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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525810-80-00
Enrollment
3
Registered
2026-07-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary hypertension secondary to interstitial lung disease

Brief summary

1. Mean change from baseline in PVR after 16 weeks of treatment., 2. Incidence of AEs, AESIs, and SAEs, 3. Clinically significant changes from baseline in safety laboratory assessments including clinical chemistry, hematology, urinalysis, 12-lead ECG assessments, and vital sign assessments over the course of the study.

Detailed description

1. Mean change from baseline in mPAP after 16 weeks of treatment, 2. Mean change from baseline in several hemodynamic parameters, including but not limited to CO and SV, after 16 weeks of treatment., 3. Mean change from baseline in resting arterial SpO2 over the course of the study., 4. Mean change from baseline in supplemental oxygen requirement (L/min) at rest over the course of the study., 5. Mean change from baseline in the nadir of the SpO2 during the 6MWT over the course of the study., 6. Mean change from baseline in SpO2 at 1, 2, and 3 minutes after completion of the 6MWT over the course of the study., 7. Mean change from baseline in the distance walked during the 6MWT at which there is an absolute decrease of SpO2 >4% for at least 15 seconds over the course of the study.

Interventions

Sponsors

Tectonic Operating Company Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Mean change from baseline in PVR after 16 weeks of treatment., 2. Incidence of AEs, AESIs, and SAEs, 3. Clinically significant changes from baseline in safety laboratory assessments including clinical chemistry, hematology, urinalysis, 12-lead ECG assessments, and vital sign assessments over the course of the study.

Secondary

MeasureTime frame
1. Mean change from baseline in mPAP after 16 weeks of treatment, 2. Mean change from baseline in several hemodynamic parameters, including but not limited to CO and SV, after 16 weeks of treatment., 3. Mean change from baseline in resting arterial SpO2 over the course of the study., 4. Mean change from baseline in supplemental oxygen requirement (L/min) at rest over the course of the study., 5. Mean change from baseline in the nadir of the SpO2 during the 6MWT over the course of the study., 6. Mean change from baseline in SpO2 at 1, 2, and 3 minutes after completion of the 6MWT over the course of the study., 7. Mean change from baseline in the distance walked during the 6MWT at which there is an absolute decrease of SpO2 >4% for at least 15 seconds over the course of the study.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 18, 2026