基本信息
| 登记号 | CTR20211116 | 试验状态 | 进行中 |
|---|---|---|---|
| 申请人联系人 | 周平 | 首次公示信息日期 | 2021-05-24 |
| 申请人名称 | Celgene International II Sarl/ Patheon, Inc./ 新基医药咨询（上海）有限公司 | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20211116 | ||
|---|---|---|---|
| 相关登记号 | CTR20211113,CTR20211103 | ||
| 药物名称 | Ozanimod胶囊 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 | ||
| 试验专业题目 | 一项评估口服Ozanimod 治疗中度至重度活动性克罗恩病的3期、多中心、开放标签、扩展研究 | ||
| 试验通俗题目 | 一项评估口服Ozanimod 治疗中度至重度活动性克罗恩病的扩展研究 | ||
| 试验方案编号 | RPC01-3204 | 方案最新版本号 | Amendment6.0 |
| 版本日期: | 2023-03-16 | 方案是否为联合用药 | 否 |
二、申请人信息
| 申请人名称 | 1 2 3 | ||||
|---|---|---|---|---|---|
| 联系人姓名 | 周平 | 联系人座机 | 请联系泰必达 | 联系人手机号 | 请联系泰必达 |
| 联系人Email | 请联系泰必达 | 联系人邮政地址 | 上海市-上海市-上海市静安区南京西路1717号会德丰大厦15楼 | 联系人邮编 | 200040 |
三、临床试验信息
1、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
2、试验设计
| 试验分类 | 安全性和有效性 | 试验分期 | III期 | 设计类型 | 单臂试验 |
|---|---|---|---|---|---|
| 随机化 | 非随机化 | 盲法 | 开放 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 年龄 | 18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 | 1 完成诱导研究RPC01-3201和/或RPC01-3202中12周治疗后没有临床应答或临床缓解的受试者、维持研究RPC01-3203中出现复发的受试者、完成维持研究RPC01-3203的受试者、完成RPC01-2201至少1年的受试者 2 在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。 3 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。不应同时使用女用避孕套和男用避孕套。 必须对FCBP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天对所有生育能力的女性(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。在女性受试者开始研究之时，女性受试者选择的避孕方式必须有效（例如激素避孕应在第1天之前至少28天开始）。 | ||
| 排除标准 | 1 受试者患有任何有临床意义的心血管（参见第6.1.1节）、肝脏、神经、肺[严重呼吸道疾病（肺纤维化或慢性阻塞性肺疾病）]、眼科、内分泌、精神疾病或其他重大全身性疾病，使得实施或理解方案产生困难或研究受试者面临风险。 2 受试者自既往ozanimod研究中IP首次给药后接受了以下任何治疗： 生物制剂治疗以及其他CD治疗，例如etrasimod、filgotinib、upadacitinib 除ozanimod以外的研究性药物治疗 应用D-青霉胺、来氟米特、沙利度胺、那他珠单抗、芬戈莫德治疗或其他S1P调节剂 淋巴细胞清除疗法（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、阿仑单抗或达利珠单抗）。 3 受试者正在接受以下任何药物治疗或干预措施： CYP2C8诱导剂（例如：利福平） 单胺氧化酶抑制剂（例如：司来吉兰，苯乙肼） 4 受试者妊娠、哺乳或尿液β人绒毛膜促性腺激素（β-hCG）检查阳性 5 受试者有疑似或确诊的腹腔或肛周脓肿，未给予适当治疗 6 对ozanimod或安慰剂的活性成分或辅料超敏 7 受试者正在接受或需要开始以下任何治疗： 糖皮质激素治疗（剂量超过泼尼松等效剂量> 40 mg） 免疫调节剂治疗（例如AZA、6-MP或MTX） 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治疗[例如，头痛、关节炎、肌痛或痛经]，和阿司匹林，最高325 mg/天）。 应用Ia类或III类抗心律失常药物治疗或联合使用两种或两种以上已知延长PR间期的药物（参见第8.2.1节）。 用乳腺癌耐药蛋白（BCRP）抑制剂（如环孢菌素，艾曲波帕）治疗。 8 受试者存在研究者认为会使受试者面临风险的任何有临床意义的ECG异常 9 受试者给药前静息HR<55bpm。第1天访视时允许进行一次复查。如果HR在第1天仍然<55bpm，则从之前的研究转入本研究的可用窗口期内，允许以后再进行一次复查。 | ||
4、试验分组
| 试验药 | 序号 名称 用法 1 中文通用名:Ozanimod 英文通用名:Ozanimod 商品名称:Ozanimod 剂型:胶囊剂 规格:0.23mg, 0.92mg 用法用量:给药途径：口服 剂量：0.92mg 给药频率： 每日一次 用药时程:234周 |
|---|---|
| 对照药 | 序号 名称 用法 暂未填写此信息 |
5、终点指标
| 主要终点指标及评价时间 | 序号 指标 评价时间 终点指标选择 1 CDAI 评分< 150的受试者比例 每52周，最长234周 有效性指标 2 SES-CD较基线降低≥50%的受试者比例 每52周，最长234周 有效性指标 3 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 每52周，最长234周 有效性指标 4 CDAI较基线降低≥100分或CDAI评分<150的受试者比例 每52周，最长234周 有效性指标 5 没有溃疡≥0.5cm且没有任何溃疡表面≥10%肠道节段的受试者比例 每52周，最长234周 有效性指标 6 CDAI较基线减少≥70分的受试者比例 每52周，最长234周 有效性指标 7 CDAI较基线的改变 每52周，最长234周 有效性指标 8 CDAI较基线减少≥100分或CDAI评分<150且SES-CD较基线降低≥50%的受试者比例 每52周，最长234周 有效性指标 9 CDAI评分<150且SES-CD≤4分和SES -CD降低≥2分的受试者比例 每52周，最长234周 有效性指标 10 平均每日腹痛评分≤1分、平均每日排便次数≤3分、腹痛和排便次数相对于基线没有恶化，以及SES-CD≤4分且SES-CD降低≥2分的受试者比例 每52周，最长234周 有效性指标 11 SES-CD≤4分和SES-CD降低≥2分的受试者比例 每52周，最长234周 有效性指标 12 糖皮质激素停药受试者中CDAI评分<150的受试者比例 每52周，最长234周 有效性指标 13 克罗恩病内镜检查严重程度指数（CDEIS）较基线降低≥50%的受试者比例 每52周，最长234周 有效性指标 |
|---|---|
| 次要终点指标及评价时间 | 序号 指标 评价时间 终点指标选择 暂未填写此信息 |
6、数据安全监查委员会（DMC）
有
7、为受试者购买试验伤害保险
有
四、研究者信息
1、主要研究者信息
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家或地区 | 省（州） | 城市 |
|---|---|---|---|---|---|
| 1 | 浙江大学医学院附属邵逸夫医院 | 曹倩 | 中国 | 浙江省 | 杭州市 |
| 2 | 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 |
| 3 | 广州市第一人民医院 | 聂玉强 | 中国 | 广东省 | 广州市 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 南昌大学第一附属医院 | 陈幼祥 | 中国 | 江西省 | 南昌市 |
| 9 | 安徽省立医院 | 解丽 | 中国 | 安徽省 | 合肥市 |
| 10 | 上海市东方医院 | 钟岚 | 中国 | 上海市 | 上海市 |
| 11 | 郑州大学第二附属医院 | 冯百岁 | 中国 | 河南省 | 郑州市 |
| 12 | 天津医科大学总医院 | 王邦茂 | 中国 | 天津市 | 天津市 |
| 13 | 昆明医科大学第一附属医院 | 李红缨 | 中国 | 云南省 | 昆明市 |
| 14 | 东南大学附属中大医院 | 施瑞华 | 中国 | 江苏省 | 南京市 |
| 15 | 吉林大学中日联谊医院 | 王江滨 | 中国 | 吉林省 | 吉林市 |
| 16 | 中南大学湘雅二医院 | 刘德良 | 中国 | 湖南省 | 长沙市 |
| 17 | 上海市第一人民医院 | 陆伦根 | 中国 | 上海市 | 上海市 |
| 18 | 蚌埠医学院第一附属医院 | 王启之 | 中国 | 安徽省 | 蚌埠市 |
| 19 | 复旦大学附属华山医院 | 戎兰 | 中国 | 上海市 | 上海市 |
| 20 | 无锡市人民医院 | 占强 | 中国 | 江苏省 | 无锡市 |
| 21 | 北京大学第三医院 | 丁士刚 | 中国 | 北京市 | 北京市 |
| 22 | 西南医科大学附属医院 | 邓明明 | 中国 | 四川省 | 泸州市 |
| 23 | 常州市第一人民医院 | 王玫 | 中国 | 江苏省 | 常州市 |
| 24 | 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 |
| 25 | 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 |
| 26 | 长海医院 | 杜奕奇 | 中国 | 上海市 | 上海市 |
| 27 | 南京鼓楼医院 | 于成功 | 中国 | 江苏省 | 南京市 |
| 28 | 四川大学华西医院 | 王玉芳 | 中国 | 四川省 | 成都市 |
| 29 | 西安国际医学中心 | 张方信 | 中国 | 陕西省 | 西安市 |
| 30 | 中南大学湘雅医院 | 徐美华 | 中国 | 湖南省 | 长沙市 |
