EUCTR2021-000199-12-DE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
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA0 个研究点目标入组 444 人开始时间: 2021年8月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 444
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 12 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 CTD
- •- 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. Either REVEAL Lite 2 risk score = 6 or COMPERA 2.0 risk score = 2
- •(intermediate-low-risk or above)
- •5. Diagnosis of PAH within 12 months of screening and on stable doses of a double or triple combination of background PAH therapies and diuretics (if any) for at least 90 days prior to screening. Background PAH therapy and diuretics are further defined in Section 7.2.
- •6. 6MWD= 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 (as defined in Appendix 4) must meet the following criteria:
- •Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period;
- •Agree to ongoing pregnancy testing (either urine or serum) 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:
- •- Used highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, AND
- •- Agreed 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 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 documented 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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 164
排除标准
- •1. Diagnosis of pulmonary hypertension (PH) WHO Groups 2, 3, 4, or 5
- •2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis.
- •3. Hgb 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) > 180 mmHg or sitting diastolic BP > 110 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 (eGFR) < 30 mL/min/1.73 m2 (as defined by MDRD equation)
- •-Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 3 × ULN (For United Kingdom [UK], refer to the specific requirement in Appendix 6).
- •-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 investigational biologics prior to the date of documented informed consent
- •9. Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
- •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 PH 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 more than mild obstructive sleep apnea
- •15. History of known pericardial constriction
- •16. History of restrictive cardiomyopathy
- •17. History of atrial septostomy within 180 days prior to the Screening Visit
- •18. Electrocardiogram (ECG) with Fridericia's corrected QT interval > 500 ms during the Screening Period (For UK and South Korea, refer to the specific requirements in Appendix 6).
- •19. Personal or family history of long QT syndrome or sudden cardiac death
- •20. Left ventricular ejection fraction < 50% documented by a historical echocardiograph (ECHO) or cardiac magnetic resonance imaging (MRI) within the last 12 months prior to screening (if there is more than 1 assessment of left ventricular ejection fraction (LVEF), the value from the most recent measurement should be used in assessing eligibility)
- •21. Coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 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
- •26. Active malignancy with the exception of
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