LY3074828注射液 预填充式注射器|进行中-招募完成

登记号
CTR20192156
相关登记号
CTR20191511,CTR20192153
曾用名
药物类型
生物制品
临床申请受理号
企业选择不公示
适应症
活动性溃疡性结肠炎
试验通俗题目
评价 LY3074828 用于活动性溃疡性结肠炎患者的维持期研究
试验专业题目
一项评价LY3074828用于中度至重度活动性溃疡性结肠炎患者的3期、多中心、随机、双盲、平行组、安慰剂对照的维持期研究
试验方案编号
I6T-MC-AMBG; 2018年3月13日
方案最近版本号
16T-MC-AMBG(12.1)
版本日期
2022-08-23
方案是否为联合用药
企业选择不公示

申请人信息

申请人名称
联系人姓名
康晓倩
联系人座机
23021428
联系人手机号
联系人Email
kang_xiao_qian@lilly.com
联系人邮政地址
上海市-上海市-上海市静安区石门一路288号香港兴业太古汇1座19楼
联系人邮编
200041

临床试验信息

试验分类
安全性和有效性
试验分期
III期
试验目的
评估完成前12周诱导研究AMAN的参与者使用LY3074828维持治疗的有效性和安全性
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至 80岁(最大年龄)
性别
男+女
健康受试者
入选标准
  • 已完成了AMAN研究,接受至少1次研究药物给药且未提前结束研究药物给药
  • 愿意且能够完成计划的研究评估,包括内镜检查和每日日志录入
  • 如果是女性,必须符合避孕要求
排除标准
  • 在此前诱导期研究AMAN期间诊断为克罗恩病或炎症性肠病 – 未分类(结肠炎)
  • 在此前诱导期研究AMAN期间接受肠切除术或其他手术来治疗UC,或在AMBG研究期间可能需要接受手术来治疗UC
  • 在研究AMAN期间存在结肠不典型增生或诊断为胃肠道癌
  • 在诱导期研究AMAN期间诊断为有临床意义的感染,包括但不限于乙型肝炎、丙型肝炎、HIV/AIDS和活动性结核(TB)
  • 在诱导期研究AMAN期间开始新的禁止使用的药物治疗
  • 在开始AMBG研究之前存在某些实验室异常,且需要永久终止研究药物治疗

试验分组

试验药
名称 用法
中文通用名:LY3074828注射液 预填充式注射器
用法用量:注射液,规格100mg/ml,皮下给药;对于应答组患者,每四周一次200mg皮下注射,用药时程最长40周,在12-28周之间,如确认患者失去应答,则给予每四周一次LY3074828 300 mg输注给药12周,对于非应答组患者将接受开放标签LY3074828每四周一次 300 mg输注给药12周,如果患者应答将继续给予患者LY3074828 每四周一次200mg皮下给药28周,如不应答则退出试验
中文通用名:LY3074828注射液 小瓶
用法用量:注射液,规格20mg/ml,输注给药;对于应答组患者,每四周一次200mg皮下注射,用药时程最长40周,在12-28周之间,如确认患者失去应答,则给予每四周一次LY3074828 300 mg输注给药12周,对于非应答组患者将接受开放标签LY3074828每四周一次 300 mg输注给药12周,如果患者应答将继续给予患者LY3074828 每四周一次200mg皮下给药28周,如不应答则退出试验
对照药
名称 用法
中文通用名:外形与LY3074828注射液相同的安慰剂 预填充式注射器
用法用量:注射液,规格100mg/ml,皮下给药;对于应答组患者,每四周一次200mg皮下注射,用药时程最长40周,在12-28周之间,如确认患者失去应答,则给予每四周一次LY3074828 300 mg输注给药12周,对于非应答组患者将接受开放标签LY3074828每四周一次 300 mg输注给药12周,如果患者应答将继续给予患者LY3074828 每四周一次200mg皮下给药28周,如不应答则退出试验
中文通用名:外形与LY3074828注射液相同的安慰剂 预填充式注射器
剂型:注射液

终点指标

主要终点指标
指标 评价时间 终点指标选择
临床缓解状态的患者比例,临床缓解基于改良的Mayo评分(MMS) 第40周 有效性指标+安全性指标
次要终点指标
指标 评价时间 终点指标选择
企业选择不公示
数据安全监察委员会(DMC)
为受试者购买试验伤害保险

研究者信息

姓名 学位 职称 电话 Email 邮政地址 邮编 单位名称
冉志华 博士 教授 021-58752345 zhihuaran@vip.163.com 上海市-上海市-上海市东方路1630号 200127 上海交通大学医学院附属仁济医院
沈骏 博士 主任医师 021-58752345 shenjun@vip.163.com 上海市-上海市-上海市东方路1630号 200127 上海交通大学医学院附属仁济医院