| 31 | 福建医科大学附属第一医院 | 王承党 | 中国 | 福建省 | 福州市 |
| 32 | 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 |
| 33 | 广东省人民医院 | 沙卫红 | 中国 | 广东省 | 广州市 |
| 34 | Sanatorio 9 de Julio S.A.-CICE 9 de Julio | Abel Novillo | Argentina | Tucuman | San Miguel de Tucuman |
| 35 | Hospital Privado Centro Médico de Cordoba | Domingo Balderramo | Argentina | N/A | Córdoba |
| 36 | Hospital Provincial del Centenario | Orlando Ruffinengo | Argentina | Santa Fe | Rosario |
| 37 | CER Medical Institute-Quilmes | Edgardo Gimenez | Argentina | N/A | Quilmes |
| 38 | Diagnostic&Therap-ic Gastro-gy | Silvina Goncalves | Argentina | n/a | Buenos Aires |
| 39 | Alfred Hospital | Miles Sparrow | Australia | n/a | Melbourne |
| 40 | Liverpool Hospital | Susan Connor | Australia | New South Wales | Liverpool |
| 41 | Concord Repatriation General Hosptial | Rupert Leong | Australia | New South Wales | Concord |
| 42 | John Hunter Hospital | Lay Gan | Australia | New South Wales | New Lambton |
| 43 | Nepean Hospital | Jeff Chang | Australia | New South Wales | Kingswood |
| 44 | Wollongong Hospital | Thomas Lee | Australia | NSW | Wollongong |
| 45 | Princesss Alexandra Hospital | Gerald Holtmann | Australia | Queensland | Woolloongabba |
| 46 | Mater Hospital Brisbane | Jakob Begun | Australia | Queensland | South Brishane |
| 47 | Coastal Digestive Health Pty L | Hansjoerg Seltenreich | Australia | Queensland | Maroorchydore |
| 48 | Zuellig Pharma SSG Australia | Reme Mountifield | Australia | South Australia | Bedford park |
| 49 | Royal Adelaide Hospital | Vinh-An Phan | Australia | South Australia | Adelaide |
| 50 | Queen Elizabeth Hospital | James Fon | Australia | South Australia | Woodville |
| 51 | St Vincent's Hospital Melbourne | John Nik Ding | Australia | Victoria | Fitzroy |
| 52 | Monash Health | Gregory Moore | Australia | Victoria | Clayton |
| 53 | Medical University Vienna | Walter Reinisch | Austria | Wien | Vienna |
| 54 | University Hospital Innsbruck | Robert Koch | Austria | Tirol | Innsbruck |
| 55 | University Hospital St.Poelten | Andreas Mayer | Austria | Niedersterreich | St. Poelten |
| 56 | Vitebsk Regional Center | Henadz Yupatau | Belarus | Vitebskaya oblast' | Vitebsk |
| 57 | Grodno City Hospital #4 | Elena Bozhko | Belarus | Grodnenskaja oblast' | Grodno |
| 58 | Clinique du Montlégia | Arnaud Colard | Belgium | Liege | Liege |
| 59 | Sart Tilman Hospital, Department of Gastroenterology and Hepatology | Edouard Louis | Belgium | Liege | Liege |
| 60 | University Hospital Antwerp (UZA) | Elisabeth Macken | Belgium | Antwerp | Edegem |
| 61 | University Hospital Brussels | Liv Vandermeulen | Belgium | Brussels Hoofdstedelijk Gewest | Brussels |
| 62 | University Hospitals Leuven | Severine Vermeire | Belgium | Vlaams Brabant | Leuven |
| 63 | University Clinical Centre of | Stevan Trbojevic | Bosnia and Herzegovina | Republika Srpska | Banja Luka |
| 64 | Medical Center Synexus Sofia | Mariana Radicheva | Bulgaria | n/a | Stara Zagora |
| 65 | Medical Center Synexus Sofia | Veselin Kolchakov | Bulgaria | n/a | Sofia |
| 66 | Medline Multiprofile Hospital | Apostol Georgiev | Bulgaria | Plovdiv | Plovdiv |
| 67 | ACIBADEM City Clinic | Asen Petrov | Bulgaria | Sofia-Grad | Sofia |
| 68 | Sveti Ivan Rilski Hospital | Zoia Spassova | Bulgaria | Sofia-Grad | Sofia |
| 69 | ACIBADEM City Clinic Tokuda Ho | Simeon Stoynov | Bulgaria | Sofia-Grad | Sofia |
| 70 | Tsaritsa Yoanna ISUL Hospital | Plamen Penchev | Bulgaria | Sofia | Sofia |
| 71 | Kanev University Hospital | Galina Vasileva | Bulgaria | Ruse | Ruse |
| 72 | LHSC - Victoria Hospital | Terry Ponich | Canada | Ontario | London |
| 73 | London Health Sciences Centre - University Hospital | Vipul Jairath | Canada | Ontario | London |
| 74 | Brandon Medical Arts Clinic | Sonny Dhalla | Canada | Manitoba | Brandon |
| 75 | Kensington Screening Clinic | Ian Bookman | Canada | Ontario | Toronto |
| 76 | Fraser Clinical Trials, Inc | Kenneth Atkinson | Canada | British Columbia | New Westminster |
| 77 | Mount Sinai Hospital | Hillary Steinhart | Canada | Ontario | Toronto |
| 78 | G.I. Research Institute (G.I.R.I.) | Yvette Leung | Canada | British Columbia | Vancouver |
| 79 | Allen Lim Professional Corp | Allen Lim | Canada | Alberta | Edmonton |
| 80 | The Ottawa Hospital - General Campus | Richmond Sy | Canada | Ontario | Ottawa |
| 81 | Toronto Digestive Disease Associates Inc | Michael Gould | Canada | Ontario | Vaughan |
| 82 | University of Calgary | Remo Panaccione | Canada | Alberta | Calgary |
| 83 | CECIM | Elizabeth Arriagada Hernandez | Chile | n/a | Santiago |
| 84 | De La Costa Clinic Ltd. | Leonardo Brochado Fontalvo | Colombia | Atlantico | Barranquilla |
