研究单位:[1]首都医科大学附属北京友谊医院[2]四川大学华西医院[3]浙江大学医学院附属第一医院[4]首都医科大学附属北京地坛医院[5]南京市第二医院[6]云南省第一人民医院[7]河南省人民医院[8]首都医科大学附属北京佑安医院[9]新疆医科大学第一附属医院[10]西安交通大学第一附属医院[11]福建医科大学孟超肝胆医院[12]贵州省人民医院[13]重庆医科大学附属第二医院[14]华中科技大学同济医学院附属协和医院[15]吉林大学第一医院[16]上海交通大学医学院附属仁济医院[17]中山大学附属第三人民医院[18]西京医院[19]镇江市第三人民医院[20]安徽医科大学第一附属医院[21]Buenos Aires Macula Clinical Research (BAM Clinical Research)[22]CIPREC (Centro de Investigacion y Prevencion Cardiovascular)[23]Alfred Health[24]Flinders Medical Centre[25]GI Research Institute[26]Centro Clinico Mediterraneo[27]Pontificia Universidad Católica de Chile[28]Biocinetic[29]Clinical Research Chile SpA.[30]Yonsei University Severance Hospital[31]Seoul National University Bundang Hospital[32]Kyungpook National University Hospital[33]Pusan National University Hospital[34]Marmara University Pendik Training and Research Hospital[35]Adana City Training and Research Hospital[36]Rize Recep Tayyip Erdogan University Training and Research Hospital[37]Ankara City Hospital[38]Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi[39]Ege Universitesi Tip Fakultesi[40]Mersin University Medical[41]Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital[42]Kocaeli University Hospital[43]Uludag University Medical Faculty Hosp.[44]University of Miami[45]Liver Institute Northwest[46]Henry Ford Health System[47]University of California Davis[48]Atrium Health Wake Forest Baptist[49]University of Iowa Hospitals and Clinics[50]University of Chicago[51]University of Pittsburgh School of Medicine[52]Northwell Health[53]Virginia Commonwealth University[54]University of Louisville[55]Thomas Jefferson University[56]Ochsner Clinic Foundation[57]Piedmont Healthcare (GA)[58]University of California San Francisco[59]Om Research LLC[60]MedStar Georgetown University Hospital[61]Icahn School of Medicine at Mount Sinai[62]California Pacific Medical Center[63]Tulane University[64]Cedars Sinai Medical Center[65]Covenant Research and Clinics, LLC[66]Gastroenterology Center of the MidSouth, P.C[67]Bon Secours St. Mary's Hospital of Richmond[68]University of Texas Southwestern Medical Center[69]Covenant Metabolic Specialists[70]California Liver Research Institute[71]UH Cleveland Medical Center[72]Kaiser Permanente[73]NYU Langone Hospital[74]Mercy Medical Center[75]Beth Israel Deaconess Medical Center[76]Massachusetts General Hospital[77]Liver Institute at Methodist Dallas[78]Florida Digestive Health Specialists[79]Penn State Milton S. Hershey Cancer Institute[80]Pinnacle Clinical Research, PLLC
研究目的:
目的: 评价 Seladelpar 与安慰剂相比对 EFS 的影响。EFS 定义为从治疗开始至首 次发生以下任何裁定事件(直至第 156 周)的时间: ? 任何原因导致的死亡 ? 肝移植 ? MELD 评分 ≥ 15(见附录 I) ? 需要治疗的腹水 ? 因符合以下任一条件的事件而住院治疗: i. 食管或胃静脉曲张出血 ii. 肝性脑病(定义为 West Haven 评分 ≥ 2,附录 H) iii. 自发性细菌性腹膜炎,通过诊断性腹腔穿刺获得的 WBC 计数、分类计数和/ 或需氧和/或厌氧血培养瓶出现阳性生长所证实