各参加机构信息

机构名称 (主要)研究者 国家 地区 城市
上海交通大学医学院附属仁济医院 冉志华 中国 上海市 上海市
上海交通大学医学院附属仁济医院 沈骏 中国 上海市 上海市
浙江大学医学院附属邵逸夫医院 曹倩 中国 浙江 杭州
中山大学附属第六医院 高翔 中国 广东 广州
华中科技大学同济医学院附属同济医院 刘梅 中国 湖北 武汉
江苏省人民医院 张国新 中国 江苏 南京
上海交通大学医学院附属瑞金医院 钟捷 中国 上海 上海
安徽省立医院 张开光 中国 安徽 合肥
中南大学湘雅医院 徐美华 中国 湖南 长沙
温州医科大学第二附属医院 蒋益 中国 浙江 温州
陆军军医大学第二附属医院 郭红 中国 重庆 重庆
山东大学齐鲁医院 李延青 中国 山东 济南
聊城市人民医院 焉鹏 中国 山东 聊城
昆明医科大学第一附属医院 张海蓉 中国 云南 昆明
浙江大学医学院附属第二医院 陈焰 中国 浙江 杭州
东南大学附属中大医院 施瑞华 中国 江苏 南京
安徽医科大学第一附属医院 胡乃中 中国 安徽 合肥
陆军军医大学第一附属医院(重庆西南医院) 陈磊 中国 重庆 重庆
华中科技大学同济医学院附属协和医院 侯晓华 中国 湖北 武汉
南京鼓楼医院 邹晓平 中国 江苏 南京
云南省第一人民医院 宋正己 中国 云南 昆明
海南省人民医院 蓝程 中国 海南 海口
江西萍乡市人民医院 李兴 中国 江西 萍乡
浙江大学第一附属医院 陈春晓 中国 浙江 杭州
南京市江宁医院 王建宁 中国 江苏 南京
吉林市中心医院 王东明 中国 吉林省 吉林市
四川大学华西医院 王玉芳 中国 四川省 成都市
武汉大学人民医院 丁一娟 中国 湖北省 武汉市
常州市第二人民医院 刘文佳 中国 江苏省 常州市
泰安市中心医院 王庆才 中国 山东省 泰安市
株洲市中心医院 吴达军 中国 湖南省 株洲市
青岛大学附属医院 丁雪丽 中国 山东省 青岛市
山东省立医院(东院区) 刘吉勇 中国 山东省 济南市
南昌大学第一附属医院 陈幼祥 中国 江西省 南昌市
福建医科大学附属第一医院 王承党 中国 福建省 福州市
郑州大学第二附属医院 冯百岁 中国 河南省 郑州市
河北医科大学第二医院 张晓岚 中国 河北省 石家庄市
山东省立医院(中心院区) 刘吉勇 中国 山东省 济南市
中国医科大学附属盛京医院滑翔院区 郑长清 中国 辽宁省 沈阳市
Universit?tsklinikum Salzburg Sonja Gassner Austria Salzburg Salzburg
Medical University of Vienna Walter Reinisch Austria Vienna Vienna
Medizinische Universit?t Innsbruck Robert Koch Austria Tyrol Innsbruck
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Marc Ferrante Belgium Flemish Brabant Leuven
AZ Klina Jos Callens Belgium Antwerp Brasschaat
Universitair Ziekenhuis Gent Pieter Hindryckx Belgium East Flanders Gent Oost-Vlaanderen
Centre Hospitalier de Wallonie Souhail Saikali Belgium Hainaut Tournai
ISCARE Clinical Centre Milan Lukas Czech Republic Praha Praha
Hepato-gastroenterologie HK, s.r.o. Miroslava Volfova Czech Republic Královéhradecky Hradec Kralove
PreventaMed, s.r.o. Jiri Pumprla Czech Republic Olomoucky Olomouc
Fakultni nemocnice Kralovske Vinohrady Zdena Zadorova Czech Republic Praha Praha
Mediendo s.r.o. Stepan Suchanek Czech Republic Praha Praha
A-Shine s.r.o. Lubos Janu Czech Republic Plzeňsky Plzen
Fakultni nemocnice u sv. Anny v Brne Jan Ulbrych Czech Republic South Moravian Brno
Gregar s.r.o. Jan Gregar Czech Republic Olomoucky Olomouc
Vojenska nemocnice Brno Tomas Brabec Czech Republic South Moravian Brno
Zealand University Hospital K?ge Signe Wildt Denmark Sj?lland K?ge
Herlev and Gentofte Hospital Jakob Seidelin Denmark Hovedstaden Herlev
Hopital de Hautepierre - Service d’Hépatogastroentérolgie Jean-Marie Reimund France Strasbourg Cedex Bas Rhin Strasbourg Cedex Bas Rhin
Hopital Saint Eloi Romain Altwegg France Hérault Montpellier
CHU Tours - H?pital Trousseau Laurence Picon France Indre-et-Loire Chambray les Tours
Hopital Saint-Louis Matthieu Allez France Paris Cedex Paris Cedex
Hopital Beaujon Xavier Treton France Hauts-de-Seine Clichy
CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro Mathurin Fumery France Somme Amiens Cedex
CHU de Saint Etienne Hopital Nord Avenue Albert Raimond Xavier Roblin France Loire Saint Priest en Jarez France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Stephane Nancey France Pierre Benite cedex Rhone Pierre Benite cedex Rhone
Centre Hospitalier de Pau 4 BD Hauterive Mireille Simon France Pau CEDEX Pau CEDEX
ROBERT DEBRE HOSPITAL AVENUE DU GENERAL Guilllaume Cadiot France REIMS REIMS
Hopital L'Archet 2 Xavier Hebuterne France Nice Cedex Nice Cedex
CHU Lille - H?pital Claude Huriez Pierre Desreumaux France Lille cedex Nord Lille cedex Nord
CHRU Nancy Brabois - H?pital d'Enfants Laurent Peyrin-Biroulet France Vandoeuvre les Nancy Vandoeuvre les Nancy
Hopital Nord de Marseille Jean-Charles Grimaud France Marseille Cedex Marseille Cedex
CHU Bordeaux - H?pital Haut-Lévêque David Laharie France Pessac Cedex Pessac Cedex
INLUGA im Haus der Gesundheit Peter Uebel Germany Rhineland-Palatinate Ludwigshafen
Krankenhaus Waldfriede e. V. Carsten Buening Germany Berlin Berlin
Staedisches Klinikum Brandenburg Stefan Lueth Germany Brandenburg Brandenburg
Internistische Praxisgemeinschaft Vassilios Kardalinos Germany Lower Saxony Weyhe
Medizinische Hochschule Hanover Abt. Gastroenterologie, Geb?ude Ursula Seidler Germany Niedersachsen Hannover Niedersachsen
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt Lars Fechner Germany Sachsen-Anhalt Halle (Saale)
Martin-Luther-Universit?t Halle-Wittenberg Jens Walldorf Germany Sachsen-Anhalt Halle (Saale)
Charité Universit?tsmedizin Berlin Campus Buch Britta Siegmund Germany Berlin Berlin Berlin Berlin
Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen Stefanie Howaldt Germany Hamburg Hamburg
