登记号
CTR20211113
相关登记号
CTR20211116,CTR20211103
曾用名
药物类型
化学药物
临床申请受理号
JXHL1800109
适应症
克罗恩病
试验通俗题目
一项口服OZANIMOD 作为中度至重度活动性克罗恩病的维持治疗的安慰剂对照研究
试验专业题目
一项评估口服OZANIMOD作为中度至重度活动性克罗恩病的维持治疗的III期、多中心、随机、双盲、安慰剂对照研究
试验方案编号
RPC01-3203
方案最近版本号
Amendment7.0
版本日期
2024-02-06
方案是否为联合用药
否
申请人信息
申请人名称
联系人姓名
戚佩雯
联系人座机
021-83196211
联系人手机号
13760723209
联系人Email
pace.qi@bms.com
联系人邮政地址
广东省-广州市-广州市天河区天河路208号粤海天河城大厦41楼03单元
联系人邮编
510000
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
这是一项评估口服OZANIMOD 作为中度至重度活动性克罗恩病的维持治疗的III 期、多中心、随机、双盲、安慰剂对照研究
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
12岁(最小年龄)至
75岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 受试者在进入诱导研究（RPC01-3201或RPC01-3202）时符合入选标准，且完成了诱导研究第12周疗效评估。
- 进行任何研究相关程序之前，受试者不应受到当地法规的任何限制且必须提供书面知情同意书，并能够遵守事件表。
- 受试者处于临床应答（CDAI较基线降低≥100分或CDAI评分<150分）和/或临床缓解（CDAI 评分 < 150 分）和/或研究第12周时平均每日排便次数评分≤3分，平均腹痛评分≤1，腹痛和排便次数相对于基线没有恶化。
- 有生育能力的女性受试者（FCBP） 注意：出于本研究的目的，如果女性受试者1）未接受子宫切除术（手术切除子宫）或双卵巢切除术（手术切除双侧卵巢），或者2）至少连续24个月未绝经（即在过去24个月内的任何时间有月经）则认为其具有生育能力。 必须同意在整个研究过程中采取高效的避孕方法，直到完成90天安全性随访访视。高效避孕方法是指始终和正确使用一种或合用多种避孕方法时导致的珀尔指数失败率小于1%/年。本研究中可接受的避孕方法如下： 联合激素（含雌激素和孕激素）避孕药，可以是口服、阴道内或透皮给药 与抑制排卵相关的仅含孕激素的激素避孕，可以是口服、注射或植入式 放置宫内节育器（IUD） 放置宫内激素释放系统（IUS） 双侧输卵管阻塞 输精管切除的伴侣 完全禁欲 定期禁欲（日历法、症状体温法、排卵后方法）、体外射精（性交中断）、仅使用杀精剂和哺乳期闭经方法都是不可接受的避孕方法。 必须对有生育能力的女性受试者进行关于妊娠注意事项和胎儿暴露潜在风险的咨询。研究者将酌情在第1天对所有FCBP进行避孕方法或禁欲的不同选择的健康教育。每次改变避孕措施/方法或妊娠能力时，将对受试者进行再教育。女性受试者选择的避孕方式必须在女性受试者被随机分配至研究时有效（例如，激素避孕应在随机分配前至少28天开始）。
排除标准
- 受试者患有任何有临床意义的心血管、肝脏、神经、肺（严重呼吸道疾病[肺纤维化或COPD]）、眼科、内分泌、精神疾病或其他重大全身性疾病，使得实施方案或研究解释产生困难或使参与研究受试者面临风险。
- 受试者有疑似或确诊的腹腔或肛周脓肿，未给予适当治疗。
- 自诱导研究第1天起，受试者接受了肠切除术（部分或全部）、小肠切除术或造口术（即暂时性结肠造口术、永久性结肠造口术、回肠造口术或其他肠造口术）或发生有症状的瘘管（肠外或肠-肠内）。
- 受试者在5年内有活动性癌症，包括实体瘤和恶性血液肿瘤（除外皮肤基底细胞癌或原位鳞状细胞癌或宫颈异常增生/已切除和恢复的宫颈癌）或尚未完全治愈的结肠非典型增生
- 受试者在诱导研究期间接受了以下任一种治疗 a. 直肠糖皮质激素治疗（即经直肠或乙状结肠通过泡沫或灌肠给予糖皮质激素） b. 基线（诱导阶段）后开始应用或增加糖皮质激素的剂量大于筛选至基线访视之间的最大日剂量，以治疗CD加重 c. 直肠5-氨基水杨酸盐（ASA）（即经直肠给予5-ASA） d. 胃肠外途径给予糖皮质激素>14天 e. 全胃肠外营养治疗 f. 应用抗生素治疗CD g. 免疫调节剂（6-MP、AZA，包括但不限于环孢霉素、霉酚酸酯、他克莫司和雷帕霉素） h. 免疫调节生物制剂以及CD的其他治疗，如etrasimod、filgotinib、upadacitinib i. 研究性药物 j. 单采术
- 维持研究期间，受试者正在应用或计划应用免疫调节剂治疗（例如AZA、6-MP或MTX）
- 受试者长期使用非甾体类抗炎药（NSAID）（注：允许偶尔使用非甾体抗炎药和对乙酰氨基酚[例如，头痛、关节炎、肌痛或痛经]，以及阿司匹林，最高325 mg /day）
- 受试者应用Ia类或III类抗心律失常药物治疗,联合使用两种或两种以上已知延长PR间期的药物，或使用表7中提供的其他禁用系统性心脏药物治疗。
- 受试者在IP首次给药前4周内接种了活疫苗或减毒活疫苗
- 受试者既往接受过淋巴细胞消除疗法（例如，Campath™、抗CD4、克拉屈滨、利妥昔单抗、奥瑞珠单抗、环磷酰胺、米托蒽醌、全身放疗、骨髓移植、阿仑单抗或达珠单抗）
- 受试者在诱导期 IP 首次给药前8周内既往接受过D-青霉胺、来氟米特或沙利度胺治疗
- 受试者在诱导筛选开始前16周内接受过既往环孢霉素、他克莫司、西罗莫司或霉酚酸酯治疗
- 受试者在诱导期IP首次给药前3个月内有静脉免疫球蛋白（IVIg）治疗史，或血浆置换史
- 受试者接受乳腺癌耐药蛋白（BCRP）抑制剂（如环孢菌素，艾曲泊帕）
- 受试者正在接受以下任何一种药物治疗或干预措施： a. CYP2C8诱导剂（例如：利福平） b. 单胺氧化酶抑制剂（例如：司来吉兰，苯乙肼）
- 诱导期符合停药标准的受试者
- 受试者出现任何研究者认为可能使其处于危险之中的临床显著异常（如实验室或ECG）。
- 受试者为孕妇、哺乳期妇女，或随机前尿液 β 人绒毛膜促性腺激素（β-hCG） 检测为阳性。
- 对ozanimod或安慰剂的活性成分或辅料超敏
- 受试者既往接受过那他珠单抗、芬戈莫德或其他S1P调节剂治疗。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:盐酸奥扎莫德胶囊
|
剂型:胶囊剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
剂型:胶囊剂
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| CDAI 评分< 150的受试者比例 | 第52周 | 有效性指标 |
| SES-CD较基线降低≥50%的受试者比例 | 第52周 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 平均每日腹痛评分≤1分、平均每日排便次数评分≤3分伴随腹痛和排便次数较基线无恶化的受试者比例 | 第52周 | 有效性指标 |
| CDAI较基线降低≥100分或CDAI评分<150的受试者比例 | 第52周 | 有效性指标 |
| CDAI评分 <150 且在过去12周内保持无皮质类固醇使用 的受试者比例 | 第52周 | 有效性指标 |
| 随机化前 CDAI 评分<150 的受试者中第 52 周时 CDAI 评分<150 的受试者比例 | 第52周 | 有效性指标 |
| 随机化前CDAI 评分<150 分的受试者中，第52周时 CADI评分<150，且第8周和第52周（均含）之间≥80%的访视CDAI评分 < 150的受试者比例 | 第52周 | 有效性指标 |
| 平均每日腹痛评分≤1分、平均每日排便次数≤3分、且腹痛和排便次数相对于基线未恶化、SES-CD相对于基线降低≥50％的受试者比例 | 第52周 | 有效性指标 |
| 第52周时 SES-CD ≤ 4分、SES-CD相对于基线降低 ≥ 2分且没有SES-CD分项评分> 1分的受试者比例 | 第52周 | 有效性指标 |
| 第52周时CDAI评分<150和SES-CD相对于基线降低≥50%的受试者比例 | 第52周 | 有效性指标 |
| 第52周时，平均每日腹痛评分≤1分、平均每日排便次数评分≤3分伴随腹痛、排便次数相对于基线没有恶化、以及SES-CD≤4分、SES-CD降低≥2分且没有SES-CD分项评分> 1分的受试者比例 | 第52周 | 有效性指标 |
| 第52周时CDAI较基线减少≥100分或CDAI评分<150和SES-CD较基线降低≥50%的受试者比例 | 第52周 | 有效性指标 |
| 维持阶段第1天时CDAI评分< 150且第52周时SES-CD较基线减少≥50%的受试者比例 | 第52周 | 有效性指标 |
| 第52周时CDAI较基线减少≥70分的受试者比例 | 第52周 | 有效性指标 |
| 在维持阶段第1天接受糖皮质激素的所有受试者中，第52周CDAI评分 < 150且在第52周前的12周内未使用糖皮质激素的受试者比例 | 第52周 | 有效性指标 |
| 第52周时粘膜愈合（SES-CD≤4 分、SES-CD 降低≥2 分且没有SES-CD分项评分> 1分）和基于 Roberts 组织学指数（RHI）评估的组织学改善的受试者比例 | 第52周 | 有效性指标 |
| 复发时间（CDAI评分较维持研究第1天增加 ≥100分，和CDAI评分> 220分、SES-CD≥6分【或孤立性回肠疾病，≥4分】，并排除与基础CD无关的疾病活动度增加的其他原因（例如感染、药物变化） | 第52周 | 有效性指标 |
| 第52周时克罗恩病内镜严重程度指数（CDEIS）较基线降低≥50%的受试者比例 | 第52周 | 有效性指标 |
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 | |
|---|---|---|---|---|---|---|---|
| 曹倩 | 医学博士 | 主任医师 | 13588706896 | caoq@srrsh.com | 浙江省-杭州市-庆春东路 3 号 | 310016 | 浙江大学医学院附属邵逸夫医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 浙江大学医学院附属邵逸夫医院 | 曹倩 | 中国 | 浙江省 | 杭州市 |
| 中国人民解放军总医院第七医学中心 | 盛剑秋 | 中国 | 北京市 | 北京市 |
| 北京大学第三医院 | 丁士刚 | 中国 | 北京市 | 北京市 |
| 广州市第一人民医院 | 聂玉强 | 中国 | 广东省 | 广州市 |
| 华中科技大学同济医学院附属同济医院 | 田德安 | 中国 | 湖北省 | 武汉市 |
| 华中科技大学同济医学院附属协和医院 | 侯晓华 | 中国 | 湖北省 | 武汉市 |
| 首都医科大学附属北京友谊医院 | 吴咏冬 | 中国 | 北京市 | 北京市 |
| 武汉大学人民医院 | 丁一娟 | 中国 | 湖北省 | 武汉市 |
| 吉林大学第一医院 | 时阳 | 中国 | 吉林省 | 吉林市 |
| 中山大学附属第六医院（广东省胃肠肛门医院） | 高翔 | 中国 | 广东省 | 广州市 |
| 南京医科大学第一附属医院（江苏省人民医院） | 张国新 | 中国 | 江苏省 | 南京市 |
| 南昌大学第一附属医院 | 陈幼祥 | 中国 | 江西省 | 南昌市 |
| 安徽省立医院 | 解丽 | 中国 | 安徽省 | 合肥市 |
| 上海市东方医院 | 钟岚 | 中国 | 上海市 | 上海市 |
| 郑州大学第二附属医院 | 冯百岁 | 中国 | 河南省 | 郑州市 |
| 天津医科大学总医院 | 王邦茂 | 中国 | 天津市 | 天津市 |
| 昆明医科大学第一附属医院 | 李红缨 | 中国 | 云南省 | 昆明市 |
| 东南大学附属中大医院 | 施瑞华 | 中国 | 吉林省 | 吉林市 |
| 吉林大学中日联谊医院 | 王江滨 | 中国 | 吉林省 | 吉林市 |
| 中南大学湘雅二医院 | 刘德良 | 中国 | 湖南省 | 长沙市 |
| 上海市第一人民医院 | 陆伦根 | 中国 | 上海市 | 上海市 |
| 蚌埠医学院第一附属医院 | 王启之 | 中国 | 安徽省 | 蚌埠市 |
| 复旦大学附属华山医院 | 戎兰 | 中国 | 上海市 | 上海市 |
| 无锡市人民医院 | 占强 | 中国 | 江苏省 | 无锡市 |
| 西南医科大学附属医院 | 邓明明 | 中国 | 四川省 | 泸州市 |
| 常州市第一人民医院 | 王玫 | 中国 | 江苏省 | 常州市 |
| 中国人民解放军第四军医大学唐都医院 | 王新 | 中国 | 陕西省 | 西安市 |
| 上海交通大学医学院附属新华医院 | 葛文松 | 中国 | 上海市 | 上海市 |
| 长海医院 | 杜奕奇 | 中国 | 上海市 | 上海市 |
| 南京鼓楼医院 | 于成功 | 中国 | 江苏省 | 南京市 |
| 四川大学华西医院 | 王玉芳 | 中国 | 四川省 | 成都市 |
| 西安国际医学中心 | 张方信 | 中国 | 陕西省 | 西安市 |
| 中南大学湘雅医院 | 徐美华 | 中国 | 湖南省 | 长沙市 |
| 福建医科大学附属第一医院 | 王承党 | 中国 | 福建省 | 福州市 |
| 上海交通大学医学院附属瑞金医院 | 邹多武 | 中国 | 上海市 | 上海市 |
| 广东省人民医院 | 沙卫红 | 中国 | 广东省 | 广州市 |
| Sanatorio 9 de Julio S.A.-CICE 9 de Julio | Abel Novillo | Argentina | Tucuman | San Miguel de Tucuman |
| Hospital Privado Centro Médico de Cordoba | Domingo Balderramo | Argentina | N/A | Córdoba |
| Hospital Provincial del Centenario | Orlando Ruffinengo | Argentina | Santa Fe | Rosario |
| CER Medical Institute-Quilmes | Edgardo Gimenez | Argentina | N/A | Quilmes |
| Diagnostic&Therap-ic Gastro-gy | Silvina Goncalves | Argentina | N/A | Buenos Aires |
| St Vincent's Hospital Melbourne | John Nik Ding | Australia | Victoria | Fitzroy |
| Zuellig Pharma SSG Australia | Reme Mountifield | Australia | South Australia | Bedford park |
| Royal Adelaide Hospital | Vinh-An Phan | Australia | South Australia | Adelaide |
| Liverpool Hospital | Susan Connor | Australia | New South Wales | Liverpool |
| Concord Repatriation General Hosptial | Rupert Leong | Australia | New South Wales | Concord |
| Princesss Alexandra Hospital | Gerald Holtmann | Australia | Queensland | Woolloongabba |
| Mater Hospital Brisbane | Jakob Begun | Australia | Queensland | South Brishane |
| Coastal Digestive Health Pty L | Hansjoerg Seltenreich | Australia | Queensland | Maroorchydore |
| Monash Health | Gregory Moore | Australia | Victoria | Clayton |
| John Hunter Hospital | Lay Gan | Australia | New South Wales | New Lambton |
| Nepean Hospital | Jeff Chang | Australia | New South Wales | Kingswood |
| Queen Elizabeth Hospital | James Fon | Australia | South Australia | Woodville |
| Wollongong Hospital | Thomas Lee | Australia | NSW | Wollongong |
| Alfred Hospital | Miles Sparrow | Australia | n/a | Melbourne |
| Medical University Vienna | Walter Reinisch | Austria | Wien | Vienna |
| University Hospital Innsbruck | Robert Koch | Austria | Tirol | Innsbruck |
| University Hospital St.Poelten | Andreas Mayer | Austria | Nieder sterreich | St. Poelten |
| Vitebsk Regional Center | Henadz Yupatau | Belarus | Vitebskaya oblast' | Vitebsk |
| Grodno City Hospital #4 | Elena Bozhko | Belarus | Grodnenskaja oblast' | Grodno |
| Clinique du Montlégia | Arnaud Colard | Belgium | Liege | Liege |
| Sart Tilman Hospital, Department of Gastroenterology and Hepatology | Edouard Louis | Belgium | Liege | Liege |
| University Hospital Antwerp (UZA) | Elisabeth Macken | Belgium | Antwerp | Edegem |
| University Hospital Brussels | Liv Vandermeulen | Belgium | Brussels Hoofdstedelijk Gewest | Brussels |
| University Hospitals Leuven | Severine Vermeire | Belgium | Vlaams Brabant | Leuven |
| University Clinical Centre of | Stevan Trbojevic | Bosnia and Herzegovina | Republika Srpska | Banja Luka |
| Medical Center Synexus Sofia | Mariana Radicheva | Bulgaria | n/a | Stara Zagora |
| Medical Center Synexus Sofia | Veselin Kolchakov | Bulgaria | n/a | Sofia |
| Medline Multiprofile Hospital | Apostol Georgiev | Bulgaria | Plovdiv | Plovdiv |
| ACIBADEM City Clinic | Asen Petrov | Bulgaria | Sofia-Grad | Sofia |
| Sveti Ivan Rilski Hospital | Zoia Spassova | Bulgaria | Sofia-Grad | Sofia |
| ACIBADEM City Clinic Tokuda Ho | Simeon Stoynov | Bulgaria | Sofia-Grad | Sofia |
| Tsaritsa Yoanna ISUL Hospital | Plamen Penchev | Bulgaria | Sofia | Sofia |
| Kanev University Hospital | Galina Vasileva | Bulgaria | Ruse | Ruse |
| LHSC - Victoria Hospital | Terry Ponich | Canada | Ontario | London |
| London Health Sciences Centre - University Hospital | Vipul Jairath | Canada | Ontario | London |
| Brandon Medical Arts Clinic | Sonny Dhalla | Canada | Manitoba | Brandon |
| Kensington Screening Clinic | Ian Bookman | Canada | Ontario | Toronto |
| Fraser Clinical Trials, Inc | Kenneth Atkinson | Canada | British Columbia | New Westminster |
| Mount Sinai Hospital | Hillary Steinhart | Canada | Ontario | Toronto |
| G.I. Research Institute (G.I.R.I.) | Yvette Leung | Canada | British Columbia | Vancouver |
| Allen Lim Professional Corp | Allen Lim | Canada | Alberta | Edmonton |
| The Ottawa Hospital - General Campus | Richmond Sy | Canada | Ontario | Ottawa |
| Toronto Digestive Disease Associates Inc | Michael Gould | Canada | Ontario | Vaughan |
| University of Calgary | Remo Panaccione | Canada | Alberta | Calgary |
| CECIM | Elizabeth Arriagada Hernandez | Chile | n/a | Santiago |
| De La Costa Clinic Ltd. | Leonardo Brochado Fontalvo | Colombia | Atlántico | Barranquilla |
| University Hospital Zagreb | Zeljko Krznaric | Croatia | Zagrebaka upanija | Zagreb |
| Synexus Czech s.r.o. | Vaclav Smid | Czech Republic | n/a | Prague |
| Military Hospital Brno | David Stepek | Czech Republic | Brno-venkov | Brno |
| ISCARE a.s. | Milan Lukas | Czech Republic | Praha 9 | Prague |
| PreventaMed s.r.o. | Jiri Pumprla | Czech Republic | Olomouc | Olomouc |
| St. Anne's University Hospital | Jan Ulbrych | Czech Republic | Jihomoravsky kraj | Brno |
| Hepato-Gastroenterology HK s.r | Tomas Vanasek | Czech Republic | Hradec Kralove | Hradec Kralove |
| Regional Hospital Pardubice | Petr Vyhnalek | Czech Republic | Pardubice | Pardubice |
| Gastroenterology and Endoscopy | Vlastimil Woznica | Czech Republic | Most | Most |
| Institute of Clinical and Experimental Medicine (IKEM) | Pavel Drastich | Czech Republic | Praha 4 | Prague |
| University Hospital of Rouen | Guillaume Savoye | France | Haute-Normandie | Rouen |
| Hopital Albert Michallon | Nicolas Mathieu | France | Isère | Grenoble Cedex 9 |
| Dijon University Hospital | Christophe Michiels | France | Cte-d'Or | Dijon |
| South Lyon Hospital Center | Stephane Nancey | France | n/a | Pierre-Benite |
| North Hospital | Xavier Roblin | France | Loire | Saint-Priest-en-Jarez |
| Nantes University Hospital | Mathurin Flamant | France | n/a | Nantes |
| Hopital Claude Huriez | Pierre Desreumaux | France | Nord | Lille |
| University Hosp. Center Caen | Marie-Astrid Piquet | France | Calvados | Caen |
| Blois Hospital | Dany Gargot | France | Loir-et-Cher | Blois |
| Amiens Picardie Hospital | Mathurin Fumery | France | Somme | Amiens |
| Hospital Pontchaillou | Guillaume Bouguen | France | Ille-et-Vilaine | Rennes |
| Hospital de Rangueil | Cyrielle Gilletta De Saint Joseph | France | Haute-Garonne | Toulouse |
| Louis Mourier Hospital | Benoit Coffin | France | Hauts-de-Seine | Colombes |
| North Hospital | Melanie Serrero | France | Provence-Alpes-Cte-d'Azur | Marseille |
| Beaujon Hospital | Xavier Treton | France | le-de-France | Clichy |
| Creteil Intercommunal Hospital | Herve Hagege | France | Val-de-Marne | Creteil |
| Medical Center | George Gvilia | Georgia | n/a | Tbilisi |
| Israeli-Georgian MRC Helsicore | Nodar Emukhvari | Georgia | Tbilisi | Tbilisi |
| JSC Evex Medical Corporation | Marina Dadunashvili | Georgia | Imeret'i | Tbilisi |
| David Tatishvili Medical Cente | Irakli Khmaladze | Georgia | Tbilisi | Tbilisi |
| LLC 'Vivamedi' | Mimoza Kankia | Georgia | T'bilisi | T'bilisi |
| LTD Central University Clinic | Rusudan Shonia | Georgia | T'bilisi | T'bilisi |
| JSC Infectious Disease | Tamara Megrelishvili | Georgia | T'bilisi | T'bilisi |
| LTD Aversi Clinic | Tengiz Telia | Georgia | T'bilisi | T'bilisi |
| JSC Evex Medical Corporation | Nana Bolkvadze | Georgia | Ajaria | Batumi |
| Clinical Cardiology Institute | Manana Giorgadze | Georgia | T'bilisi | T'bilisi |
| Synexus Leipzig Research Centr | Ekkehard Guertler | Germany | n/a | Leipzig |
| Synexus Clinical Research GmbH | Christel Contzen | Germany | n/a | Frankfurt-am-Main |
| Medius Clinic Nuertingen | Tanja Kuehbacher | Germany | Baden-Württemberg | Nuertingen |
| Ruppinen Hospital Ltd. | Karsten-Henrich Weylandt | Germany | Brandenburg | Neuruppin |
| Charite University Hospital | Christoph Jochum | Germany | Berlin | Berlin |
| Hospital Waldfriede e.V. | Carsten Buening | Germany | Berlin | Berlin |
| Charite University Hospital | Andreas Fischer | Germany | Berlin | Berlin |
| Univ. Hosp. Schleswig-Holstein | Stefan Schreiber | Germany | Schleswig-Holstein | Kiel |
| DRK Clinics Berlin | Andreas Sturm | Germany | Berlin | Berlin |
| University Hospital Leipzig | Babett Holler | Germany | Sachsen | Leipzig |
| Charite Hospital Berlin | Britta Siegmund | Germany | Berlin | Berlin |
| Crohn Colitis Cent. Rhein Main | Juergen Stein | Germany | Hessen | Frankfurt-am-Main |
| Practice for Gastroenterology | Peter Uebel | Germany | Rheinland-Pfalz | Ludwigshafen am Rhein |
| University Hospital Halle (Saale) | Jens Walldorf | Germany | Sachsen-Anhalt | Halle |
| J W Goethe University Hospital | Irina Blumenstein | Germany | Hessen | Frankfurt-am-Main |
| Studiengesellschaft BSF | Lars Fechner | Germany | Saxony | Halle |
| Univ. Hosp. Hamburg-Eppendorf | Carolin Manthey | Germany | Hamburg | Hamburg |
| Agaplesion Markus Hospital | Axel Dignass | Germany | Hessen | Frankfurt-am-Main |
| University Hospital Ulm | Jochen Klaus | Germany | Baden-Württemberg | Ulm |
| Brandenburg City Hospital | Stefan Lueth | Germany | Brandenburg | Brandenburg an der Havel |
| University Hospital Tuebingen | Stefano Fusco | Germany | Baden-Württemberg | Tuebingen |
| University Hospital Muenster | Phil Tepasse | Germany | Nordrhein-Westfalen | Muenster |
| St.Marien-u. St.Annastifts-KH | Joerg Hoffmann | Germany | Rheinland-Pfalz | Ludwigshafen am Rhein |
| Medical Care Unit Dachau | Wilfred Landry | Germany | Bavaria | Dachau |
| Alexandra General Hospital | Spyrido Michopoulos | Greece | Attiki | Athens |
| Metropolitan General | Theodoros Emmanouil | Greece | n/a | Athens |
| Thessaloniki General Hospital | Ioannis Goulis | Greece | Thessaloniki | Thessaloniki |
| Queen Mary Hospital | Wai Keung Leung | 中国香港 | Hong Kong | n/a |
| SYNEXUS Hungary | Janos Novak | Hungary | n/a | Gyula |
| Synexus Hungary Ltd. | Alajos Takats | Hungary | n/a | Budapest |
| Bekescsaba Rethy Pal Hospital | Marta Varga | Hungary | Békés | Bekescsaba |
| Fejer County St. Gyorgy Unive | Roland Fejes | Hungary | Fejér | Szekesfehervar |
| Kanizsai Dorottya Hospital | Laszlo Barany | Hungary | Zala | Nagykanizsa |
| Petz Aladar County Hospital | Istvan Racz | Hungary | Gyr-Moson-Sopron | Gyor |
| Medical Centre, Defence Forces | Laszlo Herszenyi | Hungary | Budapest | Budapest |
| Semmelweis University | Zsolt Tulassay | Hungary | Pest | Budapest |
| Csongrad County Hospital | Barnabas Bod | Hungary | Csongrád | Szentes |
| Clinfan Ltd | Agnes Salamon | Hungary | Szekszárd | Szekszárd |
| Beaumont Hospital | Stephen Patchett | Ireland | Dublin | Dublin |
| St Vincent's University Hospital | Juliette Sheridan | Ireland | Dublin | Dublin |
| Kaplan Medical Center, GI and Liver Disease Institute | Bruce Mosenkis | Israel | N/A | Rehovot |
| Shaare Zedek Medical Center | Eran Goldin | Israel | N/A | Jerusalem |
| Gastroenterology Division, Rabin Medical Center, Beilinson Campus | Irit Avni-Biron | Israel | N/A | Petah-Tikva |
| Gastroenterology Department, Outpatient Clinics, unit 9Sheba Medical Center | Adi Lahat-Zok | Israel | N/A | Ramat Gan (Tel Hashomer) |
| IBD unit, Institute of Gastroenterology and Liver Diseases, Emek Medical Center | Eran Zittan | Israel | N/A | Afula |
| Meir Medical Center, Gastroenerology &HepatologyStulberg Building | Yehuda Ringel | Israel | N/A | Kfar Saba |
| Rambam Health Care Campus | Mattitiahu Waterman | Israel | Bat Galim | Haifa |
| Hospital S. Camillo Forlanini | Rocco Cosintino | Italy | Roma | Rome |
| Humanitas Research Hospital | Laura Loy | Italy | Milano | Milan |
| Polyclinic San Matteo, IRCCS | Antonio Di Sabatino | Italy | Lombardia | Pavia |
| G. Martino University Polyclinic Hospital | Walter Fries | Italy | Sicillia | Messina |
| Agostino Gemelli | Antonio Gasbarrini | Italy | Roma | Rome |
| Sacred Heart Don Calabria | Andrea Geccherle | Italy | Verona | Negrar |
| Polyclinic S. Orsola-Malpighi | Paolo Gionchetti | Italy | Bologna | Bologna |
| ASST Monza | Pietro Invernizzi | Italy | Monza e Brianza | Monza |
| Mater Domini | Francesco Luzza | Italy | Calabria | Catanzaro |
| Integrated University Hospital | Marco Marino | Italy | Udine | Udine |
| Hospitals Villa Sofia Cervello | Ambrogio Orlando | Italy | Palermo | Palermo |
| Civil Hospital of Brescia | Chiara Ricci | Italy | Brescia | Brescia |
| Hospital of Padova | Edoardo Savarino | Italy | Padova | Padova |
| Ss. Annunziata Policlinic of Chieti | Matteo Neri | Italy | Abruzzo | Chieti |
| Poliambulanza Hospital | Cristiano Spada | Italy | Brescia | Brescia |
| IRCCS Savario De Bellis | Mauro Mastronardi | Italy | Bari | Bari |
| Kangbuk Samsung Hospital | Dong II Park | Korea | N/A | Seoul |
| The Catholic University of Korea St.Vincents Hospital | Kang-Moon Lee | Korea | Gyeonggi-do | Suwon |
| Severance Hospital, Yonsei University Health System | Jae Hee Cheon | Korea | N/A | Seoul |
| InJe University Haeundae Paik Hospital | TaeOh Kim | Korea | N/A | Busan |
| Yeungnam University Hospital | Byung Ik Jang | Korea | N/A | Daegu |
| Samsung Medical Center | Young Ho Kim | Korea | N/A | Seoul |
| Hanyang University Guri Hospital | Dong Soo Han | Korea | N/A | Gyeonggi-do |
| Seoul National University Bundang Hospital | Young Soo Park | Korea | Gyeonggi-do | Seongnam-si |
| Seoul National University Hospital | JongPil Im | Korea | N/A | Seoul |
| Clinical Trial Center | Seong-Eun Kim | Korea | South Korea | Seoul |
| Dong-A Medical Center | Jonghun Lee | Korea | n/a | Busan |
| LLC Digestive Diseases Centre | Marcis Leja | Latvia | Rīga | Rīga |
| P Stradins Clinical University | Aldis Pukitis | Latvia | Rīga | Rīga |
| Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. | Roberto Ulises Cruz Neri | Mexico | Jalisco | Zapopan |
| Centro de Investigacion Clinica Acelerada (CICA) S.C. | Jose Gilberto Romero Lozano | Mexico | Mexico | Mexico |
| ICARO Investigaciones en Medicina S.A. de C.V. | Ramon Payan Olivas | Mexico | Chihuahua | Chihuahua |
| SMIQ | Claudio Marmolejo Garcia | Mexico | Queretaro | Queretaro |
| Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubiran ( INCMNSZ) | Jesus Katzuo Yamamoto-Furusho | Mexico | Ciudad de México | Tlalpan |
| Centro Regiomontano de Estudios Clinicos Roma | Azalia Ruiz | Mexico | Nuevo Leon | Monterrey |
| PMSI | Svetlana Turcan | Moldova | Chiinu | Chisinau |
| Sfanta Treime | Mihail Erlih | Moldova | Chiinu | Chisinau |
| Sf. Arhanghel Mihail Hospital | Valeriu Istrati | Moldova | Chiinu | Chisinau |
| PMSI | Tudor Timis | Moldova | Chiinu | Chisinau |
| Radboud Univ Medical Center | Willemijn van Dop | Netherlands | Gelderland | Nijmegen |
| Zuyderland Medical Center | Adriaan van Bodegraven | Netherlands | Limburg | Sittard |
| St. Elisabeth Hospital | Maurice Lutgens | Netherlands | Noord-Brabant | Tilburg |
| Academic Medical Center | Mark Lowenberg | Netherlands | n/a | Amsterdam |
| University Medical Center Groningen (UMCG) | Gerard Dijkstra | Netherlands | Groningen | Groningen |
| MDM Healthcare Centre | Marek Woynarowski | Poland | n/a | Warsaw |
| Synexus Polska Sp. z o.o. | Oleg Tyszkiwski | Poland | n/a | Poznan |
| Synexus Polska Sp. z o.o. | Michal Stepka | Poland | n/a | Warsaw |
| Synexus Polska Sp. z o.o. | Anna Orkwiszewska-Nalewajko | Poland | n/a | Gdynia |
| Synexus Polska Sp. z o.o. | Magdalena Olszanecka-Glinianowicz | Poland | n/a | Katowice |
| Synexus Polska Sp. z o.o. | Malgorzata Jagielska-Plata | Poland | n/a | Gdansk |
| Synexus Polska Sp. z o.o. | Zofia Jamrozik-Kruk | Poland | n/a | Czestochowa |
| Synexus Polska Sp. z o.o. | Mateusz Maciejewski | Poland | n/a | Lodz |
| Synexus Polska Sp. z o.o. | Agnieszka Ciesiolkiewicz-Wojcik | Poland | n/a | Wroclaw |
| WIP Warsaw IBD Point | Jaroslaw Kierkus | Poland | n/a | Warsaw |
| BioVirtus Medical Centre | Maria Orzeszko | Poland | Malopolska | Jozefow |
| SOLUMED Medical Center | Marek Karczewski | Poland | Wielkopolskie | Poznan |
| 1st Military Teaching Hospital | Przemyslaw Zajac | Poland | Maopolskie | Lublin |
| GLOBE Clinical Research | Rafal Dzygora | Poland | n/a | Klodzko |
| MaxMed Medical Services Centre | Bernadeta Gogola-Migdal | Poland | Maopolskie | Bochnia |
| Kornel Gibinski Hospital | Marek Hartleb | Poland | lskie | Katowice |
| Jedrzej Sniadecki Hospitals | Agnieszka Janke | Poland | Podlaskie | Bialystok |
| Landa Specialist Doctor's Of | Katarzyna Landa | Poland | Maopolskie | Krakow |
| H-T Medical Center Endotherapy | Tomasz Romanczyk | Poland | lskie | Tychy |
| Krakow Medical Center, LLC | Piotr Rozpondek | Poland | Maopolskie | Krakow |
| ETG Kielce Zagorska | Dariusz Solowiej | Poland | witokrzyskie | Kielce |
| SANTA FAMILIA Research | Maria Wisniewska-Jarosinska | Poland | ódzkie | Lodz |
| Provincial Specialist Hospital | Tomasz Arlukowicz | Poland | Warmińsko-mazurskie | Olsztyn |
| LEXMEDICA | Jerzy Rozciecha | Poland | Wroclaw | Wroclaw |
| EuroMediCare | Bernardeta Frysna | Poland | Wroclaw | Wroclaw |
| Orkan-Med Healthcare Centre | Krystyna Stec-Michalska | Poland | ódzkie | Ksawerow |
| TWOJA PRZYCHODNIA | Beata Gawdis-Wojnarska | Poland | Pomorze Przednie | Szczecin |
| Salve Limited Company | Justyna Kotynia | Poland | ódzkie | Lodz |
| Metabolic Diseases Clinic | Robert Witek | Poland | n/a | Wierzchoslawice |
| Private Medical Practice M.Fic | Miroslaw Fic | Poland | Dolnolskie | Jelenia Gora |
| Office of Korczowski Bartosz | Bartosz Korczowski | Poland | Podkarpackie | Rzeszow |
| Allmedica Clinical Trials | Mikolaj Krzyzanowski | Poland | Maopolskie | Nowy Targ |
| D.Kleczkowski Medical Practice | Marek Horynski | Poland | Pomorskie | Sopot |
| Clinical Research Center | Piotr Napora | Poland | Wroclaw | Wroclaw |
| LUX MED Sp. z o.o. (LLC) | Pawel Petryszyn | Poland | Wroclaw | Wroclaw |
| Jan Mikulicz Radecki University Hospital in Wroclaw | Elzbieta Poniewierka | Poland | Dolnoslaskie | Wroclaw |
| PlanetMed Gastroenterology | Barbara Wozniak-Stolarska | Poland | Dolny Slask | Wroclaw |
| St. John Paul 2nd Hospital | Krzysztof Niezgoda | Poland | Warmińsko-mazurskie | Elblag |
| Local Unit of Health Alto Minh | Luis Miguel da Silva Araujo Lopes | Portugal | Viana do Castelo | Viana do Castelo |
| Univ Hospital Center Coimbra | Francisco Portela | Portugal | Coimbra | Coimbra |
| Hospital Beatriz Angelo | Joana Torres | Portugal | Lisboa | Loures |
| Provita Center of Diagnosis | Marieta Madalina Florescu | Romania | Bucharest | Bucharest |
| Hyperclinic MedLife Grivita | Ion-Eugeniu Craciun | Romania | Bucharest | Bucharest |
| Hyperclinic MedLife Grivita | Nicoleta Claudia Cimpoeru | Romania | Bucharest | Bucharest |
| Fundeni Clinical Institute | Liliana Simona Gheorghe | Romania | Bucharest | Bucureti |
| Colentina Clinical Hospital | Radu Bogdan Mateescu | Romania | Bucharest | Bucharest |
| University Emergency Hospital | Lucian Negreanu | Romania | Bucharest | Bucharest |
| Targu Mures County Hospital | Maria Simona Bataga | Romania | Mures | Targu Mures |
| Carol Davila Military Hospital | Mariana Jinga | Romania | Bucuresti | Bucharest |
| OLLA MED, LLC | Pavel Makarchuk | Russia | Moskva | Moscow |
| Medical Technologies | Marina Karakina | Russia | Sverdlovskaya oblast | Ekaterinburg |
| Myod Ltd | Nadezhda Temnikova | Russia | Rostovskaya oblast | Bataisk |
| Novosibirskiy Gastrocentr | Ekaterina Valuyskikh | Russia | Novosibirskaya oblast | Novosibirsk |
| Chita State Medical Academy | Albina Zhilina | Russia | Zabajkal'skij kraj | Chita |
| Regional Clinical Hospital | Evgenia Sosnovskaya | Russia | n/a | Khanty-Mansiysk |
| Tula Clinical Hospital | Julia Troshkina | Russia | Tul'skaya oblast | Tula |
| Samara Station Railway Hospita | Pavel Andreev | Russia | Samarskaya oblast | Samara |
| Clinical and Diagnostic Center | Elena Avalueva | Russia | Leningradskaya oblast' | St. Petersburg |
| Pyatigorsk City Clinical Hospi | Elena Bardina | Russia | Stavropol'skiy kray | Pyatigorsk |
| Irkutsk State Medical Academy | Olga Fedorishina | Russia | Irkutskaya oblast' | Irkutsk |
| S.V. Beliaev Regional Hospital | Evgenia Gerasimova | Russia | Kemerovskaya oblast' | Kemerovo |
| Medical Center Sibnovomed, LLC | Marina Osipenko | Russia | Novosibirskaya oblast' | Novosibirsk |
| Novgorod Regional Clinical Hos | Andrey Abdulin | Russia | Novgorodskaya oblast' | Veliky Novgorod |
| St. Elizabeth Hospital | Yulia Fominykh | Russia | Leningradskaya oblast' | St. Petersburg |
| EVROMEDSERVIS Private Medical | Irina Shumikhina | Russia | Sankt-Peterburg | St. Petersburg |
| Kirov Military Medical Academy | Alexander Gordienko | Russia | Leningradskaya oblast' | St. Petersburg |
| I.I. Mechnikov State Univ. | Igor Bakulin | Russia | Sankt-Peterburg | St. Petersburg |
| Medical University | Elena Bunkova | Russia | Samarskaya oblast' | Samara |
| N.N. Burdenko Penza Hospital | Natalia Galkina | Russia | Penzenskaja oblast' | Penza |
| S.M. Kirov Military Medical Ac | Vladimir Grinevich | Russia | Sankt-Peterburg | St. Petersburg |
| Territorial Clinical Hospital | Olga Ovchinnikova | Russia | Altayskiy kray | Barnaul |
| MA | Elina Petrova | Russia | Sverdlovskaya oblast' | Ekaterinburg |
| City Clinical Hospital #31 | Oksana Shchukina | Russia | Leningradskaya oblast' | St. Petersburg |
| Medical Diagnostic Center, LLC | Oleg Mironchev | Russia | Orenburgskaja oblast' | Orenburg |
| Tomsk Regional Clinical Hospit | Evgenia Shepeleva | Russia | Tomskaya oblast' | Tomsk |
| Rostov State Medical Univ. | Alexey Yakovlev | Russia | Rostovskaya oblast' | Rostov-on-Don |
| Kazan City Clinical Hospital 7 | Dilyara Iskhakova | Russia | Tatarstan, Respublika | Kazan |
| Siberian Research Clin. Center | Viktoria Kashanskaya | Russia | Krasnoyarskiy kray | Krasnoyarsk |
| Regional Clinical Hospital | Olga Vasilyeva | Russia | Vladimirskaya oblast' | Vladimir |
| Clinic UZI 4D, LLC | Daria Saenko | Russia | Stavropol'skij kraj | Pyatigorsk |
| Diagnostic Center Bioterm Ltd. | Irina Belova | Russia | Altayskiy kray | Barnaul |
| Railway Station Hospital | Natalya Eremina | Russia | Novgorodskaya oblast' | Nizhny Novgorod |
| Chelyabinsk Regional Hospital | Olga Nesmeyanova | Russia | Chelyabinskaya oblast' | Chelyabinsk |
| Regional Clinical Hospital | Olga Reshetko | Russia | Saratovskaja oblast' | Saratov |
| City Outpatient Care Unit #38 | Boris Starostin | Russia | Leningradskaya oblast' | St. Petersburg |
| V.M. Buyanov City Hospital | Ilya Fedorov | Russia | Moskva | Moscow |
| Immanuel Kant Baltic Federal University | Vladimir Rafalskiy | Russia | Kaliningrad Oblast | Kaliningrad |
| Primorsky Reg. Hospital No 1 | Olga Chesnokova | Russia | Primorskiy kray | Vladivostok |
| King Abdulaziz Medical city, National guard hospital, Riyadh | Abdullah Al Jahdali | Saudi Arabia | Riyadh | NA |
| King Khalid University Hospital | Othman Al Harbi | Saudi Arabia | Riyadh | NA |
