登记号
CTR20192153
相关登记号
CTR20191511,CTR20192156
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
LY3074828在中度至重度活动性溃疡性结肠炎患者中的诱导期研究
试验专业题目
评价LY3074828用于传统治疗失败和生物治疗失败的中度至重度活动性溃疡性结肠炎患者的诱导期研究
试验方案编号
I6T-MC-AMAN; 2018年3月13日
方案最近版本号
I6T-MC-AMAN(6 .2) 临床研究方案附录
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LY3074828用于对UC的常规或生物疗法反应不足，反应丧失或不耐受的中度至重度活动性溃疡性结肠炎（UC）患者的安全性和有效性
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
无
入选标准
- 在基线前至少3个月确诊为UC
- 根据改良的Mayo评分（MMS）确认患有中度至重度活动性UC
- 表现出对UC的常规或生物疗法反应不足，反应丧失或不耐受
- 如果是女性，必须符合避孕要求
- 已提供了经管理研究中心的伦理审查委员会（ERB）批准的书面知情同意
- 静脉通路足以按照研究方案进行血液样本采集和静脉给药
- 具有延伸至近端直肠的UC证据
- 存在以下记录：a.对于以下患者，具有基线前12个月内的监测结肠镜检查（按当地标准进行）： 持续时间大于 8年的全结肠炎患者，或持续时间大于 12年的左侧结肠炎患者，或原发性硬化性胆管炎患者,或b.对于不适用纳入标准a的患者，具有最新的结直肠癌监测（按当地标准进行）。根据研究者酌情判断，可进行结肠镜检查（而不是软式乙状结肠镜检查）作为本研究的筛选内镜检查。源文件中无结肠镜报告的患者将在筛选时接受结肠镜检查
- 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
- 在首次筛选时年龄≥18岁至≤80岁的男性或女性患者
- 男性患者： 除遵守具体的地方政府研究要求以外，无男性避孕要求
- 育龄女性患者： a.必须在开始治疗前妊娠试验阴性，根据筛选访视时血清妊娠试验阴性。b.且随后暴露前24小时内尿妊娠试验阴性；且必须同意保持禁欲（如果完全禁欲是其偏好的常规生活方式），或保持同性性关系（如果同性性关系是其偏好的常规生活方式），而不与男性发生性关系。不接受定期禁欲（例如日历法、排卵法、体温法、排卵后法）、声称仅在临床试验持续期间禁欲和体外射精法作为避孕方法。或必须在整个研究期间使用2种有效的避孕方法。在完成研究药物给药后，必须继续禁欲或避孕20周：i. 将使用两种有效的避孕方法（例如带杀精剂的男用或女用避孕套、带杀精剂的隔膜或者宫颈海绵）。患者可以选择使用双重屏障避孕法。不含杀精剂的屏障保护法不是一种可靠或可以接受的方法。因此，每种屏障法必须包括使用杀精剂。应当注意的是，不接受联合使用男用或女用避孕套作为双重屏障法，因为当联合使用这两种方法时失败率高。ii. 值得注意的是，2种避孕方法中的1种可以为高效（失败率小于1%）避孕法（例如组合口服避孕药、植入避孕药或宫内节育器）
- 非育龄女性可以参与本研究，包括符合以下情况的女性： a. 由于手术绝育（子宫切除术、双侧卵巢切除术或输卵管结扎术）、先天性异常（例如缪勒氏管发育不全）而不具有生育能力；或 b. 绝经后-定义为： i. 年龄至少50岁、子宫完整、不接受激素治疗且符合以下任一情况的女性: 月经停止至少1年，或自发闭经至少6个月，且促卵泡激素（FSH）水平 >40 mIU/mL；或 ii. 年龄55岁或以上、不接受激素治疗且自发闭经至少6个月的女性； iii. 年龄至少55岁且在开始激素替代治疗前诊断为绝经的女性
排除标准
- 目前诊断有克罗恩病、炎症性肠病 - 未分类（未定型结肠炎）
- 此前曾接受结肠切除术
- 具有中毒性巨结肠症证据
- 预先暴露于抗IL12p40抗体（例如ustekinumab）或抗IL-23p19抗体（例如risankizumab，brazikumab，guselkumab或tildrakizumab）。
- 患有遗传性免疫缺陷综合征或UC样结肠炎症的已知单基因原因
- 任何胃肠道癌症史或现病史证据
- 符合以下情况的患者： a.存在活动性结核（TB）的证据，或b.既往有活动性TB史，无论是否接受治疗，或c.在筛选时诊断为潜伏性结核感染（LTBI）
- 在基线前12个月内曾接种卡介苗（BCG），或在基线前3个月内曾接种减毒活疫苗，或打算在研究期间接受这种疫苗
- 在筛选时存在人类免疫缺陷病毒/获得性免疫缺陷综合征（HIV/AIDS），或HIV抗体检测阳性
- 存在急性或慢性乙型肝炎病毒感染；或者筛选时乙型肝炎病毒（HBV）检测呈阳性，定义为：a.乙型肝炎表面抗原阳性（HBsAg+）,或b.乙型肝炎表面抗原阴性（HBsAg-），且抗乙型肝炎核心抗体阳性（抗HBc+），同时可检测到HBV DNA,或c.可检测到的HBV DNA
- 目前存在丙型肝炎感染；或者筛选时丙型肝炎病毒（HCV）检测呈阳性，定义为：丙型肝炎抗体阳性，且HCV RNA可以检测到
- 在筛选内镜检查前30天内存在艰难梭菌或其他肠道感染，或者筛选时艰难梭菌毒素或其他肠道病原体检测呈阳性。确证为巨细胞病毒相关结肠炎的患者应在筛选内镜检查前至少3个月内进行充分的治疗且症状已消退
- 存在严重、机会性或慢性/复发性肠外感染的患者应接受充分的治疗，并在筛选前30天内停用抗生素且症状不复发。严重肠外感染包括但不限于以下情况：a.需要IV抗生素治疗的感染。b.需要住院治疗的感染 c.被视为“机会性”的感染d.慢性、复发性感染（例如骨髓炎、复发性蜂窝织炎）
- 存在非严重肠外感染的患者必须在筛选前接受了充分治疗
- 在筛选前 ≤ 8周内存在活动性/传染性带状疱疹感染证据。所有囊泡结痂前带状疱疹感染仍为活动性
- 在最近10年内发生淋巴瘤、白血病或任何恶性肿瘤
- 为直接参与本研究的研究中心人员和/或其直系亲属。直系亲属定义为配偶、父母、子女或兄弟姐妹，无论为具有血缘关系或合法收养
- 为礼来公司员工或参与本研究的第三方组织的员工
- 目前入组任何其他涉及某种试验性产品的临床研究，或者判断认为与本研究在科学或医学上不相容的任何其他类型的医学研究
- 既往曾完成或终止本研究或任何其他LY3074828研究。接受再次筛选程序的患者除外
- 存在不稳定或控制不佳的疾病，包括但不限于心脑血管、呼吸、胃肠道（UC除外）、肝脏、肾脏、内分泌、血液系统或神经系统疾病，且可能会影响研究中患者安全性或对有效性评估造成混杂影响。排除需要接受全身性糖皮质激素来治疗非UC疾病（使用糖皮质激素治疗肾上腺功能不全除外）的患者
- 曾接受实体器官移植或造血干细胞移植
- 不愿意或不能够在整个AMAN研究期间遵守使用数据采集设备来直接记录患者的每日数据，或者不能完成其他研究程序
- 研究者或申办方因任何可能损害受试者安全或对数据解释造成混杂影响的原因而认为不适合纳入本研究
- 不能完成研究程序
- 已怀孕、正在哺乳或者计划在入组研究期间或末次研究药物给药后20周内怀孕（仅限女性）
- 目前存在酒精依赖和/或药物滥用，或有最近1年内酒精依赖/药物滥用史
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:LY3074828注射液
