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临床试验/EUCTR2021-003020-32-ES
EUCTR2021-003020-32-ES进行中（未招募）1 期

Phase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) - A Phase 2 Study of Sotatercept for Cpc-PH Treatment

Acceleron Pharma Inc.0 个研究点目标入组 180 人开始时间: 2021年10月19日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
180
研究概览入排标准研究者记录与标识符相似试验

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

  • •Participants must meet the following criteria to be enrolled in this study:
  • •1. Age 18 to 85 years
  • •2. Clinical diagnosis of HFpEF:
  • •Left ventricular ejection fraction = 50%, with no history of LVEF below 45%
  • •3. Demonstrated Cpc-PH by all of the following:
  • •Baseline RHC performed within 10 days prior to Visit 1 (during the Screening
  • •Period) documenting a minimum PVR = 320 dyn•sec/cm5 (4 wood units)
  • •Mean pulmonary arterial pressure > 20 mmHg
  • •Pulmonary capillary wedge pressure > 15 mmHg but < 30 mmHg
  • •4. New York Heart Association FC of II or III
  • •5. Six-Minute Walk Distance = 100 meters repeated twice during Screening and both values
  • •within 15% of each other, calculated from the highest value
  • •6. Chronic medication for HF or for any underlying condition, administered at a stable (per
  • •investigator) dose for = 30 days prior to Visit 1. Diuretics and/or anticoagulants are
  • •excepted from this rule but should not be newly started or stopped within 30 days of
  • •Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1.
  • •Anticoagulation may be suspended for RHC if necessary.
  • •7. Females of childbearing potential (defined in Appendix 2) must:
  • •Have a negative pregnancy test as verified by the investigator prior to starting study
  • •drug administration; she must agree to ongoing 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 continue 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 drug
  • •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 drug
  • •See Appendix 2 for additional contraceptive information.
  • •8. Male participants must:
  • •Agree to use a condom, defined as a male latex condom or non-latex 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 (see Appendix 2 for additional contraceptive information)
  • •Refrain from donating blood or sperm for the duration of the study and for 16 weeks
  • •(112 days) after the last dose of study drug
  • •9. Ability to adhere to the study visit schedule and understand and comply with all protocol
  • •requirements
  • •10. Agreement to not participate in any other trials of investigational drugs/devices while
  • •enrolled in the A011-16 study
  • •11. Ability to understand and provide written informed consent for participation
  • •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 45
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 135

排除标准

  • •1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
  • •2. Significant parenchymal lung disease (e.g., chronic obstructive pulmonary disease with
  • •Global Initiative for Obstructive Lung Disease (GOLD) criteria III and IV, moderate or
  • •severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary
  • •thromboembolism)
  • •3. Cardiovascular co-morbidities, which include any of the following:
  • •Any history of greater than mild mitral regurgitation or aortic regurgitation valvular
  • •disease or greater than mild aortic or mitral stenosis
  • •Acute coronary syndrome, coronary artery bypass graft or percutaneous coronary
  • •intervention within 180 days of Visit 1
  • •Uncontrolled heart rate (> 100 bpm) from atrial fibrillation or atrial flutter
  • •History of serious life-threatening or hemodynamically significant arrhythmia
  • •History of or anticipated heart transplant or ventricular assist device implantation
  • •History of or anticipated implantation of pacemaker or implantable cardioverter
  • •defibrillator
  • •Occurrence of myocardial infarction within 90 days of Visit 1
  • •History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis,
  • •or amyloid cardiomyopathy
  • •Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
  • •>1 60 mmHg or sitting diastolic blood pressure > 110 mmHg during Screening after a
  • •period of rest
  • •Systemic hypotension as evidenced by sitting systolic blood pressure < 90 mmHg or
  • •sitting diastolic blood pressure < 50 mmHg during Screening
  • •Resting heart rate of < 45 bpm or > 115 bpm
  • •Cerebrovascular accident within 90 days of Visit 1
  • •Acutely decompensated HF within 45 days prior to Visit 1, as per investigator
  • •Electrocardiogram during Screening Period with Fridericia’s corrected QT interval
  • •(QTcF) > 480 msec or > 500 msec if a ventricular conduction defect (right bundle
  • •branch block; left bundle branch block; or interventricular conduction delay) is
  • •Personal or family history of long corrected QT syndrome or sudden cardiac death in
  • •first-degree relative
  • •4. Hospitalization for any indication within 30 days of Visit 1
  • •5. Received any approved PAH-specific therapies, i.e., endothelin receptor antagonists,
  • •prostacyclin analogs, phosphodiesterase-5 inhibitors, or a soluble guanylate cyclase
  • •stimulator, within 30 days prior to Visit 1
  • •6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine,
  • •vasopressin) within 30 days prior to Visit 1
  • •7. Received erythropoietin within 6 months prior to Visit 1
  • •8. Known history of chronic liver disease, including untreated 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 to C)
  • •9. Prior exposure to sotatercept or luspatercept
  • •10. 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
  • •11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior
  • •to Visit 1 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
  • •12. Any of the following clinical laboratory values prior to Visit 1 as specified:
  • •Hemoglobin above the gender-specific upper limit of normal (ULN) per local
  • 另有 1 项未显示

研究者

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