Pulmonary HypertensionHeart Failure With Preserved Ejection Fraction
Investigational drug(s) / intervention(s)
TX000045- Dose ATX000045- Dose BPlacebo
TX000045- Dose A: The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
TX000045- Dose B: The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
Placebo: The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
83 Years
Healthy volunteers
No
Inclusion Criteria:
1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
3. Has NYHA functional class II- III heart failure.
4. Has 6MWT distance from 100 to 450m.
5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
6. Is able to understand and provide documented consent for participation.
Exclusion Criteria:
1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
2. Current or recent hospitalization prior to screening.
3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
6. Was previously administered TX000045, relaxin, or a relaxin fusion protein.
7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
8. Has any of the following clinical laboratory values during screening:
1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN;
2. eGFR \<30 mL/min/1.73 m2;
3. HbA1c (glycosylated hemoglobin) \>9%;
4. Platelet count \<50,000/millimeter cube;
5. Hemoglobin \<10.0g/dL;
9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
10. Is pregnant or breastfeeding.
11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
12. Has a history of drug or alcohol abuse.
13. Was recently dosed in any clinical research study.
Primary outcome measure(s)
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). — Baseline up to Week 24 post first dose Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs. — Baseline up to Week 30 post first dose
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment. — Baseline up to Week 30 post first dose
Number of participants with treatment-related adverse events. — Baseline up to Week 30 post first dose
Number of participants with changes in the physical examination findings. — Baseline to Week 30 post first dose
Trial sites (72)
Facility
City
Region
Status
Phoenix
Phoenix
Arizona
Scottsdale
Scottsdale
Arizona
San Francisco
San Francisco
California
Santa Rosa
Santa Rosa
California
Aurora
Aurora
Colorado
Jacksonville
Jacksonville
Florida
Augusta
Augusta
Georgia
McDonough
McDonough
Georgia
Boise
Boise
Idaho
USA
Louisville
Kentucky
Baltimore
Baltimore
Maryland
Boston
Boston
Massachusetts
Minneapolis
Minneapolis
Minnesota
St Louis
St Louis
Missouri
Omaha
Omaha
Nebraska
New York
New York
New York
New York
New York
New York
Durham
Durham
North Carolina
Philadelphia
Philadelphia
Pennsylvania
Pittsburgh
Pittsburgh
Pennsylvania
York
York
Pennsylvania
Port Arthur
Port Arthur
Texas
Waco
Waco
Texas
Salt Lake City
Salt Lake City
Utah
United States
Norfolk
Virginia
Yerevan
Yerevan
Armenia
Yerevan
Yerevan
Armenia
Yerevan
Yerevan
Armenia
Camperdown
Camperdown
New South Wales
Macquarie
Macquarie
New South Wales
New Lambton
New Lambton
New South Wales
Sydney
Sydney
New South Wales
Wollongong
Wollongong
New South Wales
Chermside
Chermside
Queensland
Hobart
Hobart
Tasmania
Malvern
Malvern
Victoria
Camperdown
Camperdown
Australia
New Lambton
New Lambton
Australia
Austria
Vienna
Austria
Brussel
Brussels
Belgium
+ 32 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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