|
用法用量:注射液；规格15ml；30分钟内静脉输注，每4周1次，用药时程：在第0、4和8周时进行，治疗持续时间为12周。
|
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
|
用法用量:注射液；规格15ml；30分钟内静脉输注，每4周1次，用药时程：在第0、4和8周时进行，治疗持续时间为12周。成分：柠檬酸钠二水合物、无水柠檬酸、氯化钠、聚山梨酯80、注射用水
|
|
中文通用名:外形与LY3074828注射液相同的安慰剂
|
用法用量:注射液；规格15ml；30分钟内静脉输注，每4周1次，用药时程：在第0、4和8周时进行，治疗持续时间为12周。成分：柠檬酸钠二水合物、无水柠檬酸、氯化钠、聚山梨酯80、注射用水
|
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12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）
有
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 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 冉志华，教授 | 医学博士 | 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 | 医学博士 | 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 | 上海 |
| 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 |
| 首都医科大学附属北京友谊医院 | 吴咏冬 | 中国 | 北京 | 北京 |
| 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 |
| 新疆医科大学第一附属医院 | 姚萍 | 中国 | 新疆 | 乌鲁木齐 |
| 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 |
| 大连医科大学附属第二医院 | 姜春萌 | 中国 | 辽宁 | 大连 |
| 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 |
| 福建省立医院 | 林志辉 | 中国 | 福建 | 福州 |
| 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 |
| 江苏省中医院 | 沈洪 | 中国 | 江苏 | 南京 |
| 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 |
| 中国医科大学附属盛京医院 | 李岩 | 中国 | 辽宁省 | 沈阳市 |
| 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 |
| Universitatsklinikum Salzburg | Sonja Gassner | Austria | Salzburg | Salzburg |
| Medical University of Vienna | Walter Reinisch | Austria | Vienna | Vienna |
| Medizinische Universitat Innsbruck | Robert Koch | Austria | Innsbruck | Innsbruck |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Marc Ferrante | Belgium | Leuven | Leuven |
| AZ Klina | Jos Callens | Belgium | Brasschaat | Brasschaat |
| Universitair Ziekenhuis Gent | Triana Lobaton Ortega | Belgium | Oost-Vlaanderen | Gent |
| Centre Hospitalier de Wallonie picarde - CHwapi A.S.B.L. | Souhail Saikali | Belgium | Tournai | Tournai |
| University Hospital Center Osijek | Vladimir Borzan | Croatia | Osijek | Osijek |
| ISCARE Clinical Centre | Milan Lukas | Czech Republic | Praha | Praha |
| Hepato-gastroenterologie HK, s.r.o. Policlinica III., Trida Edvarda | Miroslava Volfova | Czech Republic | Kralove | Hradec |
| PreventaMed, s.r.o. | Jiri Pumprla | Czech Republic | Olomouc | 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 | Plzen | Plzen |
| Fakultni nemocnice u sv. Anny v Brne Department of Cytostatics Preparation | Jan Ulbrych | Czech Republic | Brno | Brno |
| Gregar s.r.o. | Jan Gregar | Czech Republic | Olomouc | Olomouc |
| Vojenska nemocnice Brno | David Stepek | Czech Republic | Brno | Brno |
| Zealand University Hospital Koge | Signe Wildt | Denmark | Koge | Koge |
| Herlev and Gentofte Hospital | Jakob Seidelin | Denmark | Herlev | Herlev |
| Hopital de Hautepierre - Service d’Hépatogastroentérolgie | Jean-Marie Reimund | France | Bas Rhin | Strasbourg Cedex |
| Hopital Saint Eloi | Romain Altwegg | France | Montpellier | Montpellier |
| CHU Tours - Hopital Trousseau Avenue de la République | Laurence Picon | France | Indre-et | Chambray les Tours |
| Hopital Saint-Louis | Matthieu Allez | France | Paris | Paris |
| Hopital Beaujon | Xavier Treton | France | Clichy | Clichy |
| CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro | Mathurin Fumery | France | Somme | Amiens Cedex |
| CHU de Saint Etienne Hopital Nord | Xavier Roblin | France | Avenue Albert Raimond | Saint Priest en Jarez France |
| Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - | Stephane Nancey | France | Rhone | Pierre Benite cedex |
| Centre Hospitalier de Pau | Stephane Nancey | France | Pyrénées | Pau CEDEX |
| ROBERT DEBRE HOSPITAL | Guilllaume Cadiot | France | REIMS | REIMS |
| Hopital L'Archet 2 | Xavier Hebuterne | France | Alpes | Nice Cedex |
| CHU Lille - Hopital Claude Huriez | Pierre Desreumaux | France | Nord | Lille cedex |
| CHRU Nancy Brabois - Hopital d'Enfants | Camille Zallot | France | Meurthe-et-Moselle | Vandoeuvre les Nancy |
| Hopital Nord de Marseille Service de Gastro-enterologie du Pr Grimaud | Ariadne Desjeux | France | Cedex | Marseille |
| CHU Bordeaux - Hopital Haut- Lévêque | David Laharie | France | Gironde | Pessac Cedex |
| INLUGA im Haus der Gesundheit | Peter Uebel | Germany | Ludwigshafen | Ludwigshafen |
| Krankenhaus Waldfriede e. V. | Carsten Buening | Germany | Berlin | Berlin |
| Staedisches Klinikum Brandenburg | Stefan Lueth | Germany | Brandenburg | Brandenburg |
| Internistische Praxisgemeinschaft | Vassilios Kardalinos | Germany | Weyhe | Weyhe |
| Medizinische Hochschule Hanover | Ursula Seidler | Germany | Niedersachsen | Hannover |
| Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt | Lars Fechner | Germany | Sachsen Anhalt | Halle (Saale) |
| Martin-Luther-Universitat Halle- Wittenberg | Jens Walldorf | Germany | Sachsen-Anhalt | Halle (Saale) |
| Charité Universitatsmedizin Berlin Campus Buch | Britta Siegmund | Germany | Berlin | Berlin |
| Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen | Stefanie Howaldt | Germany | Hamburg | Hamburg |
| Endomedix Diagnosztikai Kozpont | Tunde Kristof | Hungary | Miskolc | Miskolc |
| Semmelweis Egyetem II.sz. Belgyogyaszati Klinika | Zsolt Tulassay | Hungary | Budapest | Budapest |
| Clinfan Szolgaltato Kft. | Agnes Salamon | Hungary | Szekszard | Szekszard |
| Obudai Egeszsegugyi Centrum Kft | Csaba Fulop | Hungary | Budapest | Budapest |
| Debreceni Egyetem Klinikai Kozpont | Istvan Altorjay | Hungary | Debrecen | Debrecen |
| DRC Gyogyszervizsgalo Kozpont Kft. | Laszlo Koranyi | Hungary | EU | Balatonfüred |
| Karolina Korhaz-Rendelointezet | Gyula Pecsi | Hungary | Mosonmagyarovar | Mosonmagyarovar |
| Szegedi Tudomanyegyetem Szent- Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika | Tamas Molnar | Hungary | Szeged | Szeged |
| Javorszky Odon Hospital | Tibor Szaloki | Hungary | Vac | Vac |
| Beaumont Hospital | Aoibhlinn O'Toole | Ireland | Dublin | Dublin |
| Presidio di Rho U.O.C. di Gastroenterologia edEndoscopia Digestiva | Simone Saibeni | Italy | Milano | Rho |
| Azienda Ospedaliero Universitaria San Martino | Maria Caterina Parodi | Italy | Genova | Genova |
| Azienda Ospedaliera Universitaria Pisana | Giovanni Monteleone | Italy | Pisa | Pisa |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata UOC di Gastroenterologia ed Endoscopia Digestiva | Giovanni Monteleone | Italy | Roma | Torre |
| Istituto Clinico Humanitas | Silvio Danese | Italy | Milano | Rozzano |
| Policlinico Univ. Agostino Gemelli | Antonio Gasbarrini | Italy | Roma | 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 | Milano | Milano |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia | Marco Marino | Italy | Udine | Udine |
| Azienda ospedaliero-universitaria Mater Domini | Francesco Luzza | Italy | Catanzaro | Catanzaro |
| Ospedale Mauriziano Umberto I | Marco Daperno | Italy | Torino | Torino |
| Ospedale Sandro Pertini | Roberta Pica | Italy | Lazio | Roma RM |
| Azienda Ospedaliera Universitaria Policlinico de Modena | Erica Villa | Italy | Modena | Modena |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) | Chiara Ricci | Italy | Brescia | Brescia |
| Digestive Diseases Center | Ivars Tolmanis | Latvia | Riga | Riga |
| Pauls Stradins Kliniska Universitates Slimnica | Juris Pokrotnieks | Latvia | Riga LV | Riga LV |
| Riga Eastern Clinical University Hospital | Ateksejs Derovs | Latvia | Riga LV | Riga LV |
| Republic Hospital of Klaipeda | Arunas Kancauskas | Lithuania | Klaipeda | Klaipeda |
| Klaipeda Seamen's Hospital | Giedrius Simulionis | Lithuania | Klaipeda | Klaipeda |
| Vilnius University Hospital Santariskiu Clinics Public Inst,Dept of Clinical Pharmacology | Ieva Stundiene | Lithuania | Vilnius LT | Vilnius LT |
| 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 | Noord Brabant | Tilburg Noord |
| Bernhoven Ziekenhuis Researchbureau MDL | Ingrid Gisbertz | Netherlands | Uden | Uden |
| UMC Utrecht, Dept. of Internal Medicine, MDL | Herma Fidder | Netherlands | Utrecht | Utrecht |
| Academisch Medisch Centrum | Mark Lowenberg | Netherlands | Noord-Holland | Amsterdam |
| Niepubliczny Zaklad Opieki Zdrowotnej SONOMED | Anna Wiechowska- Kozlowska | Poland | Szczecin | Szczecin |
| PlanetMed Sp.z o.o. | Barbara Wozniak-Stolarska | Poland | Wroclaw | Wroclaw |
| Centralny Szpital Kliniczny MSWiA Klinika Chorób Wewnetrznych i Gastroenterologii | Grazyna Rydzewska- Wyszkowska | Poland | Warszawa | Warszawa |
| Samodzielny Publiczny Szpital | Cichoz-Lach Halina | Poland | Lublin | Lublin |
| Centrum Zdrowia Matki, Dziecka i Mlodziezy (CZMDM) Przychodnie | Michal Lawinski | Poland | Warszawa | Warszawa |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne | Beata Gawdis-Wojnarska | Poland | Szczecin | Szczecin |
| NZOZ ALL-MEDICUS, Zaklad Gastroenterologii | Aldona Mularczyk | Poland | Katowice | Katowice |
| Centrum Medyczne Pratia Bydgoszcz | Marcin Sobon | Poland | Bydgoszcz | Bydgoszcz |
| PROMEDICA S.C | Lukasz Firkowski | Poland | Bedzin | Bedzin |
| KO-MED Centra Kliniczne Staszow | Jacek Kieltucki | Poland | Staszow | Staszow |
| Centrum Medyczne NeuroProtect | Maciej Gonciarz | Poland | Warszawa | Warszawa |
| Wojewodzki Specjalistyczny Szpital w Olsztynie | Tomasz Arlukowicz | Poland | Olsztyn | Olsztyn |
| ETG Zamosc | Katarzyna Wojcik | Poland | Zamosc | Zamosc |
| GASTROMED KOPON ZMUDZINSKI I WSPóLNICY SPóLKA JAWNA SPECJALISTYCZNE CENTRUM GASTROLOGII I ENDOSKOPII | Marcin Zmudzinski | Poland | Torun | Torun |
| Topolowa Medicenter | Zbigniew Wylegala | Poland | Krakow | Krakow |
| NZOZ FORMED | Beata Mroziak | Poland | Wadowice | Wadowice |
| Medicenter Nowy Targ | Przemyslaw Zycinski | Poland | Nowy Targ | Nowy Targ |
| Warsaw IBD Point Profesor Kierkus | Jaroslaw Kierkus | Poland | Warszawa | Warszawa |
| Endoskopia sp z o. o | Marek Horynski | Poland | Sopot | Sopot |
| Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej | Maria Klopocka | Poland | Kujawsko-pomorskie | Bydgoszcz |
| Vivamed | Robert Petryka | Poland | Warszawa | Warszawa |
| LexMedica Osrodek Badan Klinicznych | Jerzy Rozciecha | Poland | Wroclaw | Wroclaw |
| GASTROMED Zaklad Opieki Zdrowotnej | Wit Danilkiewicz | Poland | Lublin | Lublin |
| Hifu Terramed Conformal SRL | Theodor-Alexandru Voiosu | Romania | Bucuresti | Bucuresti |
| CCBR Clinical Research | Daniela Bartos | Romania | Bucuresti | Bucuresti |
| MedLife Grivita | Ion-Eugeniu Craciun | Romania | Bucuresti | Bucuresti |
| Spitalul Clinic Colentina | Radu Mateescu | Romania | Bucuresti | Bucuresti |
| Centrul Medical Unirea SRL | Camelia Chioncel | Romania | Bucuresti | Bucuresti |
| Spital Pelican Oradea | Alin-Horea Suta | Romania | Oradea | Oradea |
| Institutul Clinic Fundeni | George Stancu | Romania | Bucuresti | Bucuresti |
| Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica | Jozef Balaz | Slovakia | Banska | Banska |
| Gastro I s.r.o., Gastroenterologická ambulancia | Ivan Bunganic | Slovakia | Presov | Presov |
| Endomed, s.r.o.- Gastroenterologicka ambulancia | Miroslav Fedurco | Slovakia | Presov | 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 Coruna, CHUAC | Maria Teresa Diz-Lois Palomares | Spain | La Coruna | La Coruna |
| Hospital De Fuenlabrada | Fernando Bermejo San Jose | Spain | Madrid | Fuenlabrada |
| INSTITUTO DE CIENCIAS MéDICAS | Luis De Teresa Parreno | Spain | Alicante | 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 | Palmas de Gran Canaria | Palmas de Gran Canaria |
| Hospital Universitari Son Espases | Daniel Ginard Vicens | Spain | Baleares Islands | Palma de Mallorca |
| Complejo Hospitalario De Navarra Navarrabiomed Fundación Miguel Servet | Cristina Rodriguez Gutierrez | Spain | Navarra | Pamplona |
| Universitatsspital Zürich USZ Zürich Dep. Of Gastroenterologs and Hepatology | 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) and Manny Cussins Centre | Christian Selinger | United Kingdom | Vinnytsia | Leeds |
| Morriston Hospital | Mesbah Rahman | United Kingdom | Wales | Swansea |
| Queens Hospital | Leena Sinha | United Kingdom | Essex | Romford |
| St Thomas' Hospital | Mark Samaan | 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 | Quebec | Greenfield Park |
| Texas Digestive Disease Consultants | Timothy Ritter | United States | TX | Southlake |
| Minnesota Gastroenterology, P.A. | Daniel Van Handel | United States | MN | Plymouth |
| Maricopa Integrated Health System | Keng-Yu Chuang | United States | AZ | Phoenix |
| Digestive Disease Associates, Ltd. | Nirav Shah | United States | PA | Wyomissing |
| Wellness Clinical Research | Lucky Flores | United States | FL | Hialeah |
| Clinical Research Institute of Michigan, LLC | Ronald Fogel | United States | MI | Chesterfield |
| Digestive Healthcare of Georgia | Michael Galambos | United States | GA | Atlanta |
| Emeritas Research Group | Satinder Gill | United States | VA | Leesburg |
| Digestive Health Associates of Texas | Harry Sarles | United States | TX | Garland |
| Carolina Digestive Diseases | Phillip Goldstein | United States | NC | Greenville |
| Northwell Health | Keith Sultan | United States | NY | Great Neck |
| Paramount Medical Research | Mazen Issa | United States | OH | Middleburg Heights |
| Weill Cornell Medical College | Ellen Scherl | United States | NY | New York |
| Gastro One | Ziad Younes | United States | TN | Germantown |
| Huron Gastroenterology Associates | Najm Soofi | United States | MI | Ypsilanti |
| Biopharma Informatic, LLC | James Maher | United States | TX | Houston |
| University of Oklahoma Health Sciences Center | Richard Harty | United States | OK | Oklahoma City |
| Research Associates of South Florida, LLC | Javier Sobrado | United States | FL | Miami |
| Carilion Clinic Gastroenterology | Maithili Chitnavis | United States | VA | Roanoke |
| Henry Ford Health System Gastroenterology/Hepatology | Nirmal Kaur | United States | MI | Novi |
| Grand Teton Research Group, PLLC | Clint Behrend | United States | ID | Idaho Falls |
| UCSF Medical Center at Mission Bay | Melvin Heyman | United States | CA | San Francisco |
| Southern Star Research Institute, LLC | Jeff Bullock | United States | TX | San Antonio |
| Nola Research Works, LLC | Vivek Huilgol | United States | LA | New Orleans |
| Midwest Medical Care | Chandar Singaram | United States | SD | Sioux Falls |
| California Medical Research Group | Calin Arimie | United States | CA | Northridge |
| DCR-PI, PC | Connie Hsu | United States | AZ | Litchfield Park |
| Care Access Research | Mark Kogan | United States | CA | Berkeley |
| Gastroenterology Research of San Antonio | Nicholas Martinez | United States | TX | San Antonio |
| Nature Coast Clinical Research, LLC | Paul Hellstern | United States | FL | Inverness |
| Central Sooner Research | Robert Gordon | United States | OK | Norman |
| Gastroenterology Associates of Pensacola, PA | Frederic Newman | United States | FL | Pensacola |
| Indiana University School of Medicine | Sashidhar Sagi | United States | IN | Indianapolis |
| Florida Digestive Specialist | Jayaprakash Kamath | United States | FL | St. Petersburg |
| Wisconsin Center for Advanced Research | Brian Moloney | United States | WI | Milwaukee |
| University of North Carolina | Animesh Jain | United States | NC | Chapel Hill |
| Digestive Health Specialists of the Southeast | Paul Lamb | United States | AL | Dothan |
| Florida Hospital | Hasan Muhammad | United States | FL | Orlando |
| Clinical Applications Laboratories, Inc. | Vijayalakshmi Pratha | United States | CA | San Diego |
| Om Research, LLC | Jatinder Pruthi | United States | CA | Lancaster |
| Gastro Florida | Michael Weiss | United States | FL | Clearwater |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Curtis Baum | United States | KS | Topeka |
| Gastroenterology Associates of Western Michigan, P.L.C. | Allan Coates | United States | MI | Wyoming |
| NorthShore University HealthSystem | Eugene Yen | United States | IL | Evanston |
| Physicians Research Group | Doo-Sang Cho | United States | AZ | Tempe |
| Care Access Research LLC - Salt Lake City | Chad Gonzales | United States | UT | Ogden |
| Care Access Research LLC | Glenn Freed | United States | PA | Pottsville |
| Texas Digestive Disease Consultants | Timothy Ritter | United States | TX | Southlake |
| Care Access Research - Youngstown | Sayed Yossef | United States | OH | Poland |
| Texas Digestive Disease Consultants | Jonathon Chapman | United States | LA | Baton Rouge |
| Valley Gastroenterology Cnslts | Elias Tarakji | United States | CA | Arcadia |
| Houston Methodist Research Ins | Bincy Abraham | United States | TX | Houston |
| Florida Medical Clinic LLC | Mark Eisner | United States | FL | Zephyrhills |
| SIH Research, LLC | Syed Mumtaz | United States | FL | Kissimmee |
| Clintheory Healthcare | Souheil Moussly | United States | FL | Orlando |
| Columbus Clinical Services, LLC | Sara Llerena | United States | FL | Miami |
| Galen Medical Group | Colleen Schmitt Galen | United States | TN | Hixson |
| Direct Helpers Medical Center | Manuel Fernandez | United States | FL | Hialeah |
| Digestive Health Specialists | William Holderman | United States | WA | Tacoma |
| Delta Research Partners LLC | Bal Raj Bhandari | United States | LA | Monroe |
| Mautalen Salud e Investigacion- Centro de Osteopatías Médicas | Emiliano Tron | Argentina | Buenos Aires | Ciudad Autonoma de Buenos Air |
| CER Instituto Medico | Edgardo Gimenez | Argentina | Buenos Aires | 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 | Buenos Aires | CABA |
| 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 |
| Melbourne Gastrointestinal Investigation Unit (MGIU) | Henry Debinski | Australia | Victoria | Malvern |
| Royal Adelaide Hospital | Abdul Shaikh | Australia | SA | Adelaide |
| The Alfred Hospital | Miles Sparrow | Australia | VIC | Melbourne |
| The Royal Melbourne Hospital | Finlay Macrae | Australia | VIC | Parkville |
| Box Hill Hospital | Olga Niewiadomski | Australia | VIC | Box Hill |
| Princess Alexandra Hospital | Gerald Holtmann | Australia | Queensland | Brisbane |
| Mater University Hospital | Jakob Begun | Australia | QLD | South Brisbane |
| M S Ramaiah Medical College Hospital | Avinash Balekuduru | India | Karnataka | Bangalore |
| Sir Ganga Ram Hospital | Naresh Bansal | India | Delhi | New Delhi |
| 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 Department of Surgical | 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 | Nishant Nagpal | 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 | Telangana |
| SSKM Post Graduate Hospital | Rajib Sarkar | India | West Bengal | Kolkata |
| Lokmanya Hospital | Meghraj Ingle | India | Maharashtra | Mumbai |
| 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 |
| Meir Medical Center | Timna Naftali | Israel | Kfar Saba | Kfar Saba |
| Galilee Medical Center Department of Internal Medicine A | Assy Nimer | Israel | Nahariya | Nahariya |