Endomedix Diagnosztikai Kozpont Tunde Kristof Hungary Borsod-Abaúj-Zemplén Miskolc
Semmelweis Egyetem II.sz. Belgyogyaszati Klinika Zsolt Tulassay Hungary Budapest Budapest
Clinfan Szolgaltato Kft. Agnes Salamon Hungary Tolna megye Szekszard
Obudai Egeszsegugyi Centrum Kft Csaba Fulop Hungary Budapest Budapest
Debreceni Egyetem Klinikai Kozpont Istvan Altorjay Hungary Hajdú-Bihar Debrecen
DRC Gyogyszervizsgalo Kozpont Kft. Laszlo Koranyi Hungary Veszprém Balatonfüred EU
Karolina Korhaz-Rendelointezet Gyula Pecsi Hungary Gy?r-Moson-Sopron megye Mosonmagyarovar
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika Tamas Molnar Hungary Csongrád-Csanád megye Szeged
Javorszky Odon Hospital Tibor Szaloki Hungary Pest megye Vac
Beaumont Hospital Aoibhlinn O'Toole Ireland Dublin Dublin
Presidio di Rho Simone Saibeni Italy Milan Rho Milano
Azienda Ospedaliero Universitaria San Martino Maria Caterina Parodi Italy Liguria Genova Genova
Azienda Ospedaliera Universitaria Pisana Santino Marchi Italy Tuscany Pisa
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Giovanni Monteleone Italy Milan San Donato Milanese
Istituto Clinico Humanitas Silvio Danese Italy Milan Rozzano Milano
Policlinico Univ. Agostino Gemelli Antonio Gasbarrini Italy Lombardy Roma
I.R.C.C.S Policlinico San Donato Luca Pastorelli Italy Milan Donato Milanese
Gastroenterology and Endoscopy Unit IRCCS Ca’ Granda Ospedale Maggiore Policlinico Foundation Maurizio Vecchi Italy Lombardy Milano
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia Marco Marino Italy Friuli-Venezia Giulia Udine
Azienda ospedaliero-universitaria Mater Domini Francesco Luzza Italy Catanzaro Catanzaro
Ospedale Mauriziano Umberto I Marco Daperno Italy Piedmont Torino
Ospedale Sandro Pertini Roberta Pica Italy Lazio Roma
Azienda Ospedaliera Universitaria Policlinico de Modena Erica Villa Italy Emilia-Romagna Modena
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Chiara Ricci Italy Lombardy Brescia
Digestive Diseases Center Ivars Tolmanis Latvia Riga Riga
Pauls Stradins Kliniska Universitates Slimnica Juris Pokrotnieks Latvia Riga Riga
Riga Eastern Clinical University Hospital Ateksejs Derovs Latvia Riga Riga
Republic Hospital of Klaipeda Arunas Kancauskas Lithuania Klaipeda Klaipeda
Klaipeda Seamen's Hospital Giedrius Simulionis Lithuania Klaipeda Klaipeda
Vilnius University Hospital Santariskiu Clinics Ieva Stundiene Lithuania Vilnius Vilnius
Respublikine Panevezio Ligonine Darius Kriukas Lithuania Panevezys Panevezys
Hospital of Lithuanian University of Health Sciences Kaunas Gediminas Kiudelis Lithuania Kaunas Kaunas
St Elisabeth Ziekenhuis Robert Laheij Netherlands Brabant Tilburg
Bernhoven Ziekenhuis Researchbureau MDL Ingrid Gisbertz Netherlands Brabant Uden
UMC Utrecht, Dept. of Internal Medicine, MDL Herma Fidder Netherlands Utrecht Heidelberglaan
Academisch Medisch Centrum Mark Lowenberg Netherlands North Holland Alkmaar Zaanstreek
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED Anna Wiechowska-Kozlowska Poland Pomeranian Szczecin
PlanetMed Sp.z o.o. Barbara Wozniak-Stolarska Poland Lower Silesian Wroclaw
Samodzielny Publiczny Szpital Kliniczny nr 4 Cichoz-Lach Halina Poland Lublin Lublin
Centrum Zdrowia Matki, Dziecka i M?odzie?y (CZMDM) Przychodnie Michal Lawinski Poland Mazovia Warszawa
Twoja Przychodnia-Szczecinskie Centrum Medyczne Beata Gawdis-Wojnarska Poland West Pomeranian Szczecin
NZOZ ALL-MEDICUS, Zaklad Gastroenterologii Aldona Mularczyk Poland Silesian Katowice
PROMEDICA S.C Lukasz Firkowski Poland Silesian Bedzin
KO-MED Centra Kliniczne Staszow Jacek Kieltucki Poland ?wi?tokrzyskie Staszow
Centrum Medyczne NeuroProtect Maciej Gonciarz Poland Masovian Warszawa
Wojewodzki Specjalistyczny Szpital w Olsztynie Tomasz Arlukowicz Poland Warmian-Masurian Olsztyn
ETG Zamosc Katarzyna Wojcik Poland Lublin Zamosc
GASTROMED KOPO? ZMUDZI?SKI I WSPóLNICY SPó?KA JAWNA SPECJALISTYCZNE CENTRUM GASTROLOGII I ENDOSKOPII Marcin Zmudzinski Poland Kuyavian-Pomeranian Torun
Topolowa Medicenter Zbigniew Wylegala Poland Lesser Poland Krakow
NZOZ FORMED Beata Mroziak Poland Lesser Poland Wadowice
Medicenter Nowy Targ Przemyslaw Zycinski Poland Lesser Poland Nowy Targ
Warsaw IBD Point Profesor Kierkus Jaroslaw Kierkus Poland Masovian Warszawa
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej Maria Klopocka Poland Kuyavian-Pomeranian Bydgoszcz
Vivamed Robert Petryka Poland Masovian Warszawa
