RECRUITING

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

Conditions

Pulmonary Hypertension Heart Failure With Preserved Ejection Fraction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official 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)

Quick Facts

Study Start:2024-09-30

Study Completion:2026-11-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06616974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Is a male or female of non-childbearing potential between the ages of 18 and 80 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.	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 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 metersquare; 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 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.

Inclusion Criteria

Exclusion Criteria

1. Is a male or female of non-childbearing potential between the ages of 18 and 80 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.

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 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 metersquare;
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 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.

Contacts and Locations

Study Contact

Clinical Trials

CONTACT

+1 339 337 4053

ClinicalTrials@tectonictx.com

Principal Investigator

Marcie Ruddy, MD

STUDY_DIRECTOR

Tectonic Therapeutic

Study Locations (Sites)

Birmingham

Birmingham, Alabama, 35205

United States

Aurora

Aurora, Colorado, 80045

United States

Covington

Covington, Georgia, 70433

United States

Boston

Boston, Massachusetts, 02180

United States

Jackson

Jackson, Mississippi, 39216

United States

St Louis

Saint Louis, Missouri, 63110

United States

New York

New York, New York, 10029

United States

Durham

Durham, North Carolina, 27710

United States

Toledo

Toledo, Ohio, 43606

United States

Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

York

York, Pennsylvania, 17403

United States

Nashville

Nashville, Tennessee, 37205

United States

Beaumont

Beaumont, Texas, 77702

United States

Port Arthur

Port Arthur, Texas, 77642

United States

Collaborators and Investigators

Sponsor: Tectonic Therapeutic

Marcie Ruddy, MD, STUDY_DIRECTOR, Tectonic Therapeutic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2026-11-20

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2026-11-20

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Hypertension
Heart Failure With Preserved Ejection Fraction