PER-053-18尚未招募未知
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF JTT 251 ADMINISTERED FOR 24 WEEKS TO PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION (RELIEF–PAH)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
入选标准
- •1. Male or female, age 18 to 80 years (inclusive), at the Screening Visit;
- •2. A clinical diagnosis of PAH as classified by idiopathic, heritable, drug and toxin-induced, congenital heart disease or associated with connective tissue disease [i.e., World Health Organization (WHO) Group 1 with exceptions];
- •3. Participants must have a clinical diagnosis of PAH confirmed by right heart catheterization (RHC) at any time prior to the Screening Visit with results that are as follows:
- •Resting mean pulmonary arterial pressure (mPAP) >25 mmHg and
- •PVR >240 dyn·s/cm5 and
- •Pulmonary artery wedge pressure (PAWP) >15 mmHg or left ventricular end diastolic pressure (LVEDP) >15 mmHg;
- •Note: If both PAWP and LVEDP are not available, participants must have less than 3 of the following left heart disease risk factors:
- •a. Body mass index ≥30 kg/m2
- •b. History of essential hypertension
- •c. Diabetes mellitus (any type)
- •d. Historical evidence of significant coronary artery disease (CAD) established by any of the following:
- •History of myocardial infarction;
- •History of percutaneous coronary intervention;
- •Angiographic evidence of CAD (>50% stenosis in ≥1 vessel);
- •Previous coronary artery bypass grafting;
- •Stable angina.
- •If 3 or more of the above left heart disease risk factors are present, the left atrial volume index must be < 34 mL/m2 by screening echocardiogram as assessed by the echocardiography core laboratory per American Society of Echocardiography 2015 recommendations.
- •4. Participants with a WHO functional status of Class II-IV at the Screening Visit;
- •5. Participants must have two six minute walk distance (6MWD) test measurements between 100 and 450 m with a relative difference of <15%. The baseline 6MWD test must be performed at Visit 2 before randomization;
- •6.Participants must have a qualifying RHC performed during the Screening Period with the following results:
- •Resting mPAP > 25 mmHg and
- •PVR > 400 dyn·s/cm5 and
- •PAWP <15 mmHg
- •Note: If PAWP is not available, or there is discrepancy with the clinical data, then LVEDP must be <15 mmHg, as measured by left heart catheterization. These measurements will be used as the participant’s RHC baseline for the study.
- •7.Participant must be on stable dose(s) of guideline directed medical therapy for PAH (endothelin receptor antagonists, PDE-5 inhibitors, soluble guanylate cyclase stimulators and prostacyclin pathway analogs), consistent with American Heart Association (AHA)/American College of Cardiology (ACC)/European Society of Cardiology (ESC) or local guidelines, for at least 90 days prior to the qualifying RHC;
- •Note: Participants who take parenteral prostanoids as part of their PAH therapy will be eligible for the study until 30% (48 participants on parenteral prostanoids) have been randomized.
- •8.Females may participate if they meet one of the following criteria:
- •surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or
- •post-menopausal, as defined by: 1) Permanent cessation of menstruation for >12 months without an alternative medical cause [regardless of follicle stimulating hormone (FSH) value] at the Screening Visit, or 2) Cessation of menstruation for <12 months and FSH >40 mIU/mL at the Screening Visit.
- •All other females will be considered of childbearing potential and must either:
- •a.practice abstinence, or
排除标准
- •1.Participants with PAH associated with portal hypertension, human immunodeficiency virus (HIV), schistosomiasis or sickle cell disease as well as participants with pulmonary parenchymal disease or thromboembolic disease; historical test results that rule out parenchymal lung disease and thromboembolic disease are acceptable; if no historical results are available, pulmonary function test(s) (see exclusion criteria #4 and 5) and either a ventilation-perfusion (V/Q) scan or pulmonary angiogram must be performed during the Screening Visit;
- •2.Participants with known significant left heart disease including: left ventricular dysfunction (i.e., left ventricular ejection fraction <35%); hemodynamically compromising, symptomatic, or severe aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation;
- •3.Pulmonary hypertension belonging to WHO groups 2 to 5 (Nice, 2013);
- •4.Participants with moderate to severe obstructive lung disease defined as forced expiratory volume in 1 second (FEV1) <55% of predicted value;
- •5.Participants with moderate to severe restrictive lung disease defined as total lung capacity (TLC) <60% of predicted value;
- •6.Participants with acute decompensated heart failure or hospital admission for worsening PAH symptoms within 30 days prior to the qualifying RHC;
- •7.Participants who have received a heart or lung transplant or who are active on a transplant list;
- •8.Participants with known active liver disease or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3.0 × upper limit of normal (ULN) at the Screening Visit;
- •9.Participants with an absolute neutrophil count <1500/µL at the Screening Visit; one repeat measurement is allowed at the discretion of the Investigator;
- •10.Participants with systemic effects of an untreated active infection(s) [e.g., fever >100.4°F (38.0°C)] at Visit 2 prior to randomization;
- •Note: Successfully treated infection(s) that required antibiotics will be permitted if resolved >7 days prior to Visit 2.
- •11.Participants with a history of malignancy of any organ system (other than localized basal or squamous cell carcinoma of the skin or cervical cancer in situ), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases;
- •12.Participants with a resting systolic blood pressure <90 mmHg at the Screening Visit;
- •13.Participants with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 using the 4-variable Modification of Diet in Renal Disease (MDRD) equation:
- •eGFR (in mL/min/1.73 m2) = 175 < Serum Creatinine -1.154 x age -0.203 x 1.212 (if participant is black) X 0.742 (if female);
- •14.Participants who test positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or HIV antibodies at the Screening Visit;
- •Note: If a participant tests positive for anti-HCV antibodies, but has no history of HCV treatment, the participant may qualify for the study if the test result for HCV by polymerase chain reaction (PCR) is negative (i.e., HCV messenger ribonucleic acid [mRNA] <15 IU/mL).
- •15.Participants who are currently participating or have participated in a clinical study involving an investigational drug or device within 30 days, five half lives, or twice the duration of the biological effect of the investigational product, if known (whichever is longer) prior to the Screening Visit;
- •16.Participa
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