| Shaare Zedek Medical Center | Eran Goldin | Israel | Jerusalem | Bait Vagan |
| Kaplan Medical Center | Ehud Melzer Kaplan | 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 |
| Osaka University Hospital | Hideki Iijima | Japan | Osaka | Suita-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 | Tomoyuki Masuda | Japan | Gunma | Takasaki |
| Kawasaki Municipal Kawasaki Hospital | Hanae Takagi | Japan | Kanagawa | Kawasaki |
| Dong-A University Hospital | Jonghun Lee | Korea, South | Pusan-Kwangyǒkshi | Busan |
| Kangbuk Samsung Hospital | Dong II Park | Korea, South | Seoul-teukbyeolsi | Seoul |
| Asan Medical Center | Sang Hyoung Park | Korea, South | Korea | Seoul |
| Samsung Medical Center | YoungHo Kim | Korea, South | Seoul-teukbyeolsi | Seoul |
| Severance Hospital | Hyun-Soo Kim | Korea, South | Gangwon-do | Wonju-si |
| The Catholic University of Korea, St. Vincent's Hospital | Kang-Moon Lee | Korea, South | Gyeonggi-do | Suwon-si |
| Kyung Hee University Hospital | Hyo-Jong Kim | Korea, South | Korea | Seoul |
| 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 | Jung-gu |
| 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 | Jose Gilberto Romero Lozano | Mexico | Distrito Federal | Mexico City |
| 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 | St. Petersburg | St. 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 | Novgorod | Nizhniy |
| 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 | Elina Petrova | 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 | NAP | Belgrade |
| 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 No. 2, Yude Rd. | Jen-Wei Chou | 中国台湾 | 台湾 | 台中 |
| Health management center | Chia-Hung Tu | 中国台湾 | 台湾 | 台北 |
| Mersin University Medical Faculty | Engin Altintas | Turkey | Mersin | Yenisehir |
| Antalya Training and Research Hospital | Ayhan Cekin | Turkey | Antayla | Muratpasa |
| Kocaeli University Medical Faculty Hospital | Sadettin Hulagu | Turkey | Kocaeli | Izmit |
| Gazi University Faculty of Medicine | Tarkan Karakan | Turkey | Ankara | Besevler |
| Ege University Medicine of Faculty Gastroenterology Department | Omer Ozutemiz | Turkey | Turkey | Izmir |
| Acibadem Universitesi - Acibadem Kozyatagi Hastanesi | Can Gonen | Turkey | Istanbul | Kadkoy |
| Kyiv Municipal Clinical Hospital | 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 | Olena 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 | 同意 | 2020-04-01 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2020-11-19 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2021-05-06 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2021-07-05 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2021-11-03 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2023-02-01 |
| 上海交通大学医学院附属仁济医院 | 同意 | 2023-11-29 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 184 ；
国际: 1160 ；
已入组例数
国内: 184 ；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 184 ；
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：2020-01-16；
国际：2018-06-18；
第一例受试者入组日期
国内：2020-04-22；
国际：登记人暂未填写该信息；
试验终止日期
国内：2024-09-19；
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
