT_YET_RECRUITINGSremska Kamenica
Kamenitz, Serbia
NOT_YET_RECRUITING...and 6 more locations
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