A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Prese… (NCT06616974) | Clinical Trial Compass
RecruitingPhase 2
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
United States180 participantsStarted 2024-09-04
Plain-language summary
TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
Who can participate
Age range18 Years – 83 Years
SexALL
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Inclusion criteria
✓. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
✓. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
✓. Has NYHA functional class II- III heart failure.
✓. Has 6MWT distance from 100 to 450m.
✓. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
✓. Is able to understand and provide documented consent for participation.
Exclusion criteria
✕. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
✕. Current or recent hospitalization prior to screening.
✕. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
✕. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
✕. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
✕. Was previously administered TX000045, relaxin, or a relaxin fusion protein.
✕
What they're measuring
1
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Timeframe: Baseline up to Week 24 post first dose
2
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
Timeframe: Baseline up to Week 30 post first dose
3
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Timeframe: Baseline up to Week 30 post first dose
4
Number of participants with treatment-related adverse events.
Timeframe: Baseline up to Week 30 post first dose
5
Number of participants with changes in the physical examination findings.
. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
✕. Has any of the following clinical laboratory values during screening: