上海Fosmanogepix注射液III期临床试验-一项在念珠菌血症和/或侵袭性念珠菌病成人受试者中评价fosmanogepix有效性和安全性的3 期研究

登记号	CTR20252015	试验状态	进行中
申请人联系人	李绪全	首次公示信息日期	2025-05-21
申请人名称	Basilea Pharmaceutica International Ltd, Allschwil/ 精鼎医药研究开发（上海）有限公司/ Patheon Manufacturing Services LLC

登记号	CTR20252015
相关登记号	暂无
药物名称	Fosmanogepix注射液
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	用于侵袭性念珠菌病包括念珠菌血症的治疗
试验专业题目	一项fosmanogepix静脉注射（IV）跟随fosmanogepix口服治疗对照卡泊芬净静脉注射（IV）跟随氟康唑口服治疗念珠菌血症和/或侵袭性念珠菌病成人受试者的疗效和安全性3期双盲双臂的干预性研究
试验通俗题目	一项在念珠菌血症和/或侵袭性念珠菌病成人受试者中评价fosmanogepix有效性和安全性的3 期研究
试验方案编号	FMGX-CS-301	方案最新版本号	4.0
版本日期:	2024-04-09	方案是否为联合用药	否

申请人名称	[["Basilea Pharmaceutica International Ltd, Allschwil"],["精鼎医药研究开发（上海）有限公司"],["Patheon Manufacturing Services LLC"]]
联系人姓名	李绪全	联系人座机	021-62882856	联系人手机号	18601787506
联系人Email	hanson.li@psi-cro.com	联系人邮政地址	上海市-上海市-黄浦区九江路686号腾飞元创大厦第10层1002,1006室	联系人邮编	200001

本研究旨在评价fosmanogepix治疗念珠菌血症和/或侵袭性念珠菌病成人患者的有效性和安全性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["筛选时患者年龄≥18 岁（或>18 岁[国家规定的最低知情同意年龄]）并签署知情同意书，表明其理解研究目的和要求的程序，并愿意参加研究。"],["基于随机分组前≤96小时（4天）内采集的血样或非血液标本诊断为念珠菌血症和/或侵袭性念珠菌病。"],["基于患者的状况可采取适当的感染源控制措施，包括在必要时移除既存血管内导管和器械。"]]
排除标准	[["现有感染n(a)t血液或任何其他正常无菌部位出现克柔念珠菌引起的感染。n(b)t真菌感染源控制不当。n(c)t经诊断为某些深部念珠菌感染。"],["研究者认为预期寿命<72小时。"],["需要或预期需要血液透析。"],["持续存在神经系统疾病史。"],["已知患者患有人类免疫缺陷病毒感染、CD4+计数<200/mm3或病毒载量>400拷贝/mL或筛选前6个月内存在活动性机会感染。"],["可能存在增加研究参与风险或使患者不适合参与研究的其他医学或精神疾病或实验室检查异常。"],["目前使用任何禁止的合并用药或不愿意/无法使用允许的合并用药。"],["在随机分组前96小时内接受>2天（>48小时）的既往全身性抗真菌治疗，给药剂量和频率与当前念珠菌血症发作治疗相同（例如，接受>2次抗真菌药每日一次给药或>4次抗真菌药每日两次给药），不敏感念珠菌及在接受唑类药物或两性霉素B预防治疗期间发生念珠菌血症或侵袭性念珠菌病的患者除外。"],["在本研究使用的研究药物首次给药前30天内接受过试验用药品给药或试验用疫苗接种或还在其5个半衰期内（以较长者为准）。"],["既往参加过本研究或任何fosmanogepix研究。"],["中度或重度肝功能损害、活动性乙型或丙型肝炎、ALT或AST≥5×ULN或总胆红素>3×ULN，除非其由孤立性高胆红素血症或记录的吉尔伯特综合征所致。"],["女性患者处于妊娠期或哺乳期。"],["已知对fosmanogepix、manogepix、卡泊芬净、任何棘白菌素类、氟康唑或其任何辅料具有超敏反应。"],["直接参与研究实施的研究中心工作人员及其家庭成员、以其他方式受研究者监督的研究中心工作人员及直接参与研究实施的申办者和申办者代表员工及其家庭成员。"]]

试验药	[["中文通用名:Fosmanogepix片 英文通用名:Fosmanogepixtablets 商品名称:NA","剂型:片剂 规格:/ 用法用量:/ 用药时程:/"],["中文通用名:Fosmanogepix注射液 英文通用名:Fosmanogepixinjection 商品名称:NA","剂型:注射剂 规格:/ 用法用量:/ 用药时程:/"]] 序号 名称 用法
对照药	[["中文通用名:卡泊芬净注射液 英文通用名:CaspofunginInjection 商品名称:NA","剂型:注射剂 规格:70mg/瓶 用法用量:第1天给予负荷剂量70mg（每日一次），之后改为维持剂量50mg（每日一次）。 用药时程:治疗的最长持续时间为42天（卡泊芬净疗程加氟康唑疗程）。"],["中文通用名:氟康唑胶囊 英文通用名:FluconazoleCapsule 商品名称:NA","剂型:胶囊 规格:200mg 用法用量:200-800mg每日一次（由研究者决定） 用药时程:治疗的最长持续时间为42天（卡泊芬净疗程加氟康唑疗程）。"]] 序号 名称 用法

主要终点指标及评价时间

[["第30天的患者生存率","第30天","有效性指标"],["研究治疗结束（EOST）时的患者总体治疗成功率","最长至第42天","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["第14天时患者总体治疗成功率","第14天","有效性指标"],["静脉治疗结束（EOIV）时患者总体治疗成功率","最长至第42天","有效性指标"],["EOST后随访6周时患者总体治疗成功率（持续）","最长至第12.5周","有效性指标"],["第14天、EOIV、EOST和EOST后随访6周时患者的临床成功率","第14天, EOIV （最长至第42天），EOST （最长至第42天），EOST后随访6周时","有效性指标"],["第14天、EOIV、EOST和EOST后随访6周时真菌学应答为根除或推定根除的患者比例","第14天, EOIV （最长至第42天），EOST （最长至第42天），EOST后随访6周时","有效性指标"],["Fosmanogepix组与卡泊芬净/氟康唑组间患者的至首次血培养阴性时间的比较","从基线至EOST后随访6周时（总计约12.5周）","有效性指标"],["TEAE、SAE、治疗相关AE、AESI和导致治疗终止的AE发生率","从筛查期至EOST后随访6周时（总计约12.5周）","安全性指标"],["具有显著临床意义的实验室检查异常的患者人数","从基线至EOST后随访6周时（总计约12.5周）","安全性指标"],["神经系统检查异常的患者人数","从基线至EOST后随访6周时（总计约12.5周）","安全性指标"],["12导联心电图（ECG）的评估","从基线至EOST后随访6周时（总计约12.5周）","安全性指标"],["Fosmanogepix（前药）与Manogepix（活性成分）的血药浓度-时间曲线","第3天：给药后0，3，6，9和24h；n第7天、第14天、第21天、第28天、第35天；nEOST：给药后72和192h。","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王明贵	学位	医学博士	职称	教授
	电话	021-52889999	Email	mgwang@fudan.edu.cn	邮政地址	上海市-上海市-静安区乌鲁木齐中路12号
	邮编	200040	单位名称	复旦大学附属华山医院

[["复旦大学附属华山医院","王明贵","中国","上海市","上海市"],["中国医学科学院血液病医院（中国医学科学院血液学研究所）","冯四洲","中国","天津市","天津市"],["蚌埠医科大学第一附属医院","张永","中国","安徽省","蚌埠市"],["清远市人民医院","孟启勇","中国","广东省","清远市"],["中国医科大学附属盛京医院","廖爱军","中国","辽宁省","沈阳市"],["丽水市人民医院","楼天正","中国","浙江省","丽水市"],["中日友好医院","曹彬","中国","北京市","北京市"],["河南科技大学第一附属医院","张咏梅","中国","河南省","郑州市"],["浙江省人民医院","杨向红","中国","浙江省","杭州市"],["广州市第一人民医院","曾军","中国","广东省","广州市"],["浙江省中医院","江荣林","中国","浙江省","杭州市"],["上海市第十人民医院","宋小莲","中国","上海市","上海市"],["广州医科大学附属第一医院","黎毅敏","中国","广东省","广州市"],["武汉大学中南医院","彭志勇","中国","湖北省","武汉市"],["中山大学附属第一医院","管向东","中国","广东省","广州市"],["柳州市人民医院","王健琨","中国","广西壮族自治区","柳州市"],["浙江大学医学院附属邵逸夫医院","俞云松","中国","浙江省","杭州市"],["南昌大学第一附属医院","李菲","中国","江西省","南昌市"],["武汉市中心医院","汪毓君","中国","湖北省","武汉市"],["深圳市第三人民医院","卢洪洲","中国","广东省","深圳市"],["四川大学华西医院","曲俊彦","中国","四川省","成都市"],["无锡市人民医院","许红阳","中国","江苏省","无锡市"],["The Alfred Hospital","Morrissey, Orla","澳大利亚","Melbourne, VIC","Melbourne, VIC"],["Monash Medical Center Clayton","Rogers, Benjamin","澳大利亚","Clayton, VIC","Clayton, VIC"],["Saint Luc University Hospital, Department of Internal Medicine","Belkhir, Leila","比利时","Brussels","Brussels"],["Erasme Hospital, Department of Infectious and Tropical Diseases","Hites, Maya","比利时","Brussels","Brussels"],["UCL Mont-Godinne University Hospitals","Honore, Patrick","比利时","Yvoir","Yvoir"],["University Hospital Brussels","Jonckheer, Joop","比利时","Brussels","Brussels"],["General Hospital Saint-Jan","Schauwvlieghe, Alexander","比利时","Brugge","Brugge"],["Jessa Hospital","Van der Hilst, Jeroen","比利时","Hasselt","Hasselt"],["University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases","Van Wijngaerden, Eric","比利时","Leuven","Leuven"],["University Multiprofile Hospital for Active Treatment and Emergency Medicine","Argirova, Maya","保加利亚","Sofia","Sofia"],["University Multiprofile Hospital for Active Treatment and Emergency Medicine","Poromanski, Ivan","保加利亚","Sofia","Sofia"],["University Multiprofile Hospital for Active Treatment","Belev, Nikolay","保加利亚","Plovdiv","Plovdiv"],["University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases","Sprute, Rosanne","德国","Cologne, North Rhine-Westphalia","Cologne, North Rhine-Westphalia"],["University Hospital Ramon y Cajal, Department of Infectious Diseases","Fortun Abete, Jesus","西班牙","Madrid, Community of Madrid","Madrid, Community of Madrid"],["Hospital del Mar, Department of Infectious Diseases","Horcajada Gallego, Juan Pablo","西班牙","Barcelona, Catalonia","Barcelona, Catalonia"],["University Hospital Nuestra Senora de Valme","Merchante, Nicolas","西班牙","Seville, Andalusia","Seville, Andalusia"],["University Hospital Virgen Macarena","Palacios Baena, Zaira Raquel","西班牙","Seville, Andalusia","Seville, Andalusia"],["Hospital Clinic of Barcelona, Department of Infectious Diseases","Bodro, Marta","西班牙","Barcelona, Catalonia","Barcelona, Catalonia"],["Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases","Boutoille, David","法国","Nantes","Nantes"],["Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)","Dupont, Herve","法国","Amiens","Amiens"],["Tours Regional University Hospital Center","Lemaignen, Adrien","法国","Tours","Tours"],["Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit","Plantefeve, Gaetan","法国","Argenteuil","Argenteuil"],["General Hospital of Thessaloniki","Iosifidis, Elias","希腊","Thessaloniki","Thessaloniki"],["LAIKO General Hospital","Sipsas, Nikolaos","希腊","Athens","Athens"],["Tzaneio General Hospital","Chrysos, George","希腊","Piraeus","Piraeus"],["General Hospital of Athens","Papastamopoulos, Vasileios","希腊","Athens","Athens"],["Sotiria Chest Diseases Hospital of Athens","Pontikis, Konstantinos","希腊","Athens","Athens"],["The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit","Ben-Ami, Ronen","以色列","Tel-Aviv","Tel-Aviv"],["Edith