| King AbdulAziz University Hospital Jeddah | Mahmoud Mosli | Saudi Arabia | Jeddah | NA |
| General Hospital Vrsac | Vladan Petrovic | Serbia | n/a | Vrsac |
| Dr. Dragisa Misovic-Dedinje | Branka Filipovic | Serbia | n/a | Belgrade |
| General Hospital Pancevo | Tatjana Djorovic | Serbia | Vojvodina | Pancevo |
| Military Medical Academy | Radoje Doder | Serbia | Beograd | Belgrade |
| Bezanijska Kosa Hospital Cente | Igor Jovanovic | Serbia | Beograd | Belgrade |
| General Hospital | Tatjana Radakovic | Serbia | Vojvodina | Zrenjanin |
| Zvezdara UMC | Petar Svorcan | Serbia | Beograd | Belgrade |
| Clinical Center Kragujevac | Natasa Zdravkovic Petrovic | Serbia | Sumadijski okrug | Kragujevac |
| World of the Health Inc. | Jan Zachar | Slovakia | Banskobystricky kraj | Rimavska Sobota |
| Gastromedic, s.r.o. | Iveta Kalisova | Slovakia | Nitriansky kraj | Nove Zamky |
| GASTRO I, s.r.o. | Ivan Bunganic | Slovakia | Preovsky kraj | Presov |
| Cliniq, s.r.o. | Tibor Hlavaty | Slovakia | Bratislavsky kraj | Bratislava |
| General Hospital Celje | Renata Sibli | Slovenia | Celje | Celje |
| Emmed Research | Johannes Breedt | South Africa | Gauteng | Muckleneuk |
| Lenasia Clinical Trial Centre | Naeem Moosa | South Africa | Gauteng | Johannesburg |
| Clinresco Centres Jennifer Rosa | Jennifer Rosa | South Africa | Gauteng | Kempton Park |
| Germans Trias i Pujol Hospital | Eugenio Domenech Morral | Spain | Barcelona | Badalona |
| Univ. Hospital de La Princesa | Francisco Javier Perez Gisbert | Spain | Madrid, Comunidad de | Madrid |
| University Hospital La Paz | Maria Dolores Martin Arranz | Spain | Madrid | Madrid |
| Puerta de Hierro Majadajonda | Maria Isabel Vera Mendoza | Spain | Madrid, Comunidad de | Madrid |
| Teknon Medical Center | Miquel Dels Sant Sans Cuffi | Spain | Cataluna | Barcelona |
| HUC La Laguna | Laura Ramos | Spain | Canarias | Santa Cruz de Tenerife |
| Hospital of Girona Dr.J.Trueta | Xavier Aldeguer Mante | Spain | Catalunya | Girona |
| Viladecans Hospital | Antonia Perello Juan | Spain | Barcelona | Barcelona |
| Dr Negrin University Hospital | Daniel Ceballos Santos | Spain | Las Palmas | Las Palmas de Gran Canaria |
| Hospital Reina Sofia | Jose Manuel Benitez Cantero | Spain | Andalucía | Cordoba |
| University Hospital Alicante | Rodrigo Jover Martinez | Spain | Valenciana, Comunidad | Alicante |
| University Hospital Marques de Valdecilla (HUMV), Department of Gastroenterology | Montserrat Rivero Tirado | Spain | Cantabria | Santander |
| Lindenhofspital | Frank Seibold | Switzerland | Bern | Bern |
| Cantonal Hospital Saint Gallen | Stephan Brand | Switzerland | Sankt Gallen | St.Gallen |
| China Medical University Hospital | Jen-Wei Chou | 中国台湾 | N/A | Taichung City |
| National Cheng Kung University Hospital | Chiao-Hsiung Chuang | 中国台湾 | N/A | Tainan |
| Chang Gung Medical Hospital - LINKOU | Cheng-Tang Chiu | 中国台湾 | N/A | Taoyuan County |
| National Taiwan University Hospital | Chia-Hung Tu | 中国台湾 | N/A | Taipei |
| Goztepe Prof. Suleyman Yalcin | Celal Hak ULASOGLU | Turkey | Istanbul | Istanbul |
| Kocaeli University Medical Fac | Saadettin Hulagu | Turkey | Istanbul | Izmit/Kocaeli |
| Hacettepe üniversitesi Hastanesi | Taylan Kav | Turkey | Ankara | Ankara |
| Karadeniz Teknik üniversitesi Farabi Hastanesi | Murat Erkut | Turkey | Trabzon | Trabzon |
| Istanbul Sultanabdülhamit Han Egitim Arastirma Hastanesi | Yusuf Yazgan | Turkey | Istanbul | Istanbul |
| Bezmialem Vakif Universitesi Hastanesi | Hakan Senturk | Turkey | Istanbul | Istanbul |
| Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi | Selim Aydemir | Turkey | Zonguldak | Zonguldak |
| CENTER OF FAMILY MEDICINE PLUS | Liudmyla Chupryna | Ukraine | n/a | Kyiv |
| EDELWEISS MEDICS | Oleksandra Bilotkach | Ukraine | n/a | Kyiv |
| Medical Center within 'Medbud' | Dmytro Donets | Ukraine | n/a | Kyiv |
| Clinic of the St. Nicholas | Kostyantyn Mylytsya | Ukraine | Zaporiz'ka Oblast' | Zaporizhia |
| Volyn Regional Clin.Hospital | Oleh Tkachuk | Ukraine | Volyns'ka Oblast' | Lutsk |
| Kyiv City Clinical Hospital 18 | Tetiana Kravchenko | Ukraine | Kyiv | Kyiv |
| Odesa Regional Clin. Hospital | Andriy Yurkiv | Ukraine | Odes'ka Oblast' | Odesa |
| Poltava Sklifosovskyi Hospital | Igor Skrypnyk | Ukraine | Poltavs'ka Oblast' | Poltava |
| Kyiv Regional Clinical Hospita | Tetiana Budko | Ukraine | Kyiv | Kyiv |
| Vinnytsia City Clinical Hosp 1 | Halyna Tomashkevych | Ukraine | Vinnyts'ka Oblast' | Vinnytsia |
| Ok! Clinic | Svitlana Skybalo | Ukraine | Kyiv | Kyiv |
| Ivano-Frankivsk Central Hospit | Vasyl Neiko | Ukraine | Ivano-Frankivs'ka Oblast' | Ivano-Frankivsk |
| Chernivtsi Regional Hospital | Oleksandr Fediv | Ukraine | Chernivets'ka Oblast' | Chernivtsi |
| Consylium Medical Center | Oksana Gerasymenko | Ukraine | Kyiv | Kyiv |
| Kyiv Regional Hospital #2 | Tetiana Lohdanidi | Ukraine | Kyiv | Kyiv |
| Khmelnytskyi Regional Hospital | Vitalii Balytskyi | Ukraine | Khmel'nyts'ka Oblast' | Khmelnytskyi |
| Vinnytsia M.I.Pyrohov Hospital | Mykola Stanislavchuk | Ukraine | Vinnyts'ka Oblast' | Vinnytsia |
| Zaporizhia Regional Hospital | Serhii Svystun | Ukraine | Zaporiz'ka Oblast' | Zaporizhia |
| Ivano-Frankivsk Reg. Hospital | Ihor Zbyrak | Ukraine | Ivano-Frankivs'ka Oblast' | Ivano-Frankivsk |
| Health Clinic, LLC | Oleksandr Golovchenko | Ukraine | Vinnyts'ka Oblast' | Vinnytsia |
| Medical Center | Viktoriia Shevchuk | Ukraine | Kirovohrads'ka Oblast' | Kropyvnytskyi |
| Institute of Gastroenterology | Ihor Budzak | Ukraine | Dnipropetrovs'ka Oblast' | Dnipro |
| O.O. Shalimov City Hospital #2 | Oleksii Datsenko | Ukraine | Kharkivs'ka Oblast' | Kharkiv |