| 85 | University Hospital Zagreb | Zeljko Krznaric | Croatia | Zagrebacka zupanija | Zagreb |
| 86 | Military Hospital Brno | David Stepek | Czech Republic | Brno-venkov | Brno |
| 87 | Hepato-Gastroenterology HK s.r | Tomas Vanasek | Czech Republic | Hradec Kralove | Hradec Kralove |
| 88 | St. Anne's University Hospital | Jan Ulbrych | Czech Republic | Jihomoravsky kraj | Brno |
| 89 | Gastroenterology and Endoscopy | Vlastimil Woznica | Czech Republic | Most | Most |
| 90 | Synexus Czech s.r.o. | Vaclav Smid | Czech Republic | n/a | Prague |
| 91 | PreventaMed s.r.o. | Jiri Pumprla | Czech Republic | Olomouc | Olomouc |
| 92 | Regional Hospital Pardubice | Petr Vyhnalek | Czech Republic | Pardubice | Pardubice |
| 93 | Institute of Clinical and Experimental Medicine (IKEM) | Pavel Drastich | Czech Republic | Praha 4 | Prague |
| 94 | ISCARE a.s. | Milan Lukas | Czech Republic | Praha 9 | Prague |
| 95 | Creteil Intercommunal Hospital | Herve Hagege | France | Val-de-Marne | Creteil |
| 96 | Amiens Picardie Hospital | Mathurin Fumery | France | Somme | Amiens |
| 97 | North Hospital | Melanie Serrero | France | Provence-Alpes-C？te-d'Azur | Marseille |
| 98 | Hopital Claude Huriez | Pierre Desreumaux | France | Nord | Lille |
| 99 | South Lyon Hospital Center | Stephane Nancey | France | n/a | Pierre-Benite |
| 100 | Nantes University Hospital | Mathurin Flamant | France | n/a | Nantes |
| 101 | Blois Hospital | Dany Gargot | France | Loir-et-Cher | Blois |
| 102 | North Hospital | Xavier Roblin | France | Loire | Saint-Priest-en-Jarez |
| 103 | Hopital Albert Michallon | Nicolas Mathieu | France | Isère | Grenoble Cedex 9 |
| 104 | Hospital Pontchaillou | Guillaume Bouguen | France | Ille-et-Vilaine | Rennes |
| 105 | Beaujon Hospital | Xavier Treton | France | le-de-France | Clichy |
| 106 | Louis Mourier Hospital | Benoit Coffin | France | Hauts-de-Seine | Colombes |
| 107 | University Hospital of Rouen | Guillaume Savoye | France | Haute-Normandie | Rouen |
| 108 | Hospital de Rangueil | Cyrielle Gilletta De Saint Joseph | France | Haute-Garonne | Toulouse |
| 109 | Dijon University Hospital | Christophe Michiels | France | Cte-d'Or | Dijon |
| 110 | University Hosp. Center Caen | Marie-Astrid Piquet | France | Calvados | Caen |
| 111 | Medical Center | George Gvilia | Georgia | Tbilisi | Tbilisi |
| 112 | Israeli-Georgian MRC Helsicore | Nodar Emukhvari | Georgia | Tbilisi | Tbilisi |
| 113 | JSC Evex Medical Corporation | Marina Dadunashvili | Georgia | Tbilisi | Tbilisi |
| 114 | David Tatishvili Medical Cente | Irakli Khmaladze | Georgia | Tbilisi | Tbilisi |
| 115 | LLC 'Vivamedi' | Mimoza Kankia | Georgia | Tbilisi | Tbilisi |
| 116 | LTD Central University Clinic | Rusudan Shonia | Georgia | Tbilisi | Tbilisi |
| 117 | JSC Infectious Disease | Tamara Megrelishvili | Georgia | Tbilisi | Tbilisi |
| 118 | LTD Aversi Clinic | Tengiz Telia | Georgia | Tbilisi | Tbilisi |
| 119 | JSC Evex Medical Corporation | Nana Bolkvadze | Georgia | Batumi | Ajaria |
| 120 | Clinical Cardiology Institute | Manana Giorgadze | Georgia | Tbilisi | Tbilisi |
| 121 | Medius Clinic Nuertingen | Tanja Kuehbacher | Germany | Baden-Württemberg | Nuertingen |
| 122 | University Hospital Ulm | Jochen Klaus | Germany | Baden-Württemberg | Ulm |
| 123 | University Hospital Tuebingen | Stefano Fusco | Germany | Baden-Württemberg | Tuebingen |
| 124 | Medical Care Unit Dachau | Wilfred Landry | Germany | Bavaria | Dachau |
| 125 | Charite University Hospital | Christoph Jochum | Germany | Berlin | Berlin |
| 126 | Hospital Waldfriede e.V. | Carsten Buening | Germany | Berlin | Berlin |
| 127 | Charite University Hospital | Andreas Fischer | Germany | Berlin | Berlin |
| 128 | DRK Clinics Berlin | Andreas Sturm | Germany | Berlin | Berlin |
| 129 | Charite Hospital Berlin | Britta Siegmund | Germany | Berlin | Berlin |
| 130 | Ruppinen Hospital Ltd. | Karsten-Henrich Weylandt | Germany | Brandenburg | Neuruppin |
| 131 | Brandenburg City Hospital | Stefan Lueth | Germany | Brandenburg | Brandenburg an der Havel |
| 132 | Univ. Hosp. Hamburg-Eppendorf | Carolin Manthey | Germany | Hamburg | Hamburg |
| 133 | Crohn Colitis Cent. Rhein Main | Juergen Stein | Germany | Hessen | Frankfurt-am-Main |
| 134 | J W Goethe University Hospital | Irina Blumenstein | Germany | Hessen | Frankfurt-am-Main |
| 135 | Synexus Clinical Research GmbH | Christel Contzen | Germany | n/a | Frankfurt-am-Main |
| 136 | Synexus Leipzig Research Centr | Ekkehard Guertler | Germany | n/a | Leipzig |
| 137 | University Hospital Muenster | Phil Tepasse | Germany | Nordrhein-Westfalen | Muenster |
