Phase 3 Pulmonary Hypertension Trial, Completed

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have had a right heart catheterization (a procedure to measure blood pressure in the lungs) at any point before the screening period, confirming a diagnosis of pulmonary arterial hypertension (PAH) — a condition where blood pressure in the lung arteries is abnormally high — in one of these specific forms: idiopathic PAH (no known cause), heritable PAH (genetic), PAH caused by a drug or toxin, PAH linked to a connective tissue disease, or PAH linked to a simple congenital heart defect that was surgically repaired at least one year ago
• People whose PAH symptoms fall into World Health Organization Functional Class II or III — meaning the condition causes some to significant limitation during physical activity
• People whose screening heart catheterization shows specific measurements of blood flow resistance and pressure in the lungs that meet the trial's thresholds (confirm exact values with trial site)
• People who have been on a stable dose of approved PAH medications and water tablets (diuretics) for at least 90 days before screening, with only minor adjustments allowed for certain infusion medications
• People who can walk between 150 and 500 metres in a 6-minute walk test, with two consistent results recorded at least 4 hours apart during the screening period
• Women who could become pregnant must have two negative pregnancy tests before starting the study drug, use highly effective contraception for at least 28 days before starting and for 16 weeks after finishing, and must not breastfeed or donate blood, eggs, or ovum during the study and for at least 16 weeks after the last dose
• Male participants must use a condom (latex or non-latex synthetic, not natural membrane) during sexual contact with a pregnant woman or a woman who could become pregnant, throughout the study and for at least 16 weeks after the last dose, and must not donate blood or sperm during the study or for 16 weeks after the last dose
• People who are able to attend all required study visits and follow the study instructions
• People who are able to understand the study and provide written consent to participate

Who may not be able to join:

• People whose pulmonary hypertension belongs to WHO Groups 2, 3, 4, or 5 — forms caused by other conditions such as left heart disease, lung disease, or blood clots
• People with PAH associated with HIV, portal hypertension, schistosomiasis (a parasitic infection), or a condition called pulmonary veno-occlusive disease
• People whose haemoglobin (a measure of red blood cells) is above the normal upper range for their gender at screening
• People with a very low platelet count (below 50,000/mm³) at screening
• People with uncontrolled high blood pressure — specifically a sitting systolic reading above 160 mmHg or diastolic above 100 mmHg during screening
• People with low blood pressure — specifically a sitting systolic reading below 90 mmHg at screening
• Women who are pregnant or breastfeeding
• People with severely reduced kidney function at screening (confirm specific threshold with trial site)
• People with significantly elevated liver enzyme or bilirubin levels at screening, unless they have a documented history of a condition called Gilbert's syndrome (which can naturally raise bilirubin)
• People currently enrolled in, or who have recently completed, another clinical trial involving an investigational drug — within 30 days for most drugs or within 5 half-lives for biological medicines
• People who have previously been treated with sotatercept or luspatercept, or who are known to have had an allergic reaction to either
• People who have had a full surgical removal of one lung
• People whose lung function test shows a forced vital capacity (a measure of how much air the lungs can hold) below 60% of the expected value, or — if no lung function test is available — whose chest CT scan shows more than mild scarring or inflammation of the lungs
• People who have started a cardiac or pulmonary rehabilitation exercise program within 90 days before screening, or who plan to start one during the study (people already in a stable, ongoing maintenance program who will continue throughout the study may still be considered eligible — confirm with trial site)
• People with moderate to severe obstructive sleep apnoea that is not being treated
• People with a known history of high blood pressure in the liver's portal vein, or chronic liver disease including active hepatitis B or C, with mild to severe liver impairment
• People with a history of restrictive, constrictive, or congestive cardiomyopathy (conditions where the heart muscle does not function properly)
• People who have had a procedure called atrial septostomy (a procedure to create an opening between the heart's upper chambers) within 180 days before screening
• People whose heart's electrical activity test (ECG) shows a specific measurement called QTcF above 500 milliseconds during screening
• People with a personal or family history of long QT syndrome or sudden cardiac death
• People whose heart pumping function (left ventricular ejection fraction) was below 45% on an echocardiogram (heart ultrasound) within the 6 months before screening
• People who have had a significant heart event — such as a heart attack, coronary artery procedure, bypass surgery, or cardiac chest pain — within 6 months before screening (note: chest pain alone may not be an exclusion if a coronary angiogram shows no blockages — confirm with trial site)
• People who have had a stroke within 3 months before screening
• People who have had an episode of acutely worsening heart failure within 30 days before screening, as assessed by the treating doctor
• People with significant leakage (rated 2+ or higher) of the mitral or aortic heart valves
• People who have received intravenous medications to support heart function (such as dobutamine, dopamine, norepinephrine, or vasopressin) within 30 days before screening

Important: Always verify eligibility with the trial site directly before applying.