| M.I. Pyrohov Regional Hospital | Natalia Kizlova | Ukraine | Vinnyts'ka Oblast' | Vinnytsia |
| Lviv Regional Clinical Hospita | Yaroslav Zborivskyy | Ukraine | L'vivs'ka Oblast' | Lviv |
| Kyiv Regional Clinical Hospita | Volodymyr Pirohovskyi | Ukraine | Kyiv | Kyiv |
| Synexus Midlands Clin Centre | Karen Faulkner | United Kingdom | Birmingham | Birmingham |
| Synexus Hexham Research Centre | Shalini Iyengar | United Kingdom | n/a | Hexham |
| Synexus Wales CRC | Nimal Balaratnam | United Kingdom | n/a | Cardiff |
| Royal Shrewsbury Hospital | Jeff Butterworth | United Kingdom | n/a | Shrewsbury |
| Guy's Hospital | Mark Samaan | United Kingdom | London | London |
| Blackpool Victoria Hospital | Rhys Butcher | United Kingdom | Lancashire | Blackpool |
| Royal London Hospital | Gareth Parkes | United Kingdom | London | London |
| Southampton General Hospital | James Rowland Fraser Cummings | United Kingdom | Hampshire | Southampton |
| University College Hospital | Ioanna Parisi | United Kingdom | London | London |
| IMIC, Inc. | Miguel Rodriguez | United States | Florida | Palmetto Bay |
| Medical Associates Research Group | Hyun Kim | United States | California | San Diego |
| Henry Ford Health System | Nirmal Kaur | United States | Michigan | Novi |
| Inland Empire Liver Foundation | Zeid Kayali | United States | California | Rialto |
| Mayo Clinic Health System - Franciscan Healthcare | Michael Van Norstrand | United States | Wisconsin | La Crosse |
| Gleason Research, LLC | Gary Gleason | United States | Wisconsin | Spokane |
| Blue Ridge Medical Research | Larry Clark | United States | Virginia | Lynchburg |
| McGuire DVAMC | William Pandak | United States | Virginia | Richmond |
| Carilion Clinic | Maithili Chitnavis | United States | Virginia | Roanoke |
| The University of Utah Health Sciences Center | Jessica Johnson | United States | Utah | Salt Lake City |
| Texas Digestive Disease Consultants | Timothy Ritter | United States | Texas | Southlake |
| Brooke Army Medical Center | John Gancayco | United States | Texas | Fort Sam Houston |
| Houston Methodist | Bincy Abraham | United States | Texas | Houston |
| DHAT Research Institute | Harry Sarles | United States | Texas | Garland |
| Tyler Research Institute | George Duvall | United States | Texas | Tyler |
| Sun Research Institute | Carl Dukes | United States | Texas | San Antonio |
| Baylor College of Medicine | Jason Hou | United States | Texas | Houston |
| Avant Research Associates, LLC | Rajesh Mehta | United States | Texas | Austin |
| San Antonio Gastroenterology Associates Clinical Trials (SAGACT) | Jeff Bullock | United States | Texas | San Antonio |
| Baylor Scott & White | Christopher Johnson | United States | Texas | Temple |
| The Coastal Medical Group | Rukan Daccak | United States | Texas | Houston |
| Gastroenterology Associates of Orangeburg | Narayanachar Murali | United States | South Carolina | Orangeburg |
| Medical Univ of S Carolina | Erin Forster | United States | South Carolina | Charleston |
| Penn State Milton S Hershey Medical Center | Kofi Clarke | United States | Pennsylvania | Hershey |
| Oregon Health and Science University | Nir Modiano | United States | Oregon | Portland |
| Central Sooner Research | Elise Wiesner | United States | Oklahoma | Norman |
| Digestive Disease Specialists Inc | David Stokesberry | United States | Oklahoma | Oklahoma City |
| Vital Prospects Clinical Research Institute, PC | Iftikhar Hussain | United States | Oklahoma | Tulsa |
| Richard Harty | Richard Harty | United States | Oklahoma | Oklahoma City |
| Essential Medical Research, LL | Aaron Fieker | United States | Oklahoma | Tulsa |
| Cleveland Clinic | Bret Lashner | United States | Ohio | Cleveland |
| The Ohio State University Wexner Medical Center | Anita Afzali | United States | Ohio | Columbus |
| Advance Clinical Research | Ugo Nwokoro | United States | Ohio | Dayton |
| Advance Clinical Research | Matthew Atkinson | United States | Ohio | Cincinnati |
| PMG Research of Winston-Salem, LLC | Robert Holmes | United States | North Carolina | Winston-Salem |
| Carolina Research/Carolina Digestive Diseases | Phillip Goldstein | United States | North Carolina | Greenville |
| CHS - Center for Digestive Health | John Hanson | United States | North Carolina | Charlotte |
| PMG Research of Charlotte, LLC | Fred Fowler | United States | North Carolina | Charlotte |
| Northwell Health | Keith Sultan | United States | New York | Great Neck |
| Lenox Hill Hospital - Northwell Health | Arun Swaminath | United States | New York | New York |
| Drug Trials America | Michael Gerdis | United States | New York | Hartsdale |
| DiGiovanna Institute for Medical Education and Research | Michael DiGiovanna | United States | New York | North Massapequa |
| Weill Cornell Medicine | Randy Longman | United States | New York | New York |
| NY Scientific/Igor Grosman | Igor Grosman | United States | New York | Brooklyn |
| Dartmouth-Hitchcock Medical Center | Corey Siegel | United States | New Hampshire | Lebanon |
| Washington University School of Medicine | Parakkal Deepak | United States | Missouri | St. Louis |
| Mid America Gastrointestinal Consultants | Hillary Bownik | United States | Missouri | Kansas City |
| Southern Therapy and Advanced Research | Brian Borg | United States | Mississippi | Jackson |
| Mayo Clinic | Edward Loftus | United States | Minnesota | Rochester |
| University of Minnesota | Eugenia Shmidt | United States | Minnesota | Minneapolis |
| Revival Research Institute LLC | Alan Cutler | United States | Michigan | Farmington Hills |
| Western Michigan University Homer Stryker M.D. School fo Medicine | Brij Dewan | United States | Michigan | Kalamazoo |
