Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06616974
Registration number
NCT06616974
Ethics application status
Date submitted
19/09/2024
Date registered
27/09/2024
Date last updated
15/04/2025
Titles & IDs
Public title
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Query!
Scientific title
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)
Query!
Secondary ID [1]
0
0
TX000045-003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
0
0
Query!
Heart Failure With Preserved Ejection Fraction
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Cardiovascular
0
0
0
0
Query!
Hypertension
Query!
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TX000045- Dose A
Treatment: Drugs - TX000045- Dose B
Treatment: Drugs - Placebo
Experimental: TX000045 Dose A - Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.
Experimental: TX000045 Dose B - Participants will receive alternating single doses of TX000045 Dose B and placebo subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.
Placebo comparator: Placebo - Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155
Treatment: Drugs: TX000045- Dose A
The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
Treatment: Drugs: 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.
Treatment: Drugs: Placebo
The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Query!
Assessment method [1]
0
0
Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
Query!
Timepoint [1]
0
0
Baseline up to Week 24 post first dose
Query!
Primary outcome [2]
0
0
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Baseline up to Week 30 post first dose
Query!
Primary outcome [3]
0
0
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline up to Week 30 post first dose
Query!
Primary outcome [4]
0
0
Number of participants with treatment-related adverse events.
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline up to Week 30 post first dose
Query!
Primary outcome [5]
0
0
Number of participants with changes in the physical examination findings.
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline to Week 30 post first dose
Query!
Secondary outcome [1]
0
0
Mean change from baseline in pulmonary capillary wedge pressure (PCWP).
Query!
Assessment method [1]
0
0
Measured by RHC between those who received TX000045 and those with placebo.
Query!
Timepoint [1]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [2]
0
0
Mean change from baseline in PVR for all participants.
Query!
Assessment method [2]
0
0
Measured by RHC between those who received TX000045 and those with placebo.
Query!
Timepoint [2]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [3]
0
0
Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH.
Query!
Assessment method [3]
0
0
This is measured by RHC between those who received TX000045 and those with placebo.
Query!
Timepoint [3]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [4]
0
0
Mean change from baseline in exercise capacity in all participants and in participants with CpcPH.
Query!
Assessment method [4]
0
0
This is measured by mean change from baseline in 6-minute walk test (6MWT) distance between those who received TX000045 and those with placebo.
Query!
Timepoint [4]
0
0
Baseline to Week 30 post first dose
Query!
Secondary outcome [5]
0
0
Mean change from baseline in total pulmonary resistance (TPR) for all participants and in participants with CpcPH.
Query!
Assessment method [5]
0
0
This is measured by RHC between those who received TX000045 and those with placebo.
Query!
Timepoint [5]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [6]
0
0
Mean change from baseline in mean pulmonary arterial pressure (mPAP) for all participants and in participants with CpcPH.
Query!
Assessment method [6]
0
0
This is measured by RHC between those who received TX000045 and those with placebo.
Query!
Timepoint [6]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [7]
0
0
Mean change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) for all participants and in participants with CpcPH between those who received TX000045 and those with placebo.
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Baseline to Week 30 post first dose
Query!
Secondary outcome [8]
0
0
Mean change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) for all participants and in participants with CpcPH.
Query!
Assessment method [8]
0
0
To evaluate the effect of TX000045 vs. Placebo on KCCQ scores. KCCQ-12 is a validated tool to assess quality of life in patients with heart failure. It contains 4 subdomains: physical limitation, symptom frequency, QOL, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status.
Query!
Timepoint [8]
0
0
Baseline to Week 24 post first dose
Query!
Secondary outcome [9]
0
0
Evaluate the serum concentrations of TX000045.
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose
Query!
Secondary outcome [10]
0
0
Number of participants with change in antibody titers following treatment with TX000045 (Immunogenicity).
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
83
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/10/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
20/11/2026
Query!
Actual
Query!
Sample size
Target
180
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Macquarie - Macquarie
Query!
Recruitment hospital [2]
0
0
Sydney - Sydney
Query!
Recruitment hospital [3]
0
0
Wollongong - Wollongong
Query!
Recruitment hospital [4]
0
0
Auchenflower - Auchenflower
Query!
Recruitment hospital [5]
0
0
Chermside - Chermside
Query!
Recruitment hospital [6]
0
0
Hobart - Hobart
Query!
Recruitment hospital [7]
0
0
Malvern - Malvern
Query!
Recruitment postcode(s) [1]
0
0
2109 - Macquarie
Query!
Recruitment postcode(s) [2]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [4]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [5]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [6]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [7]
0
0
3144 - Malvern
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Mississippi
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Texas
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Utah
Query!
Country [21]
0
0
Armenia
Query!
State/province [21]
0
0
Yerevan
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Brussel
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Genk
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Pleven
Query!
Country [25]
0
0
Bulgaria
Query!
State/province [25]
0
0
Plovdiv
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Sofia
Query!
Country [27]
0
0
Georgia
Query!
State/province [27]
0
0
Tb
Query!
Country [28]
0
0
Georgia
Query!
State/province [28]
0
0
Tbilisi
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Hamburg
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Mainz
Query!
Country [31]
0
0
Latvia
Query!
State/province [31]
0
0
Riga
Query!
Country [32]
0
0
Moldova, Republic of
Query!
State/province [32]
0
0
Chisinau
Query!
Country [33]
0
0
New Zealand
Query!
State/province [33]
0
0
Christchurch
Query!
Country [34]
0
0
New Zealand
Query!
State/province [34]
0
0
Dunedin
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Bialystok
Query!
Country [36]
0
0
Poland
Query!
State/province [36]
0
0
Kraków
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Lublin
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Warsaw
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Lódz
Query!
Country [40]
0
0
Romania
Query!
State/province [40]
0
0
Craiova
Query!
Country [41]
0
0
Romania
Query!
State/province [41]
0
0
Târgu-Mures
Query!
Country [42]
0
0
Spain
Query!
State/province [42]
0
0
Barcelona
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Madrid
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Santiago De Compostela
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Tectonic Therapeutic
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT06616974
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Robert Rogers, MD
Query!
Address
0
0
Tectonic Therapeutic
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Clinical Trials
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+1 339 337 4053
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06616974
Download to PDF