EUCTR2021-000199-12-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 662
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Documented diagnostic right heart catheterization (RHC) within 6 months of screening documenting a minimum PVR of = 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of = 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes:
- •- Idiopathic PAH
- •- Heritable PAH
- •- Drug/toxin-induced PAH
- •- PAH associated with connective tissue disease
- •- PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- •3. Symptomatic PAH classified as WHO FC II or III
- •4. REVEAL Lite 2 risk score = 6
- •5. Diagnosis of PAH within 6 months of screening and on stable doses of a double combination of background PAH therapies for at least 90 days prior to screening. A triple combination of therapies, with stable doses for 90 days, may be allowed per local standard-of-care guidelines, but is restricted to 10% of the study population.
- •6. Six-minute walk distance = 150 m repeated twice at screening at least 4 hours apart, but no longer than 1 week apart, and both values are within 15% of each other (calculated from the highest value)
- •7. Females of childbearing potential must meet the following criteria:
- •-Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing urine or serum pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug -If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during
- •the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment -Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment
- •8. Male participants must meet the following criteria:
- •-Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for
- •at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
- •-Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of
- •study treatment
- •9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements
- •10. Ability to understand and provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 497
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 165
排除标准
- •1. Diagnosis of PAH WHO Groups 2, 3, 4, or 5
- •2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension
- •3. Hemoglobin at screening above gender-specific upper limit of normal (ULN), per local laboratory test
- •4. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg during the Screening Visit after a period of rest
- •5. Baseline systolic BP < 90 mmHg at screening
- •6. Pregnant or breastfeeding women
- •7. Any of the following clinical laboratory values at the Screening
- •-Estimated glomerular filtration rate < 30 mL/min/m2 (as defined by MDRD equation)
- •-Serum alanine aminotransferase or aspartate aminotransferase levels > 3 × ULN or total bilirubin > 1.5 × ULN -Platelet count < 50,000/mm3 (< 50.0 × 109/L)
- •8. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
- •9. Known allergic reaction to sotatercept (ACE-011)
- •10. History of pneumonectomy
- •11. Pulmonary function test values of forced vital capacity < 60% predicted within 1 year prior to the Screening Visit
- •12. Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g., diuretics, oxygen, anticoagulants, and
- •digoxin) within 60 days prior to the Screening Visit
- •13. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the Screening Visit or
- •planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible)
- •14. Untreated obstructive sleep apnea
- •15. History of known pericardial constriction
- •16. History of restrictive or congestive cardiomyopathy
- •17. History of atrial septostomy within 180 days prior to the Screening Visit
- •18. Electrocardiogram with Fridericia’s corrected QT interval > 450 ms (or > 500 ms if right bundle branch abnormality is present) during the Screening Period
- •19. Personal or family history of long QT syndrome or sudden cardiac death
- •20. Left ventricular ejection fraction < 50% on historical echocardiogram within 1 year prior to the Screening Visit or pulmonary capillary wedge pressure > 15 mmHg as determined by historical RHC within 6 months prior to the Screening Visit
- •21. Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) in the past 6 months prior to the Screening Visit
- •22. Cerebrovascular accident within 3 months prior to the Screening Visit
- •23. Acutely decompensated heart failure within 30 days prior to the Screening Visit, as per investigator assessment
- •24. Significant (= 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
- •25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, and vasopressin) within 30 days prior to the Screening Visit
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