| 138 | Agaplesion Markus Hospital | Axel Dignass | Germany | Hessen | Frankfurt-am-Main |
| 139 | Practice for Gastroenterology | Peter Uebel | Germany | Rheinland-Pfalz | Ludwigshafen am Rhein |
| 140 | St.Marien-u. St.Annastifts-KH | Joerg Hoffmann | Germany | Rheinland-Pfalz | Ludwigshafen am Rhein |
| 141 | University Hospital Leipzig | Babett Holler | Germany | Sachsen | Leipzig |
| 142 | University Hospital Halle (Saale) | Jens Walldorf | Germany | Sachsen-Anhalt | Halle |
| 143 | Studiengesellschaft BSF | Lars Fechner | Germany | Sachsen-Anhalt | Halle |
| 144 | Univ. Hosp. Schleswig-Holstein | Stefan Schreiber | Germany | Schleswig-Holstein | Kiel |
| 145 | Alexandra General Hospital | Spyrido Michopoulos | Greece | Attiki | Athens |
| 146 | Metropolitan General | Theodoros Emmanouil | Greece | n/a | Athens |
| 147 | Thessaloniki General Hospital | Ioannis Goulis | Greece | Thessaloniki | Thessaloniki |
| 148 | Queen Mary Hospital | Wai Keung Leung | 中国香港 | n/a | Hong Kong |
| 149 | SYNEXUS Hungary | Janos Novak | Hungary | n/a | Gyula |
| 150 | Synexus Hungary Ltd. | Alajos Takats | Hungary | n/a | Budapest |
| 151 | Bekescsaba Rethy Pal Hospital | Marta Varga | Hungary | Békés | Bekescsaba |
| 152 | Fejer County St. Gyorgy Unive | Roland Fejes | Hungary | Fejér | Szekesfehervar |
| 153 | Kanizsai Dorottya Hospital | Laszlo Barany | Hungary | Zala | Nagykanizsa |
| 154 | Petz Aladar County Hospital | Istvan Racz | Hungary | Gyr-Moson-Sopron | Gyor |
| 155 | Medical Centre, Defence Forces | Laszlo Herszenyi | Hungary | Budapest | Budapest |
| 156 | Semmelweis University | Zsolt Tulassay | Hungary | Pest | Budapest |
| 157 | Csongrad County Hospital | Barnabas Bod | Hungary | Csongrád | Szentes |
| 158 | Clinfan Ltd | Agnes Salamon | Hungary | Szekszárd | Szekszárd |
| 159 | Beaumont Hospital | Stephen Patchett | Ireland | Dublin | Dublin |
| 160 | St Vincent's University Hospital | Juliette Sheridan | Ireland | Dublin | Dublin |
| 161 | Kaplan Medical Center, GI and Liver Disease Institute | Bruce Mosenkis | Israel | N/A | Rehovot |
| 162 | Shaare Zedek Medical Center | Eran Goldin | Israel | N/A | Jerusalem |
| 163 | Gastroenterology Division, Rabin Medical Center, Beilinson Campus | Irit Avni-Biron | Israel | N/A | Petah-Tikva |
| 164 | Gastroenterology Department, Outpatient Clinics, unit 9Sheba Medical Center | Adi Lahat-Zok | Israel | N/A | Ramat Gan (Tel Hashomer) |
| 165 | IBD unit, Institute of Gastroenterology and Liver Diseases, Emek Medical Center | Eran Zittan | Israel | N/A | Afula |
| 166 | Meir Medical Center, Gastroenerology &HepatologyStulberg Building | Yehuda Ringel | Israel | N/A | Kfar Saba |
| 167 | Rambam Health Care Campus | Mattitiahu Waterman | Israel | Bat Galim | Haifa |
| 168 | Hospital S. Camillo Forlanini | Rocco Cosintino | Italy | Roma | Roma |
| 169 | Humanitas Research Hospital | Laura Loy | Italy | Milano | Milan |
| 170 | Polyclinic San Matteo, IRCCS | Antonio Di Sabatino | Italy | Lombardia | Pavia |
| 171 | Mater Domini | Walter Fries | Italy | Sicillia | Messina |
| 172 | Agostino Gemelli | Antonio Gasbarrini | Italy | Roma | Roma |
| 173 | Sacred Heart Don Calabria | Andrea Geccherle | Italy | Verona | Negrar |
| 174 | Polyclinic S. Orsola-Malpighi | Paolo Gionchetti | Italy | Bologna | Bologna |
| 175 | ASST Monza | Pietro Invernizzi | Italy | Monza e Brianza | Monza |
| 176 | Mater Domini | Francesco Luzza | Italy | Calabria | Catanzaro |
| 177 | Integrated University Hospital | Marco Marino | Italy | Udine | Udine |
| 178 | Hospitals Villa Sofia Cervello | Ambrogio Orlando | Italy | Palermo | Palermo |
| 179 | Civil Hospital of Brescia | Chiara Ricci | Italy | Brescia | Brescia |
| 180 | Hospital of Padova | Edoardo Savarino | Italy | Padova | Padova |
| 181 | Ss. Annunziata | Matteo Neri | Italy | Abruzzo | Chieti |
| 182 | Poliambulanza Hospital | Cristiano Spada | Italy | Brescia | Brescia |
| 183 | IRCCS | Mauro Mastronardi | Italy | Bari | Bari |
| 184 | Kangbuk Samsung Hospital | Dong II Park | Korea | N/A | Seoul |
| 185 | The Catholic University of Korea St.Vincents Hospital | Kang-Moon Lee | Korea | Gyeonggi-do | Suwon |
| 186 | Severance Hospital, Yonsei University Health System | Jae Hee Cheon | Korea | N/A | Seoul |
| 187 | InJe University Haeundae Paik Hospital | TaeOh Kim | Korea | N/A | Busan |
| 188 | Yeungnam University Hospital | Byung Ik Jang | Korea | N/A | Daegu |
| 189 | Samsung Medical Center | Young Ho Kim | Korea | N/A | Seoul |
| 190 | Hanyang University Guri Hospital | Dong Soo Han | Korea | N/A | Gyeonggi-do |
| 191 | Seoul National University Bundang Hospital | Young Soo Park | Korea | Gyeonggi-do | Seongnam-si |
| 192 | Seoul National University Hospital | JongPil Im | Korea | N/A | Seoul |
| 193 | Clinical Trial Center | Seong-Eun Kim | Korea | South Korea | Seoul |
| 194 | Dong-A Medical Center | Jonghun Lee | Korea | n/a | Busan |
| 195 | LLC Digestive Diseases Centre | Marcis Leja | Latvia | Rīga | Rīga |
| 196 | P Stradins Clinical University | Aldis Pukitis | Latvia | Rīga | Rīga |
| 197 | Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V. | Roberto Ulises Cruz Neri | Mexico | Jalisco | Zapopan |
| 198 | Centro de Investigacion Clinica Acelerada (CICA) S.C. | Jose Gilberto Romero Lozano | Mexico | Mexico | Mexico |
| 199 | ICARO Investigaciones en Medicina S.A. de C.V. | Ramon Payan Olivas | Mexico | Chihuahua | Chihuahua |
| 200 | SMIQ | Claudio Marmolejo Garcia | Mexico | Queretaro | Queretaro |
| 201 | Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubiran ( INCMNSZ) | Jesus Katzuo Yamamoto-Furusho | Mexico | Ciudad de México | Tlalpan |
| 202 | Centro Regiomontano de Estudios Clinicos Roma | Azalia Ruiz | Mexico | Nuevo Leon | Monterrey |
| 203 | PMSI | Svetlana Turcan | Moldova | Chisinau | Chisinau |
| 204 | Sfanta Treime | Mihail Erlih | Moldova | Chisinau | Chisinau |
| 205 | Sf. Arhanghel Mihail Hospital | Valeriu Istrati | Moldova | Chisinau | Chisinau |
| 206 | PMSI | Tudor Timis | Moldova | Chisinau | Chisinau |
| 207 | Radboud Univ Medical Center | Willemijn van Dop | Netherlands | Gelderland | Nijmegen |
| 208 | Zuyderland Medical Center | Adriaan van Bodegraven | Netherlands | Limburg | Sittard |
| 209 | St. Elisabeth Hospital | Maurice Lutgens | Netherlands | Noord-Brabant | Tilburg |
| 210 | Academic Medical Center | Mark Lowenberg | Netherlands | n/a | Amsterdam |
| 211 | University Medical Center Groningen (UMCG) | Gerard Dijkstra | Netherlands | Groningen | Groningen |
| 212 | MDM Healthcare Centre | Marek Woynarowski | Poland | n/a | Warsaw |
| 213 | Synexus Polska Sp. z o.o. | Oleg Tyszkiwski | Poland | n/a | Poznan |
| 214 | Synexus Polska Sp. z o.o. | Michal Stepka | Poland | n/a | Warsaw |
| 215 | Synexus Polska Sp. z o.o. | Anna Orkwiszewska-Nalewajko | Poland | n/a | Gdynia |
| 216 | Synexus Polska Sp. z o.o. | Magdalena Olszanecka-Glinianowicz | Poland | n/a | Katowice |
| 217 | Synexus Polska Sp. z o.o. | Malgorzata Jagielska-Plata | Poland | n/a | Gdansk |
| 218 | Synexus Polska Sp. z o.o. | Zofia Jamrozik-Kruk | Poland | n/a | Czestochowa |
| 219 | Synexus Polska Sp. z o.o. | Mateusz Maciejewski | Poland | n/a | Lodz |
| 220 | Synexus Polska Sp. z o.o. | Agnieszka Ciesiolkiewicz-Wojcik | Poland | n/a | Wroclaw |
| 221 | WIP Warsaw IBD Point | Jaroslaw Kierkus | Poland | n/a | Warsaw |
| 222 | BioVirtus Medical Centre | Maria Orzeszko | Poland | Malopolska | Jozefow |
| 223 | SOLUMED Medical Center | Marek Karczewski | Poland | Wielkopolskie | Poznan |
| 224 | 1st Military Teaching Hospital | Przemyslaw Zajac | Poland | Maopolskie | Lublin |
| 225 | GLOBE Clinical Research | Rafal Dzygora | Poland | n/a | Klodzko |
| 226 | MaxMed Medical Services Centre | Bernadeta Gogola-Migdal | Poland | Maopolskie | Bochnia |
| 227 | Kornel Gibinski Hospital | Marek Hartleb | Poland | Slskie | Katowice |
| 228 | Jedrzej Sniadecki Hospitals | Agnieszka Janke | Poland | Podlaskie | Bialystok |
| 229 | Landa Specialist Doctor's Of | Katarzyna Landa | Poland | Maopolskie | Krakow |
| 230 | H-T Medical Center Endotherapy | Tomasz Romanczyk | Poland | Slskie | Tychy |
| 231 | Krakow Medical Center, LLC | Piotr Rozpondek | Poland | Maopolskie | Krakow |
| 232 | ETG Kielce Zagorska | Dariusz Solowiej | Poland | Swietokrzyskie | Kielce |
| 233 | SANTA FAMILIA Research | Maria Wisniewska-Jarosinska | Poland | Lodzkie | Lodz |
| 234 | Provincial Specialist Hospital | Tomasz Arlukowicz | Poland | Warminsko-mazurskie | Olsztyn |
| 235 | LEXMEDICA | Jerzy Rozciecha | Poland | Wroclaw | Wroclaw |
| 236 | EuroMediCare | Bernardeta Frysna | Poland | Wroclaw | Wroclaw |
| 237 | Orkan-Med Healthcare Centre | Krystyna Stec-Michalska | Poland | Lodzkie | Ksawerow |
| 238 | TWOJA PRZYCHODNIA Medical Centre of Szczecin | Beata Gawdis-Wojnarska | Poland | Pomorze Przednie | Szczecin |
| 239 | Salve Limited Company | Justyna Kotynia | Poland | Lodzkie | Lodz |
| 240 | Metabolic Diseases Clinic | Metabolic Diseases Clinic | Poland | n/a | Wierzchoslawice |
| 241 | Private Medical Practice M.Fic | Miroslaw Fic | Poland | Dolnoslaskie | Jelenia Gora |
| 242 | Office of Korczowski Bartosz | Bartosz Korczowski | Poland | Podkarpackie | Rzeszow |
| 243 | Allmedica Clinical Trials | Mikolaj Krzyzanowski | Poland | Maopolskie | Nowy Targ |
| 244 | D.Kleczkowski Medical Practice | Marek Horynski | Poland | Pomorskie | Sopot |
| 245 | Clinical Research Center | Piotr Napora | Poland | Wroclaw | Wroclaw |
| 246 | LUX MED Sp. z o.o. (LLC) | Pawel Petryszyn | Poland | Wroclaw | Wroclaw |
| 247 | Jan Mikulicz Radecki University Hospital in Wroclaw | Elzbieta Poniewierka | Poland | Dolnoslaskie | Wroclaw |
| 248 | PlanetMed Gastroenterology | Barbara Wozniak-Stolarska | Poland | Dolny Slask | Wroclaw |
| 249 | Barbara Wozniak-Stolarska | Krzysztof Niezgoda | Poland | Warminsko-mazurskie | Elblag |
| 250 | Local Unit of Health Alto Minh | Luis Miguel da Silva Araujo Lopes | Portugal | Viana do Castelo | Viana do Castelo |
| 251 | Targu Mures County Hospital | Maria Simona Bataga | Portugal | Mures | Targu Mures |
| 252 | Hospital Beatriz Angelo | Joana Torres | Portugal | Lisboa | Loures |
| 253 | Univ Hospital Center Coimbra | Francisco Portela | Romania | Coimbra | Coimbra |
| 254 | Provita Center of Diagnosis | Marieta Madalina Florescu | Romania | Bucuresti | Bucharest |
| 255 | Hyperclinic MedLife Grivita | Ion-Eugeniu Craciun | Romania | Bucuresti | Bucharest |
| 256 | Hyperclinic MedLife Grivita | Nicoleta Claudia Cimpoeru | Romania | Bucuresti | Bucharest |
| 257 | Fundeni Clinical Institute | Liliana Simona Gheorghe | Romania | Bucuresti | Bucharest |
| 258 | Colentina Clinical Hospital | Radu Bogdan Mateescu | Romania | Bucuresti | Bucharest |
| 259 | University Emergency Hospital | Lucian Negreanu | Romania | Bucuresti | Bucharest |
| 260 | Carol Davila Military Hospital | Mariana Jinga | Romania | Bucuresti | Bucharest |
| 261 | Territorial Clinical Hospital | Olga Ovchinnikova | Russia | Altayskiy kray | Barnaul |
| 262 | Diagnostic Center Bioterm Ltd. | Irina Belova | Russia | Altayskiy kray | Barnaul |
| 263 | Chelyabinsk Regional Hospital | Olga Nesmeyanova | Russia | Chelyabinskaya oblast | Chelyabinsk |
| 264 | Irkutsk State Medical Academy | Olga Fedorishina | Russia | Irkutskaya oblast | Irkutsk |
| 265 | Immanuel Kant Baltic Federal University | Vladimir Rafalskiy | Russia | Kaliningrad Oblast | Kaliningrad |
| 266 | S.V. Beliaev Regional Hospital | Evgenia Gerasimova | Russia | Kemerovskaya oblast | Kemerovo |
| 267 | Siberian Research Clin. Center | Viktoria Kashanskaya | Russia | Krasnoyarskiy kray | Krasnoyarsk |
| 268 | Clinical and Diagnostic Center | Elena Avalueva | Russia | Leningradskaya oblast | St. Petersburg |
| 269 | St. Elizabeth Hospital | Yulia Fominykh | Russia | Leningradskaya oblast | St. Petersburg |
| 270 | Kirov Military Medical Academy | Alexander Gordienko | Russia | Leningradskaya oblast | St. Petersburg |
| 271 | City Clinical Hospital #31 | Oksana Shchukina | Russia | Leningradskaya oblast | St. Petersburg |
| 272 | City Outpatient Care Unit #38 | Boris Starostin | Russia | Leningradskaya oblast | St. Petersburg |
| 273 | OLLA MED, LLC | Pavel Makarchuk | Russia | Moskva | Moscow |
| 274 | V.M. Buyanov City Hospital | Ilya Fedorov | Russia | Moskva | Moscow |
| 275 | Regional Clinical Hospital | Evgenia Sosnovskaya | Russia | n/a | Khanty-Mansiysk |
| 276 | Novgorod Regional Clinical Hos | Andrey Abdulin | Russia | Novgorodskaya oblast | Veliky Novgorod |
| 277 | Railway Station Hospital | Natalya Eremina | Russia | Novgorodskaya oblast | Nizhny Novgorod |
| 278 | Novosibirskiy Gastrocentr | Ekaterina Valuyskikh | Russia | Novgorodskaya oblast | Novosibirsk |
| 279 | Medical Center Sibnovomed, LLC | Marina Osipenko | Russia | Novgorodskaya oblast | Novosibirsk |
| 280 | Medical Diagnostic Center, LLC | Oleg Mironchev | Russia | Orenburgskaja oblast | Orenburg |
| 281 | N.N. Burdenko Penza Hospital | Natalia Galkina | Russia | Penzenskaja oblast | Penza |
| 282 | Primorsky Reg. Hospital No 1 | Olga Chesnokova | Russia | Primorskiy kray | Vladivostok |
| 283 | Myod Ltd. | Nadezhda Temnikova | Russia | Rostovskaya oblast | Bataisk |
| 284 | Rostov State Medical Univ. | Alexey Yakovlev | Russia | Rostovskaya oblast | Rostov-on-Don |
| 285 | Samara Station Railway Hospita | Pavel Andreev | Russia | Samarskaya oblast | Samara |
| 286 | Medical University | Elena Bunkova | Russia | Samarskaya oblast | Samara |
| 287 | EVROMEDSERVIS Private Medical | Irina Shumikhina | Russia | Sankt-Peterburg | St. Petersburg |
| 288 | I.I. Mechnikov State Univ. | Igor Bakulin | Russia | Sankt-Peterburg | St. Petersburg |
| 289 | S.M. Kirov Military Medical Ac | Vladimir Grinevich | Russia | Sankt-Peterburg | St. Petersburg |
| 290 | Regional Clinical Hospital | Olga Reshetko | Russia | Saratovskaja oblast | Saratov |
| 291 | Clinic UZI 4D, LLC | Daria Saenko | Russia | Stavropol'skij kraj | Pyatigorsk |
| 292 | Pyatigorsk City Clinical Hospi | Elena Bardina | Russia | Stavropol'skiy kray | Pyatigorsk |