LexMedica Osrodek Badan Klinicznych Jerzy Rozciecha Poland Lower Silesian Wroclaw
GASTROMED Zak?ad Opieki Zdrowotnej Wit Danilkiewicz Poland Lublin Lublin
Hifu Terramed Conformal SRL Theodor-Alexandru Voiosu Romania Ilfov Bucuresti
CCBR Clinical Research Daniela Bartos Romania Ilfov Bucuresti
MedLife Grivita Ion-Eugeniu Craciun Romania Ilfov Bucuresti
Spitalul Clinic Colentina Radu Mateescu Romania Ilfov Bucuresti
Spital Pelican Oradea Alin-Horea Suta Romania Bihor Oradea
Institutul Clinic Fundeni George Stancu Romania Ilfov Bucuresti
Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica Jozef Balaz Slovakia Banska Bystrica
Gastro I s.r.o., Gastroenterologická ambulancia Ivan Bunganic Slovakia Pre?ov Pre?ov
Endomed, s.r.o.- Gastroenterologicka ambulancia Miroslav Fedurco Slovakia Pre?ov Vranov n. Toplou
KM Management spol. s r.o. Gastroenterologicke a hepatologicke centrum Milos Gregus Slovakia Nitra Nitra
Univerzitna nemocnica Bratislava Cliniq s.r.o. Gastroenterologicka ambulancia Tibor Hlavaty Slovakia Bratislava Bratislava
Hospital Universitari de Girona Xavier Aldeguer Mante Spain Girona Girona
Hospital Universitario Marques De Valdecilla Javier Crespo Garcia Spain Cantabria Santander
Hospital General Juan Ramón Jiménez Juan Maria Vazquez Moron Spain HUELVA HUELVA
Complexo Hospitalario Universitario A Coru?a, CHUAC Maria Teresa Diz-Lois Palomares Spain La Coru?a La Coru?a
Hospital De Fuenlabrada Fernando Bermejo San Jose Spain Madrid Fuenlabrada
INSTITUTO DE CIENCIAS MéDICAS Luis De Teresa Parreno Spain Valencian Alicante
Hospital Universitario La Paz Unidad de Enfermedad Maria Dolores Martin Arranz Spain Madrid Madrid
Hospital de Sagunto Xavier Cortes Rizo Spain Valencia Port de Sagunto
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO Eduardo Leo Carnerero Spain Andalucía Sevilla
Hospital Universitario Central de Asturias Sabino Riestra Menendez Spain Asturias Oviedo
Hospital De Gran Canaria Dr. Negrin Daniel Ceballos Santos Spain Canary Las Palmas de Gran Canaria
Hospital Universitari Son Espases Daniel Ginard Vicens Spain Balearic Palma de Mallorca
Universit?tsspital Zürich USZ Zürich Luc Biedermann Switzerland Zürich Zürich
Kantonsspital St.Gallen Studienabteilung Gastroenterologie Stephan Brand Switzerland St. Gallen St.Gallen
Inselspital Bern Pascal Juillerat Switzerland Bern Bern
Praxis Balsiger, Seibold & Partner und Crohn-Colitis-Zentrum Frank Seibold Switzerland Bern Bern
Fairfield General Hospital Jimmy Limdi United Kingdom Lancashire Bury
St James's University Hospital Leeds Cardiovascular and Metabolic Medicine (LICAMM) Christian Selinger United Kingdom West Yorkshire Leeds
Morriston Hospital Mesbah Rahman United Kingdom Swansea Swansea
Queens Hospital Leena Sinha United Kingdom Essex Romford
St Thomas' Hospital Peter Irving United Kingdom London London
Whipps Cross University Hospital Syed Hoque United Kingdom London London
Hopital Maisonneure-Rosemount Guy Aumais Canada Quebec Montreal
Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC Waqqas Afif Canada Quebec Montreal
University of Western Ontario Vipul Jairath Canada Ontario London
Allen Whey Khye Lim Professional Corporation Allen Lim Canada Alberta Edmonton
The Gordon and Leslie Diamond Health Care Centre Baljinder Salh Canada British Columbia Vancouver
Victoria Hospital Terry Ponich Canada ONTARIO LONDON
GI Research Institute Gregory Rosenfeld Canada British Columbia Vancouver
PerCuro Clinical Research Ltd. Dustin Loomes Canada British Columbia Victoria
Centre de santé et de services sociaux Champlain-Charles-Le Moyne Etienne Desilets Canada Park Quebec Greenfield
Texas Digestive Disease Consultants Timothy Ritter United States Ontario Southlake
Minnesota Gastroenterology, P.A. Daniel Van Handel United States Devon Plymouth
Maricopa Integrated Health System Keng-Yu Chuang United States Arizona Phoenix
Digestive Disease Associates, Ltd. Nirav Shah United States Pennsylvania Wyomissing
Wellness Clinical Research Lucky Flores United States Florida Hialeah
Clinical Research Institute of Michigan, LLC Ronald Fogel United States Michigan Chesterfield
Digestive Healthcare of Georgia Michael Galambos United States Georgia Atlanta
Emeritas Research Group Satinder Gill United States Virginia Leesburg
Digestive Health Associates of Texas Harry Sarles United States Texas Garland
Carolina Digestive Diseases Phillip Goldstein United States North Carolina Greenville
Northwell Health Keith Sultan United States New York Great Neck
Paramount Medical Research Mazen Issa United States Ohio Middleburg Heights
Weill Cornell Medical College Ellen Scherl United States New York New York
Gastro One Ziad Younes United States Tennessee Germantown
Huron Gastroenterology Associates Najm Soofi United States Michigan Ypsilanti MI
Biopharma Informatic, LLC James Maher United States Texas Houston
University of Oklahoma Health Sciences Center Richard Harty United States Oklahoma Oklahoma City
Research Associates of South Florida, LLC Javier Sobrado United States Florida Miami
Carilion Clinic Gastroenterology Maithili Chitnavis United States Virginia Roanoke
Henry Ford Health System Gastroenterology/Hepatology Nirmal Kaur United States Michigan Novi
Grand Teton Research Group, PLLC Clint Behrend United States Idaho Idaho Falls
UCSF Medical Center at Mission Bay Melvin Heyman United States California San Francisco
Southern Star Research Institute, LLC Jeff Bullock United States Texas San Antonio
Nola Research Works, LLC Vivek Huilgol United States Louisiana New Orleans
Midwest Medical Care Chandar Singaram United States South Dakota Sioux Falls
California Medical Research Group Calin Arimie United States California Northridge
DCR-PI, PC Connie Hsu United States Arizona Litchfield Park
Care Access Research Mark Kogan United States California Berkeley
Gastroenterology Research of San Antonio Nicholas Martinez United States Texas San Antonio
Nature Coast Clinical Research, LLC Paul Hellstern United States Florida Inverness
Central Sooner Research Robert Gordon United States Oklahoma Norman
Gastroenterology Associates of Pensacola, PA Frederic Newman United States Florida Pensacola
Indiana University School of Medicine Sashidhar Sagi United States Indiana Indianapolis
Wisconsin Center for Advanced Research Brian Moloney United States Wisconsin Milwaukee
University of North Carolina Animesh Jain United States North Carolina Chapel Hill
Digestive Health Specialists of the Southeast Paul Lamb United States Alabama Dothan
Florida Hospital Udayakumar Navaneethan United States Florida Orlando
Clinical Applications Laboratories, Inc Vijayalakshmi Pratha United States California San Diego
Om Research, LLC Jatinder Pruthi United States California Lancaster
Cotton-O'Neil Clinical Research Center, Digestive Health Curtis Baum United States Kansas Topeka
Gastroenterology Associates of Western Michigan, P.L.C. Allan Coates United States Michigan Wyoming
NorthShore University HealthSystem Eugene Yen United States Illinois Evanston
Physicians Research Group Doo-Sang Cho United States Arizona Tempe
Care Access Research LLC - Salt Lake City Chad Gonzales United States Utah Ogden
Care Access Research LLC Glenn Freed United States Pennsylvania Pottsville
Texas Digestive Disease Consultants Timothy Ritter United States Texas Southlake
Care Access Research - Youngstown Sayed Yossef United States Ohio Poland OH
Texas Digestive Disease Consultants Jonathon Chapman United States Louisiana Baton Rouge
Valley Gastroenterology Cnslts Elias Tarakji United States California Arcadia
Houston Methodist Research Ins Bincy Abraham United States Texas Houston
The Gasteroenterology Group, PC Emil Valle United States Virginia Reston
Florida Medical Clinic LLC Mark Eisner United States Florida Zephyrhills
SIH Research, LLC Syed Mumtaz United States Florida Kissimmee
Clintheory Healthcare Souheil Moussly United States Florida Orlando
Galen Medical Group Colleen Schmitt United States Tennessee Hixson
Direct Helpers Medical Center Manuel Fernandez United States Florida Hialeah
Digestive Health Specialists William Holderman United States Washington Tacoma
Delta Research Partners LLC Bal Raj Bhandari United States Louisiana Monroe
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas Emiliano Tron Argentina Buenos Buenos
CER Instituto Medico Edgardo Gimenez Argentina Buenos Quilmes
Hospital Privado Centro Medico de Cordoba SA Domingo Balderramo Argentina Cordoba Cordoba
Fundación de Estudios Clínicos Camilo Azum Argentina Santa Fe Rosario
Centro de Investigaciones Metabólicas (CINME) Estanislao Gomez Argentina CABA Buenos Aires CABA Buenos Aires
Sanatorio 9 de Julio SA Abel Novillo Argentina Tucuman San Miguel de Tucuman
Centro de Investigaciones Médica Tucumán Eduardo Ezequiel Martinez Argentina Tucumán SAN M. DE TUCUMAN
Coastal Digestive Health Hans Seltenreich Australia Queensland Maroochydore
