EUCTR2017-004738-27-GB进行中（未招募）1 期
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
入选标准
- •Participants must satisfy all of the following criteria to be enrolled in the study:
- •1. Age =18 years
- •2. Documented diagnostic right heart catheterization (RHC) at any time prior to Screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of the following subtypes:
- •o Idiopathic or heritable PAH
- •o Drug- or toxin-induced PAH
- •o PAH associated with connective tissue disease
- •o PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair
- •3. Symptomatic pulmonary hypertension classified as WHO functional class II or III
- •4. Screening RHC documenting a minimum PVR of = 400 dyn·sec/cm5 (5 Wood units)
- •5. Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:
- •a. Total lung capacity (TLC) > 70% predicted; or if between 60-70% predicted, confirmatory high-resolution computed tomography indicating no more than mild interstitial lung disease (ILD)
- •b. Forced expiratory volume (first second) (FEV1)/ forced vital capacity (FVC) > 70% predicted
- •6. Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram [CTPA] result), any time prior to Screening with normal or low probability result
- •7. No contraindication per investigator for RHC during the study
- •8. 6MWD = 150 and = 450 meters repeated twice at Screening and both values within 15% of each other, calculated from the highest value
- •9. PAH therapy at stable (per investigator) dose levels of SOC therapies as defined in the protocol for at least 90 days prior to C1D1.
- •10. Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 months), must:
- •a. Have two negative pregnancy tests as verified by the investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of C1D1). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.
- •b. If sexually active, agree to use, and be able to comply with, highly effective contraception** without interruption, 5 weeks prior to starting investigational product during the study therapy (including dose interruptions), and for 16 weeks after discontinuation of study treatment.
- •c. Refrain from breastfeeding a child, donating blood, eggs, or ovum for the duration of the study and for at least 112 days after the last dose of study treatment.
- •** Highly effective contraception is defined in this protocol as the following (information will also appear in the ICF): Hormonal contraception (for example, birth control pills, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a partner with a vasectomy who has completed follow-up to confirm a successful procedure
- •Male participants must:
- •a. Agree to use a condom, defined as
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •1. Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g, diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to C1D1
- •2. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to C1D1
- •3. History of atrial septostomy within 180 days prior to Screening
- •4. History of more than mild obstructive sleep apnea that is untreated
- •5. Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
- •6. History of human immunodeficiency virus infection-associated PAH
- •7. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)
- •8. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to C1D1 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).
- •9. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg during Screening after a period of rest
- •10. Systolic BP < 90 mmHg during Screening or at baseline
- •11. History of known pericardial constriction
- •12. ECG with QTcF >480 msec during Screening Period or C1D1
- •13. History of personal or family history of long QTc syndrome or sudden cardiac death
- •14. History of recent cerebrovascular accident (CVA) within 3 months of C1D1
- •15. History of restrictive or congestive cardiomyopathy
- •16. Left ventricular ejection fraction (LVEF) < 45% on historical echocardiogram (ECHO) within 6 months prior to screening or pulmonary capillary wedge pressure (PCWP) > 15 mmHg on right heart catheterization during baseline evaluation
- •17. 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)
- •18. Acutely decompensated heart failure within 30 days prior to C1D1, as per investigator assessment
- •19. Significant (= 2+ regurgitation) mitral regurgitation (MR) or aortic regurgitation (AR) valvular disease
- •20. Any of the following clinical laboratory values during the Screening Period prior to C1D1:
- •a. Baseline Hgb > 15 g/dL for women; > 16 g/dL for men within 28 days of C1D1
- •b. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3X upper limit of normal (ULN) or total bilirubin > 1.5X ULN within 28 days of C1D1
- •c. White blood cell (WBC) count < 4000/mm3
- •d. Platelets < 100,000/µL
- •e. Absolute neutrophil count (ANC) < 1500/mm3
- •21. History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to Screening; serious local infection (e.g., cellulitis, abscess) or systemic infe
研究者
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