| Caro Health Plaza | Naveed Mahfooz | United States | Michigan | Saginaw |
| University of Massachusetts Memorial Medical Center | David Cave | United States | Massachusetts | Worcester |
| Brigham and Women's Hospital | Jessica Allegretti | United States | Massachusetts | Boston |
| Digestive Disease Associates, PA | Vijay Narayen | United States | Maryland | Catonsville |
| Woodholme Gastroenterology Associates | Kenolisa Onwueme | United States | Maryland | Glen Burnie |
| Gastroenterology Associates, LLC | Jonathon Chapman | United States | Louisiana | Baton Rouge |
| University of Kentucky Chandler Medical Center | Deborah Flomenhoft | United States | Kentucky | Lexington |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Curtis Baum | United States | Kansas | Topeka |
| Indiana University Hospital | Monika Fischer | United States | Indiana | Indianapolis |
| Medisphere Medical Research Center, LLC | Hubert Reyes | United States | Indiana | Evansville |
| University of Chicago Medicine | Russell Cohen | United States | Illinois | Chicago |
| Northwestern Feinberg School of Medicine | Stephen Hanauer | United States | Illinois | Chicago |
| Rush University Medical Center - University Cardiovascular Surgeons | Ioannis Economou | United States | Illinois | Chicago |
| Grand Teton Research Group, PLLC | Paul Hendrix | United States | Idaho | Idaho Falls |
| Atlanta Gastroenterology Associates | Douglas Wolf | United States | Georgia | Atlanta |
| Gastroenterology Associates of Central Georgia | Shahriar Sedghi | United States | Georgia | Macon |
| Emory University | Heba Iskandar | United States | Georgia | Atlanta |
| Children's Center for Digestive Health Care | Jeffery Lewis | United States | Georgia | Atlanta |
| Southwest Gastroenterology | Kamran Ayub | United States | Oak Lawn | Oak Lawn |
| Gastrointestinal Disease Research | Shankar Thiruppathi | United States | Georgia | Columbus |
| Atlanta Center for Gastroenterology, P.C. | David Rausher | United States | Georgia | Decatur |
| Consultative Gastroenterology | Gary Richter | United States | Georgia | Atlanta |
| Florida Center for Gastroenterology | Steven Beljic | United States | Florida | Largo |
| Galiz Research | Jose Gamez | United States | Florida | Hialeah |
| Gastroenterology Consultants of Clearwater | L. Michael Weiss | United States | Florida | Clearwater |
| Alliance Medical Research LLC | Vipin Gupta | United States | Florida | Lighthouse Point |
| HMD Research LLC | Marvin Heuer | United States | Florida | Orlando |
| Advanced Medical Research Center | Ammar Hemaidan | United States | Florida | Port Orange |
| Guardian Angel Research | Angel Rosario | United States | Florida | Tampa |
| Universal Axon Clinical Research | Luis Martinez | United States | Florida | Doral |
| Research Associates of South Florida | Javier Sobrado | United States | Florida | Miami |
| Life Medical Center & Research, Inc | Armando De Feria | United States | Florida | Miami |
| The Center for Gastrointestinal Disorders | Mark Lamet | United States | Florida | Hollywood |
| University of South Florida | Jorge Marcet | United States | Florida | Tampa |
| Bayside Clinical Research | Tatiana Hernandez | United States | Florida | New Port Richey |
| Nova Clinical Research Center Inc | Amado Viera | United States | Florida | Miami |
| Omega Research Maitland | Kwabena Ayesu | United States | Florida | Orlando |
| Qway Research LLC | Miguel Chamah | United States | Hialeah | Florida |
| NSB Research | Bryan Heath | United States | New Smyrna Beach | Florida |
| University of Florida Health (UF) | Angela Pham | United States | Gainesville | Florida |
| Yale University - Digestive Disease | Deborah Proctor | United States | Connecticut | New Haven |
| Connecticut Clinical Research Institute | Salam Zakko | United States | Connecticut | Bristol |
| Peak Gastroenterology Associates | Bhaktasharan Patel | United StatesUnited States | Colorado | Colorado Springs |
| OM Research LLC | Jatinder Pruthi | United States | California | Lancaster |
| VVCRD Clinical Research | Michael Kurtz | United States | California | Garden Grove |
| University of Southern California | Sarah Sheibani | United States | California | Los Angeles |
| Gastrointestinal Biosciences | Nicholas Karyotakis | United States | California | Los Angeles |
| Sharp Chula Vista Medical Center | Errol Korn | United States | California | Chula Vista |
| University of California, Davis | Eric Mao | United States | California | Sacramento |
| University of California San Francisco | Melvin Heyman | United States | California | San Francisco |
| Arkansas Gastroenterology, P.A. | Scott Wofford | United States | Arkansas | North Little Rock |
| HonorHealth Research Institute | Akshay Shah | United States | Arizona | Scottsdale |
| 常州市第二人民医院 | 刘文佳 | 中国 | 江苏省 | 常州市 |
| 苏州大学附属第二医院 | 唐文 | 中国 | 江苏省 | 苏州市 |
| 江苏大学附属医院 | 徐岷 | 中国 | 江苏省 | 镇江市 |
| 温州医科大学附属第二医院 | 蒋益 | 中国 | 浙江省 | 温州市 |
| 中国医科大学附属盛京医院 | 郑长青 | 中国 | 辽宁省 | 沈阳市 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2020-07-23 |
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2021-05-10 |
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2022-01-19 |
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2023-06-08 |
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2023-07-21 |
| 浙江大学医学院附属邵逸夫医院医学伦理委员会 | 同意 | 2024-03-15 |
试验状态信息
试验状态
主动终止
目标入组人数
国内: 60 ；
国际: 550 ；
已入组例数
国内: 22 ；
国际: 551 ；
实际入组总例数
国内: 22 ；
国际: 551 ；
第一例受试者签署知情同意书日期
国内：2022-02-15；
国际：2018-06-27；
第一例受试者入组日期
国内：2022-02-15；
国际：2018-06-27；
试验终止日期
国内：2024-06-03；
国际：2024-06-03；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