Royal Adelaide Hospital Peter Bampton Australia South Australia Adelaide
The Alfred Hospital Miles Sparrow Australia Victoria Melbourne
The Royal Melbourne Hospital Colorectal Medicine & Genetics, Finlay Macrae Australia Victoria Parkville
Box Hill Hospital Olga Niewiadomski Australia Victoria Box Hill
Princess Alexandra Hospital Gerald Holtmann Australia Queensland Brisbane
Mater University Hospital Jakob Begun Australia Queensland South Brisbane
M S Ramaiah Medical College Hospital Avinash Balekuduru India Karnataka Bangalore
Fortis Hospital Ajay Bhalla India Uttar Pradesh Noida
Apollo Research and Innovations, Apollo Hospitals International Ltd Shravan Bohra India Gujarat Gandhinagar
King George Medical University Abhijit Chandra India Uttar Pradesh Lucknow
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre Mohammed Aejaz Habeeb India Andhra Pradesh Hyderabad
Bangalore Medical College and Research Institute Parvesh Kumar Jain India Karnataka Bangalore
S.R. Kalla Hospital Mukesh Kalla India Rajasthan Jaipur
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital Vijendra Kirnake India Maharashtra Wardha
Escorts Heart Institute and Research Centre Ltd Ajay Kumar India Delhi New Delhi
Shree Giriraj Hospital Chetan Mehta India Gujarat Rajkot
Midas Multispecilaity Hopsital Pvt Ltd Shrikant Mukewar India Nagpur Ramdaspeth
Poona Medical Foundation. Ruby Hall Clinic Nitin Pai India Maharashtra Pune
Nirmal Hospital Private Limited Saumin Shah India Gujarat Surat
Dayanand Medical College Ajit Sood India Punjab Ludhiana
Gandhi Hospital Shravan Porika India Telangana Secunderabad
Soroka Medical Center - Pediatric Outpatient Clinic Arik Segal Israel Beer-Sheva Beer-Sheva
Tel Aviv Sourasky Medical Center Sigal Fishman Israel Tel Aviv Tel Aviv
Assaf Harofeh Medical Center Haim Shirin Israel Zerifin Zerifin
Galilee Medical Center Department of Internal Medicine A Assy Nimer Israel Haifa Nahariya
Shaare Zedek Medical Center Eran Goldin Israel Jerusalem Bait Vagan Jerusalem
Kaplan Medical Center Ehud Melzer Israel Rehovot Rehovot
Kumagaya General Hospital Takeshi Ishikawa Japan Saitama-Ken Kumagaya-shi
Takagi Clinic Sho Takagi Japan Miyagi-Ken Sendai-shi
Kitakyushu Municipal Medical Center Hirotada Akiho Japan Fukoka Kitakyusyu-shi
Tokushukai Sapporo Higashi Tokushukai Hospital Atsuo Maemoto Japan Hokkaido Sapporo-shi
Juntendo University Hospital Tomoyoshi Shibuya Japan Tokyo Bunkyo-ku
Aichi Medical University Hospital Makoto Sasaki Japan Aichi-ken Nagakute-shi
Tokushukai Sapporo Tokushukai Hospital Toshifumi Ashida Japan Hokkaido Sapporo-shi
Kagawa Prefectural Central Hospital Tomoki Inaba Japan Kagawa Takamatsu
NHO Mito Medical Center Hiroyasu Ishida Japan HigaShiibaraki-Gun Ibaraki-machi
Ishida Clinic of IBD and Gastroenterology Tetsuya Ishida Japan Oita-Ken Oita-shi
NHO Hirosaki National Hospital Yo Ishiguro Japan Aomori-Ken Hirosaki-shi
Fukuoka University Chikushi Hospital Takashi Hisabe Japan Fukuoka-Ken Chikushino-shi
Kitasato University Kitasato Institute Hospital Masaru Nakano Japan Tokyo Minato-Ku
Okayama University Hospital Sakiko Hiraoka Japan Okayama Okayama
Fujita Health University Hospital Naoki Ohmiya Japan Aichi-ken Toyoake-shi
Shinseikai Sai Gastroenterology, proctology Souken Sai Japan Osaka Fu Fujiidera-shi
NHO Kyoto Medical Center Shinji Katsushima Japan Kyoto Kyoto-shi
NHO Osaka National Hospital Hisashi Ishida Japan Osaka Osaka-shi
Center Hospital of the National Center for Global Health and Medicine Junichi Akiyama Japan Tokyo-To Shinjuku-ku
Sankikai Yokohama Shin midori General Hospital Nobutsuna Kuwamoto Japan Kanagawa-Ken Yokohama-shi
Fukuoka University Hospital Fumihito Hirai Japan Fukuoka Fukuoka
Matsuaikai Matsuda Hospital Kazuhiko Kawakami Japan Shizuoka-Ken Hamamatsu-shi
Tokitokai Tokito Clinic Satoki Tokito Japan Saitama-Ken Saitama-shi
Showa University Koto Toyosu Hospital Naoyuki Uragami Japan Tokyo Koto-ku
Nagaoka Chuo General Hospital Takashi Tomidokoro Japan Niigata Nagaoka-shi
Aoyama Clinic GI Endoscopy & IBD Center Nobuo Aoyama Japan Hyogo-Ken Kobe-shi
Hiroshima University Hospital Shinji Tanaka Japan Hiroshima-ken Hiroshima-shi
Yokohama City University Medical Center Reiko Kunisaki Japan Kanagawa Yokohama
Hidaka Coloproctology Clinic Hisamitsu Hidaka Japan Fukuoka-Ken Kurume-shi
Jichi Medical University Hospital Keijiro Sunada Japan Tochigi-Ken Shimotsuke-shi
Showa University Northern Yokohama Hospital Noriyuki Ogata Japan Kanagawa Yokohama