Wolfson Medical Center, Department of Infectious Diseases","Maor, Yasmin","以色列","Holon","Holon"],["Shamir Medical Center, Department of Infectious Diseases","Marchaim, Dror","以色列","Tel-Aviv","Tel-Aviv"],["Rambam Health Care Campus, Institute of Infectious Diseases","Stern, Anat","以色列","Haifa","Haifa"],["Chaim Sheba Medical Center, Department of Infectious Diseases","Yahav, Dafna","以色列","Tel Hashomer","Tel Hashomer"],["Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda","Bandera, Alessandra","意大利","Milan","Milan"],["Hospital S. Croce e Carle","Del Bono, Valerio","意大利","Cuneo","Cuneo"],["University Hospital of Pisa","Falcone, Marco","意大利","Pisa","Pisa"],["Hospital San Raffaele, IRCCS","Ripa, Marco","意大利","Milan","Milan"],["Polyclinic San Matteo, IRCCS","Seminari, Elena","意大利","Pavia","Pavia"],["IRCCS Policlinic Hospital San Martino","Bassetti, Matteo","意大利","Genoa","Genoa"],["Giuliano Isontina University Health Authority","Di Bella, Stefano","意大利","Trieste","Trieste"],["Severance Hospital, Yonsei University Health System","Choi, Jun Yong","韩国","Seoul","Seoul"],["Ajou University Hospital","Choi, Young Hwa","韩国","Suwon","Suwon"],["Samsung Medical Center","Peck, Kyong Ran","韩国","Seoul","Seoul"],["Kyungpook National University Hospital","Kim, Shin Woo","韩国","Daegu","Daegu"],["Siriraj Hospital","Chayakulkeeree, Methee","泰国","Bangkok","Bangkok"],["Songklanagarind Hospital","Chusri, Sarunyou","泰国","Hat Yai","Hat Yai"],["Maharaj Nakorn Chiang Mai Hospital","Chaiwarith, Romanee","泰国","Chiang Mai","Chiang Mai"],["China Medical University Hospital","Hsueh, Po-Ren","中国台湾","Taichung","Taichung"],["Linkou Chang Gung Memorial Hospital","Huang, Po-Yen","中国台湾","Taoyuan","Taoyuan"],["Taichung Veterans General Hospital","Liu, Po-Yu","中国台湾","Taichung","Taichung"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Lu, Po-Liang","中国台湾","Kaohsiung","Kaohsiung"],["Far Eastern Memorial Hospital","Yang, Chia-Jui","中国台湾","New Taipei City","New Taipei City"],["Taipei Medical University Hospital","Wang, Fu-Der","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Lin, Yi-Tsung","中国台湾","Taipei","Taipei"],["Indiana University Methodist Hospital","Barros-Baertl, Nicolas","美国","Indianapolis, IN","Indianapolis, IN"],["The University of Texas Health Science Center at Houston, Department of Internal Medicine","Ostrosky, Luis","美国","Houston, TX","Houston, TX"],["Houston Methodist Hospital","Mylonakis, Eleftherios","美国","Houston, TX","Houston, TX"],["Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases","Alangaden, George","美国","Detroit, MI","Detroit, MI"],["UC Davis Medical Center","Crabtree, Scott","美国","Sacramento, CA","Sacramento, CA"],["University of North Carolina at Chapel Hill","Lachiewicz, Anne","美国","Chapel Hill, NC","Chapel Hill, NC"],["University of Kentucky College of Medicine","Greenberg, Richard","美国","Lexington, KY","Lexington, KY"],["Washington University School of Medicine, Infectious Diseases Clinical Research Unit","Spec, Andrej","美国","Saint Louis, MO","Saint Louis, MO"],["University of Pretoria / Steve Biko Academic Hospital","Paruk, Fathima","南非","Pretoria","Pretoria"],["Ryexo Clinical Research","Mey, Larry","南非","Pretoria","Pretoria"],["Practice of R Moodley and MI Sarvan - Umhlanga","Moodley, Rajendran","南非","Umhlanga","Umhlanga"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院血液病医院（中国医学科学院血液学研究所）伦理委员会","同意","2025-03-28"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 68 ； 国际: 450 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 12 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2024-12-11；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-12-12；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；