| 293 | Medical Technologies | Marina Karakina | Russia | Sverdlovskaya oblast | Ekaterinburg |
| 294 | MA | Elina Petrova | Russia | Sverdlovskaya oblast | Ekaterinburg |
| 295 | Kazan City Clinical Hospital 7 | Dilyara Iskhakova | Russia | Tatarstan, Respublika | Kazan |
| 296 | Tomsk Regional Clinical Hospit | Evgenia Shepeleva | Russia | Tomskaya oblast | Tomsk |
| 297 | Tula Clinical Hospital | Julia Troshkina | Russia | Tul'skaya oblast | Tula |
| 298 | Regional Clinical Hospital | Olga Vasilyeva | Russia | Vladimirskaya oblast | Vladimir |
| 299 | Chita State Medical Academy | Albina Zhilina | Russia | Zabajkal'skij kraj | Chita |
| 300 | King Abdulaziz Medical city, National guard hospital, Riyadh | Abdullah Al Jahdali | Saudi Arabia | NA | Riyadh |
| 301 | King Khalid University Hospital | Othman Al Harbi | Saudi Arabia | NA | Riyadh |
| 302 | King AbdulAziz University Hospital Jeddah | Mahmoud Mosli | Saudi Arabia | NA | Riyadh |
| 303 | General Hospital Vrsac | Vladan Petrovic | Serbia | n/a | Vrsac |
| 304 | Dr. Dragisa Misovic-Dedinje | Branka Filipovic | Serbia | n/a | Belgrade |
| 305 | General Hospital Pancevo | Tatjana Djorovic | Serbia | Vojvodina | Pancevo |
| 306 | Military Medical Academy | Radoje Doder | Serbia | Beograd | Belgrade |
| 307 | Bezanijska Kosa Hospital Cente | Igor Jovanovic | Serbia | Beograd | Belgrade |
| 308 | General Hospital | Tatjana Radakovic | Serbia | Vojvodina | Zrenjanin |
| 309 | Zvezdara UMC | Petar Svorcan | Serbia | Beograd | Belgrade |
| 310 | Clinical Center Kragujevac | Natasa Zdravkovic Petrovic | Serbia | Sumadijski okrug | Kragujevac |
| 311 | World of the Health Inc. | Jan Zachar | Slovakia | Banskobystricky kraj | Rimavska Sobota |
| 312 | Gastromedic, s.r.o. | Iveta Kalisova | Slovakia | Nitriansky kraj | Nove Zamky |
| 313 | GASTRO I, s.r.o. | Ivan Bunganic | Slovakia | Presovsky kraj | Presov |
| 314 | Cliniq, s.r.o. | Tibor Hlavaty | Slovakia | Bratislavsky kraj | Bratislava |
| 315 | General Hospital Celje | Renata Sibli | Slovenia | Celje | Celje |
| 316 | Emmed Research | Johannes Breedt | South Africa | Gauteng | Muckleneuk |
| 317 | Lenasia Clinical Trial Centre | Naeem Moosa | South Africa | Gauteng | Johannesburg |
| 318 | Clinresco Centres | Jennifer Rosa | South Africa | Gauteng | Kempton Park |
| 319 | University Hospital Alicante | Rodrigo Jover Martinez | Spain | Valenciana, Comunidad | Alicante |
| 320 | Univ. Hospital de La Princesa | Francisco Javier Perez Gisbert | Spain | Madrid, Comunidad de | Madrid |
| 321 | Puerta de Hierro Majadajonda | Maria Isabel Vera Mendoza | Spain | Madrid, Comunidad de | Madrid |
| 322 | University Hospital La Paz | Maria Dolores Martin Arranz | Spain | Madrid | Madrid |
| 323 | Dr Negrin University Hospital | Daniel Ceballos Santos | Spain | Las Palmas | Las Palmas de Gran Canaria |
| 324 | Hospital of Girona Dr.J.Trueta | Xavier Aldeguer Mante | Spain | Catalunya | Girona |
| 325 | Teknon Medical Center | Miquel Dels Sant Sans Cuffi | Spain | Cataluna | Barcelona |
| 326 | University Hospital Marques de Valdecilla (HUMV), Department of Gastroenterology | Montserrat Rivero Tirado | Spain | Cantabria | Santander |
| 327 | HUC La Laguna | Laura Ramos | Spain | Canarias | Santa Cruz de Tenerife |
| 328 | Germans Trias i Pujol Hospital | Eugenio Domenech Morral | Spain | Barcelona | Badalona |
| 329 | Viladecans Hospital | Antonia Perello Juan | Spain | Barcelona | Barcelona |
| 330 | Hospital Reina Sofia | Jose Manuel Benitez Cantero | Spain | Andalucía | Cordoba |
| 331 | Lindenhofspital | Frank Seibold | Switzerland | Bern | Bern |
| 332 | Cantonal Hospital Saint Gallen | Stephan Brand | Switzerland | Sankt Gallen | St.Gallen |
| 333 | China Medical University Hospital | Jen-Wei Chou | 中国台湾 | N/A | Taichung City |
| 334 | National Cheng Kung University Hospital | Chiao-Hsiung Chuang | 中国台湾 | N/A | Tainan |
| 335 | Chang Gung Medical Hospital - LINKOU | Cheng-Tang Chiu | 中国台湾 | N/A | Taoyuan County |
| 336 | National Taiwan University Hospital | Chia-Hung Tu | 中国台湾 | N/A | Taipei |
| 337 | Goztepe Prof. Suleyman Yalcin | Celal Hak ULASOGLU | Turkey | Istanbul | Istanbul |
| 338 | Kocaeli University Medical Fac | Saadettin Hulagu | Turkey | Istanbul | Izmit/Kocaeli |
| 339 | Hacettepe Universitesi Hastanesi | Taylan Kav | Turkey | Ankara | Ankara |
| 340 | Karadeniz Teknik Universitesi Farabi Hastanesi | Murat Erkut | Turkey | Trabzon | Trabzon |
| 341 | Istanbul Sultanabdülhamit Han Egitim Arastirma Hastanesi | Yusuf Yazgan | Turkey | Istanbul | Istanbul |
| 342 | Bezmialem Vakif Universitesi Hastanesi | Hakan Senturk | Turkey | Istanbul | Istanbul |