Gunma University Hosptial Toshio Uraoka Japan Gunma Maebashi
Kumamoto University Hospital Hideaki Naoe Japan Kumamoto Kumamoto-shi
Mitsui Memorial Hospital Nobuo Toda Japan Tokyo-To Chiyoda-ku
Asahikawa City Hospital Masaki Taruishi Japan Hokkaido Asahikawa
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital Satoshi Motoya Japan Hokkaido Sapporo-shi
Saga-Ken Medical Center Koseikan Shinichi Ogata Japan Saga-Ken Saga-Shi
Toho University School of Medicine, Sakura Hospital Katsuyoshi Matsuoka Japan Chiba Sakura
Tokyo Medical And Dental University Medical Hospital Toshimitsu Fujii Japan Tokyo Bunkyō
JHCO Tokyo Yamate Medical Center Naoki Yoshimura Japan Tokyo Shinjuku-ku
Kinshukai Infusion Clinic Hiroaki Ito Japan Osaka-fu Osaka-City
Kyorin University Hospital Tadakazu Hisamatsu Japan Tokyo Mitaka
Gokeikai Ofuna Chuo Hospital Yutaka Endo Japan Kanagawa Kamakura-shi
Toyama Prefectural Central Hospital Koichiro Matsuda Japan Toyama Toyama-Shi
Mie University Hospital Noriyuki Horiki Japan Mie Tsu
Sameshima Hospital Yukinori Sameshima Japan Kagoshima Kagoshima-shi
Takasaki General Medical Center Tomohiro Kudo Japan Gunma Takasaki
Kawasaki Municipal Kawasaki Hospital Hanae Takagi Japan Kanagawa Kawasaki
Dong-A University Hospital Jonghun Lee Korea, South Busan Pusan Kwangyǒkshi
Kangbuk Samsung Hospital Dong II Park Korea, South Seoul Seoul-teukbyeolsi
Asan Medical Center Sang Hyoung Park Korea, South Seoul Korea Songpa-Gu
Samsung Medical Center YoungHo Kim Korea, South Seoul Seoul-teukbyeolsi
Severance Hospital Hyun-Soo Kim Korea, South Wonju-si Gangwon-do
Kyung Hee University Hospital Hyo-Jong Kim Korea, South Seoul Korea Dongdaemun-gu Seoul Korea
Inje University Haeundae Paik Hospital Tae-oh Kim Korea, South Busan Busan
The Catholic University of Daejeon St. Mary's Hospital Sang Bum Kang Korea, South Daejeon Daejeon
Yeungnam Univeristy Medical Center ByungIk Jang Korea, South Daegu Daegu
University Malaya Medical Centre Ida Normiha Hilmi Malaysia Kuala Lumpur Lembah Pantai
Hospital Ampang Rosaida Hj Md Said Malaysia Selangor Ampang
Universiti Sains Malaysia Yeong Yeh Lee Malaysia Kelantan Kubang Kerian
Centro de Investigación Clínica Acelerada Emilio Fernando Bermudez Villegas Mexico Mexico City Distrito Federal Mexico City Distrito Federal
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. Roberto Cruz Neri Mexico Jalisco Zapopan
Sociedad de Metabolismo y Corazon S.C. Aracely Cruz Palacios Mexico Veracruz Veracruz
Centro Para el Desarrollo de la Medicina y de Asistencia Med Victor Efren Gallardo Angulo Mexico Sinaloa Culiacan
Scientia Investigacion Clinica S.C. Gaspar Iglesias Miramontes Mexico Chihuahua Chihuahua
LLC Scientific Research Centre EKO-Bezopasnost Konstantin Zakharov Russian Federation Saint Petersburg Saint Petersburg
Yaroslavl Municipal HI Clinical Hospital #8 Andrey Arshinov Russian Federation Yaroslavl Yaroslavl
Saint Petersburg State Medical University n.a. Pavlov I.P. Vasiliy Trofimov Russian Federation Saint Petersburg Saint Petersburg
Clinical Diagnostic Center Ultramed Valentina Molostova Russian Federation Omsk Omsk
Pokrovskaya Municipal Hospital Igor Bakulin Russian Federation Saint-Petersburg Saint-Petersburg
Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod Natalia Eremina Russian Federation Volga Federal Nizhniy Novgorod
Karelia Republican Hospital V.A. Baranova Olga Barysheva Russian Federation Petrozavodsk Petrozavodsk
City Mariinskaya Hospital Natalia Gonchar Russian Federation St. Petersburg St. Petersburg
Medical rehabilitation center Nikitin Igor Russian Federation Moscow Moscow
Non-state Healthcare Institution Viktor Shunkov Russian Federation Saint-Petersburg Saint-Petersburg
State Autonomous Institution of Healthcare Rustem Abdulkhakov Russian Federation Kazan Kazan
Medical Institute REAVIZ Elena Bunkova Russian Federation Samara Samara
Clinical Trials Center of Medical Institute Vladimir Rafalskiy Russian Federation Kaliningrad Kaliningrad
SIH Kemerovo Regional Clinical Hosptial Irina Khodareva Russian Federation Kemerovo Kemerovo
Multidisciplinary Medical Clinic Galina Chumakova Russian Federation Barnaul Barnaul
SBIH City Clinical Hospital #31 Oksana Shchukina Russian Federation Saint-Petersburg Saint-Petersburg
LLC MA New Hospital Denis Nikolin Russian Federation Ekaterinburg Ekaterinburg
Medical and Sanitary Division of Severstal Denis Medvedev Russian Federation Cherepovets Cherepovets
