EUCTR2020-004142-11-AT进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 284
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
- •1. Age = 18 years
- •2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:
- •Idiopathic PAH
- •Heritable PAH
- •Drug/toxin-induced PAH
- •PAH associated with connective tissue disease
- •PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- •3. Symptomatic pulmonary hypertension classified as WHO Functional Class II or III
- •4. Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of = 5 WU
- •5. At stable doses of background PAH therapy and diuretics (i.e., patientspecific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice.
- •6. 6MWD = 150 and = 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value)
- •7. Females of childbearing potential must:
- •Have 2 negative urine or serum pregnancy tests 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 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 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 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
- •Refrain from donating blood or sperm for the duration of the study and for 112 days (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 142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 142
排除标准
- •1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
- •2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group I should also include schistosomiasis APAH and pulmonary veno-occlusive disease
- •3. Hemoglobin (Hgb) at screening above gender-specific upper limit of normal, per local laboratory test
- •4. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during 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 visit:
- •eGFR < 30 mL/min/m2 (as defined by MDRD equation)
- •Serum alanine aminotransferase or aspartate aminotransferase levels
- •> 3 × upper limit of normal (ULN) or total bilirubin > 1.5 × ULN
- •8. 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
- •9. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536) or known allergic reaction to either one
- •10. Have full or partial pneumonectomy
- •11. Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing no more than mild interstitial lung disease (ILD) at the screening visit or 1 years prior to it
- •12. 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)
- •13. History of more than mild obstructive sleep apnea that is untreated
- •14. 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).
- •15. History of restrictive, constrictive or congestive cardiomyopathy
- •16. History of atrial septostomy within 180 days prior to the screening visit
- •17. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during screening visit
- •18. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death
- •19. Left ventricular ejection fraction (LVEF) < 45% on historical ECHO
- •within 6 months prior to the screening visit or pulmonary capillary wedge pressure (PCWP) > 15 mmHg as determined in the Screening Period RHC
- •20. 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. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
- •21. Cerebrovascular accident within 3 months prior to the screening visit
- •22. Acutely decompensated heart failure within 30 days prior to the screening visit, as per investigator assessment
- •23. Significant (= 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease.
- •24. Received intravenous inotropes (e.g., dobutami
研究者
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