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

Korábbi kezelés

• Current or recent hospitalization prior to screening.
• Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
• Was previously administered TX000045, relaxin, or a relaxin fusion protein.

Más betegség

• Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
• History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
• Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
• Has a history of drug or alcohol abuse.

Laborértékek

• Has any of the following clinical laboratory values during screening:
  • Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x the upper limit of normal (ULN) or total bilirubin > 3 x ULN;
  • eGFR <30 mL/min/1.73 m2;
  • HbA1c (glycosylated hemoglobin) >9%;
  • Platelet count <50,000/millimeter cube;
  • Hemoglobin <10.0g/dL;

Egyéb

• Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
• 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.
• Is pregnant or breastfeeding.
• Was recently dosed in any clinical research study.

• 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.