Stavropol State Medical Academy Vladimir Pavlenko Russian Federation Stavropol Stavropol
Irkutsk State Medical Academy of Continuing Education Olga Fedorishina Russian Federation Irkutsk Irkutsk
Rostov State Medical University Alexey Yakovlev Russian Federation Rostov-on-Don Rostov-on-Don
LLC “Medicine Center SibNovoMed Marina Osipenko Russian Federation Novosibirsk Novosibirsk
Nizhegorodskiy Regional Clinical Hospital N.A.Semashko Olga Alexeeva Russian Federation Novgorod Novgorod
LLC Alliance Biomedical - Ural Group Liudmila Odnopozova Russian Federation Izhevsk Izhevsk
LLC Novosibirsk GastroCenter Ekaterina Valuyskikh Russian Federation Novosibirsk Novosibirsk
Clinical Center Bezanijska Kosa Slobodanka Crevar-Marinovic Serbia Belgrade NAP Belgrade NAP
General Hospital Dr Radivoj Simonovic Mileva Lovric Jovanovic Serbia Sombor Sombor
General Hospital Sremska Mitrovica Gordana Mitic Serbia Mitrovica Sremska
General Hospital Tatjana Latinovic Radakovic Serbia Zrenjanin Zrenjanin
Clinical Center Zvezdara Petar Svorcan Serbia Belgrade Belgrade
Clinical Center Kragujevac Gastroenterohepatology Clinic Natasa Zdravkovic Petrovic Serbia Kragujevac Kragujevac
China Medical University Hospital Jen-Wei Chou 中国台湾 台湾 台中市
Health management center Chia-Hung Tu 中国台湾 台湾 台北
Mersin University Medical Faculty Engin Altintas Turkey Mersin Yeni?ehir
Antalya Training and Research Hospital Ayhan Cekin Turkey Antayla Muratpasa
Kocaeli University Medical Faculty Hospital Sadettin Hulagu Turkey Kocaeli Izmit
Ege University Medicine of Faculty Omer Ozutemiz Turkey Turkey Izmir
Acibadem Universitesi - Acibadem Kozyatagi Hastanesi Can Gonen Turkey Istanbul Kad?koy
Kyiv Municipal Clinical Hospital #1 Inna Markevych Ukraine Kyiv Kyiv
Communal Institution Igor Skrypnyk Ukraine Poltava Poltava
Communal City Clinical Hospital of Ambulance Valeriy Vdovychenko Ukraine Lviv Lviv
Communal Enterprise Olena Levchenko Ukraine Odesa Odesa
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU Valerii Ivanov Ukraine Vinnytsia Vinnytsia
Communal institution of the Kyiv Regional Council “Kyiv Regional Clinical Oncology Dispensary” Tetiana Lohdanidi Ukraine Kyiv Kyiv
Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Yaroslav Zborivskyy Ukraine Liviv Liviv
Medical Centre CONSILIUM MEDICAL Oksana Gerasymenko Ukraine Kyiv Kyiv
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2 Viacheslav Neshta Ukraine Zaporizhzhia Zaporizhzhia
DIASERVIS LTD Oleksandr Oliinyk Ukraine Zaporizhzhia Zaporizhzhia
MCIC MC LLC Health Clinic Oleksandr Golovchenko Ukraine Ukraine Vinnytsia
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2 Oleksii Datsenko Ukraine Kharkiv Kharkiv
GI L.T. Malaya TI Namsu Galyna Fadieienko Ukraine Kharkiv Kharkiv
A. Novak Transcarpathian Regional Clinical Hospital Iaroslava Rishko Ukraine Uzhgorod Uzhgorod
Kharkiv City Student Hospital Oleksii Oparin Ukraine Kharkiv Kharkiv
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus Viktorya Shevchuk Ukraine Kropyvnytskyi Kropyvnytskyi
CI Kherson CCH Alla Malytska Ukraine Kherson Kherson
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta Olha Ivanishyn Ukraine Lviv Lviv
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM Halyna Tomashkevych Ukraine Vinnytsia Vinnytsia
Ivano-Frankivsk Regional Clinical Hospital Vira Vyshyvaniuk Ukraine Ivano-Frankivsk Ivano-Frankivsk
M.I. Pyrogov Regional Clinical Hospital Mykola Stanislavchuk Ukraine Vinnytsya Vinnytsya
Communal institution of the Kyiv Regional Council “Kyiv Regional Clinical Oncology Dispensary” Svitlana Danyliuk Ukraine Ukraine Kyiv

伦理委员会信息

名称 审查结论 审查日期
上海交通大学医学院附属仁济医院 同意 2019-09-03
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2019-09-03
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2020-04-01
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2020-11-19
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2021-05-06
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2021-07-05
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2021-11-03
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2023-02-01
上海交通大学医学院附属仁济医院医学伦理委员会 同意 2023-11-29

试验状态信息

试验状态
进行中-招募完成
目标入组人数
国内: 65 ; 国际: 1044 ;
已入组例数
国内: 166 ; 国际: 登记人暂未填写该信息;
实际入组总例数
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:2020-07-21;     国际:2018-10-19;
第一例受试者入组日期
国内:2020-08-21;     国际:登记人暂未填写该信息;
试验终止日期
国内:登记人暂未填写该信息;     国际:登记人暂未填写该信息;

临床试验结果摘要

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