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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TX000045 300 mg | Experimental | Participants will receive subcutaneous (SC) injection of TX000045 at a dose of 300 milligrams (mg) every 4 weeks (Q4W) from Week 1 up to Week 13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TX000045 | Drug | Subcutaneous Injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in PVR up to 16 Weeks | Baseline up to 16 weeks | |
| Number of Participants with Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) | 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 | Baseline up to 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline in Mean Pulmonary Arterial Pressure (mPAP) up to 21 Weeks | Baseline up to 21 weeks | |
| Mean Change from Baseline in Hemodynamic Parameter: Pulmonary Capillary Wedge Pressure (PCWP) | Baseline up to 21 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials | Contact | +1 339 337 4053 | ClinicalTrials@tectonictx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale, Arizona | Scottsdale | Arizona | 85258 | United States | ||
| Krakow |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| Mean Change from Baseline in Hemodynamic Parameter: Cardiac Output (CO) | Baseline up to 21 weeks |
| Mean Change from Baseline in Hemodynamic Parameter: Stroke Volume (SV) | Baseline up to 21 weeks |
| Mean Change from Baseline in Resting Arterial Oxygen Saturation (SpO2) up to 21 Weeks | Baseline up to 21 weeks |
| Mean Change from Baseline in Supplemental Oxygen Requirement (L/min) up to 21 Weeks | 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 | 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 | 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 | Baseline up to 21 weeks |
| Krakow |
| 31-202 |
| Poland |
| Bucharest | Bucharest | 022328 | Romania |
| Belgrade | Belgrade | 11000 | Serbia |
| Niš | Niš | 18000 | Serbia |
| Barcelona | Barcelona | 08002 | Spain |
| D002318 |
| Cardiovascular Diseases |