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临床试验/EUCTR2021-003020-32-SE
EUCTR2021-003020-32-SE招募中1 期

Phase 2, Double-blind, Randomized, Placebo-controlled 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., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA0 个研究点目标入组 150 人开始时间: 2021年11月10日最近更新:
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适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
150
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

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% in more than 2 consecutive measurements under stable conditions
  • •3. Demonstrated Cpc-PH by all of the following:
  • •Baseline RHC performed within 28 days of randomization documenting a minimum PVR = 320 dyn•sec/cm5 (4 wood units) (see Section 9.2.1 for historic RHC requirements)
  • •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 (see Section 9.3.2 for details)
  • •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. Women of childbearing potential (defined in Appendix 2) must:
  • •Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period; 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, with a male partner:
  • •- Use highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, AND
  • •- Agree to use the same highly effective contraception in combination with a barrier method 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 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 WOCBP 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 documented 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 37
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 113

排除标准

  • •1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
  • •2. Documented significant lung disease:
  • •- Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) < 60% predicted
  • •- Restrictive lung disease with total lung capacity < 70% predicted
  • •- More than mild interstitial lung disease (ILD), with FVC< 70% or FEV1< 60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging)
  • •3. Cardiovascular comorbidities, which include any of the following:
  • •-History of more than mild mitral or aortic stenosis (corrected mitral or aortic stenosis by a surgical or transcatheter method within 12 months from Visit 1 and no more than mild residual stenosis may be allowed after the Medical Monitor’s review)
  • •-Ongoing more than mild mitral or aortic regurgitation (corrected mitral or aortic regurgitation by a surgical or transcatheter method within 12 months from Visit 1 and no more than mild residual regurgitation may be allowed after the Medical Monitor’s review). NOTE: if an imaging report reads ‘mild-to-moderate mitral regurgitation', the participant may still be enrolled if, in the opinion of the
  • •investigator, the mitral regurgitation is no more than mild.
  • •-More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair.
  • •-Severe tricuspid regurgitation due to primary valvular disease (e.g., from endocarditis, carcinoid, or mechanical destruction).
  • •- Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1
  • •- History of serious life-threatening or hemodynamically significant arrhythmia
  • •- History of or anticipated heart transplant or ventricular assist device implantation
  • •- History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening
  • •- History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy
  • •- Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 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 (including atrial fibrillation)
  • •- Stroke within 90 days of Visit 1
  • •- Acutely decompensated HF that required hospitalization within 30 days of Visit 1
  • •- Electrocardiogram during Screening Period with Fridericia’s corrected QT interval (QTcF) > 470 msec for males or > 480 msec for females, or > 500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present
  • •- Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest
  • •- Personal or family history of long QT syndrome unless the subject’s ECG shows a normal QTc
  • •- Arrhythmogenic right ventricular dysplasia (ARVD) unless the subject has a recent cardiac MRI that shows no evidence of this diagnosis.
  • •4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1
  • •5. Received any approved PAH-specific therapies (i.e., endothelin

研究者

发起方
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA

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