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A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514283-40-00
Acronym
TX000045-003
Enrollment
181
Registered
2024-11-28
Start date
2024-12-19
Completion date
Unknown
Last updated
2025-12-19

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

Conditions

Pulmonary Hypertension

Brief summary

Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo, In participants who received TX000045 compared with placebo, describe: • Incidence of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) • Incidence of clinically significant changes from baseline in laboratory assessments, 12-lead electrocardiogram (ECG), vital sign assessments, and physical examinations

Detailed description

Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo

Interventions

DRUGsterile isotonic solution

Sponsors

Tectonic Therapeutic Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo

Primary

MeasureTime frame
Mean change from baseline to Week 24 in PVR as measured by right heart catheterization (RHC) in participants with baseline PVR ≥3 Wood units who received TX000045 compared with those who received placebo, In participants who received TX000045 compared with placebo, describe: • Incidence of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) • Incidence of clinically significant changes from baseline in laboratory assessments, 12-lead electrocardiogram (ECG), vital sign assessments, and physical examinations

Countries

Austria, Belgium, Bulgaria, Germany, Latvia, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026