EUCTR2021-001498-21-IT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- •Eligible participants must meet all of the following inclusion criteria to
- •be enrolled in the study:
- •1. Age 18 to 75 years, inclusive
- •2. Documented diagnostic right heart catheterization prior to screening
- •confirming the diagnosis of WHO PAH Group 1 in any of the following
- •Idiopathic PAH
- •Heritable PAH
- •Drug/toxin-induced PAH
- •PAH associated with CTD
- •PAH associated with simple, congenital systemic-to-pulmonary shunts
- •at least 1 year following repair
- •3. Symptomatic PAH classified as WHO FC III or IV
- •4. REVEAL Lite 2 risk score of = 10
- •5. Right heart catheterization performed during screening (or within 2
- •weeks prior to screening, if done at the clinical study site) documenting
- •a minimum PVR of = 5 Wood units and a pulmonary capillary wedge
- •pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of =
- •6. Clinically stable and on stable doses of maximum tolerated (per
- •investigator's judgment) double or triple background PAH therapies for
- •at least 30 days prior to screening
- •7. Females of childbearing potential must:
- •Have 2 negative urine or serum pregnancy tests as verified by the
- •investigator prior to starting study therapy; 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 least28 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:
- •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 83
- 另有 2 项未显示
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-associated PAH and PAH associated
- •with portal hypertension
- •3. Diagnosis of pulmonary veno-occlusive diseases or pulmonary
- •capillary hemangiomatosis or overt signs of capillary and/or venous
- •involvement
- •4. Hemoglobin at screening above gender-specific upper limit of
- •normal (ULN), per local laboratory test
- •5. Baseline platelet count < 50,000/mm3 (< 50.0 x 109/L) at
- •6. Baseline systolic blood pressure < 85 mmHg at screening
- •7. Pregnant or breastfeeding women
- •8. Any of the following clinical laboratory values at the Screening
- •Estimated glomerular filtration rate < 30 mL/min/m2 (as
- •defined by the Modification of Diet in Renal Disease Study
- •Serum alanine aminotransferase or aspartate aminotransferase levels
- •> 3 × ULN or total bilirubin > 2.0 × ULN
- •9. Currently enrolled in or have completed any other investigational
- •product study within 30 days for small-molecule drugs or within 5 halflives
- •for biologics prior to the date of signed informed consent
- •10. Prior exposure to or known allergic reaction to sotatercept
- •(ACE-011) or luspatercept (ACE-536)
- •11. History of pneumonectomy
- •12. Pulmonary function test values of forced vital capacity < 60%
- •predicted within 1 year prior to the Screening Visit
- •13. Untreated obstructive sleep apnea
- •14. History of known pericardial constriction
- •15. History of restrictive or congestive cardiomyopathy
- •16. Electrocardiogram (ECG) with Fridericia's corrected QT interval
- •(QTcF) > 450 ms (or > 500 ms if right bundle branch block is present)
- •during the Screening Period
- •17. Personal or family history of long QT syndrome or sudden cardiac
- •18. Left ventricular ejection fraction < 50% on historical echocardiogram
- •within 1 year prior to the Screening Visit
- •19. 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
- •20. Cerebrovascular accident within 3 months prior to the Screening
- •21. Significant (= 2+ regurgitation) mitral regurgitation or aortic
- •regurgitation valvular disease
研究者
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