| 343 | Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi | Selim Aydemir | Turkey | Zonguldak | Zonguldak |
| 344 | Synexus Midlands Clin Centre | Karen Faulkner | United Kingdom | Birmingham | Birmingham |
| 345 | Southampton General Hospital | James Rowland Fraser Cummings | United Kingdom | Hampshire | Southampton |
| 346 | Blackpool Victoria Hospital | Rhys Butcher | United Kingdom | Lancashire | Blackpool |
| 347 | Guy's Hospital | Mark Samaan | United Kingdom | London, City of | London |
| 348 | Royal London Hospital | Gareth Parkes | United Kingdom | London, City of | London |
| 349 | Synexus Hexham Research Centre | Shalini Iyengar | United Kingdom | n/a | Hexham |
| 350 | Synexus Wales CRC | Nimal Balaratnam | United Kingdom | n/a | Cardiff |
| 351 | Royal Shrewsbury Hospital | Jeff Butterworth | United Kingdom | n/a | Shrewsbury |
| 352 | University College Hospital | Ioanna Parisi | United Kingdom | n/a | London |
| 353 | Chernivtsi Regional Hospital | Oleksandr Fediv | Ukraine | Chernivets'ka Oblast' | Chernivtsi |
| 354 | Institute of Gastroenterology | Ihor Budzak | Ukraine | Dnipropetrovs'ka Oblast' | Dnipro |
| 355 | Ivano-Frankivsk Central Hospit | Vasyl Neiko | Ukraine | Ivano-Frankivs'ka Oblast' | Ivano-Frankivsk |
| 356 | Ivano-Frankivsk Reg. Hospital | Ihor Zbyrak | Ukraine | Ivano-Frankivs'ka Oblast | Ivano-Frankivsk |
| 357 | O.O. Shalimov City Hospital #2 | Oleksii Datsenko | Ukraine | Kharkivs'ka Oblast | Kharkiv |
| 358 | Khmelnytskyi Regional Hospital | Vitalii Balytskyi | Ukraine | Khmel'nyts'ka Oblast | Khmelnytskyi |
| 359 | Medical Center | Viktoriia Shevchuk | Ukraine | Kirovohrads'ka Oblast | Khmelnytskyi |
| 360 | Kyiv City Clinical Hospital 18 | Tetiana Kravchenko | Ukraine | Kyiv | Kyiv |
| 361 | Kyiv Regional Clinical Hospita | Tetiana Budko | Ukraine | Kyiv | Kyiv |
| 362 | Ok! Clinic | Svitlana Skybalo | Ukraine | Kyiv | Kyiv |
| 363 | Consylium Medical Center | Oksana Gerasymenko | Ukraine | Kyiv | Kyiv |
| 364 | Kyiv Regional Hospital #2 | Tetiana Lohdanidi | Ukraine | Kyiv | Kyiv |
| 365 | Kyiv Regional Clinical Hospita | Volodymyr Pirohovskyi | Ukraine | Kyiv | Kyiv |
| 366 | Lviv Regional Clinical Hospita | Yaroslav Zborivskyy | Ukraine | L'vivs'ka Oblast | Lviv |
| 367 | CENTER OF FAMILY MEDICINE PLUS | Liudmyla Chupryna | Ukraine | n/a | Kyiv |
| 368 | EDELWEISS MEDICS | Oleksandra Bilotkach | Ukraine | n/a | Kyiv |
| 369 | Medical Center within 'Medbud' | Dmytro Donets | Ukraine | n/a | Kyiv |
| 370 | Odesa Regional Clin. Hospital | Andriy Yurkiv | Ukraine | Odes'ka Oblast | Odesa |
| 371 | Poltava Sklifosovskyi Hospital | Igor Skrypnyk | Ukraine | Poltavs'ka Oblast | Poltava |
| 372 | Vinnytsia City Clinical Hosp 1 | Halyna Tomashkevych | Ukraine | Vinnyts'ka Oblast | Vinnytsia |
| 373 | Vinnytsia M.I.Pyrohov Hospital | Mykola Stanislavchuk | Ukraine | Vinnyts'ka Oblast | Vinnytsia |
| 374 | Health Clinic, LLC | Oleksandr Golovchenko | Ukraine | Vinnyts'ka Oblast | Vinnytsia |
| 375 | M.I. Pyrohov Regional Hospital | Natalia Kizlova | Ukraine | Vinnyts'ka Oblast | Vinnytsia |
| 376 | Clinic of the St. Nicholas | Kostyantyn Mylytsya | Ukraine | Zaporiz'ka Oblast' | Zaporizhia |
| 377 | Zaporizhia Regional Hospital | Serhii Svystun | Ukraine | Zaporiz'ka Oblast' | Zaporizhia |
| 378 | Volyn Regional Clin.Hospital | Oleh Tkachuk | Ukraine | Volyns'ka Oblast' | Lutsk |
| 379 | HonorHealth Research Institute | Akshay Shah | United States | Arizona | Scottsdale |
| 380 | Arkansas Gastroenterology, P.A. | Scott Wofford | United States | Arkansas | North Little Rock |
| 381 | Medical Associates Research Group | Hyun Kim | United States | California | San Diego |
| 382 | Inland Empire Liver Foundation | Zeid Kayali | United States | California | Rialto |
| 383 | OM Research LLC | Jatinder Pruthi | United States | California | Lancaster |
| 384 | VVCRD Clinical Research | Michael Kurtz | United States | California | Garden Grove |
| 385 | University of Southern California | Sarah Sheibani | United States | California | Los Angeles |
| 386 | Gastrointestinal Biosciences | Nicholas Karyotakis | United States | California | Los Angeles |
| 387 | Sharp Chula Vista Medical Center | Errol Korn | United States | California | Chula Vista |
| 388 | University of California, Davis | Eric Mao | United States | California | Sacramento |
| 389 | University of California San Francisco | Melvin Heyman | United States | California | San Francisco |
| 390 | Peak Gastroenterology Associates | Bhaktasharan Patel | United States | Colorado | Colorado Springs |
| 391 | Yale University - Digestive Disease | Deborah Proctor | United States | Connecticut | New Haven |
| 392 | Connecticut Clinical Research Institute | Salam Zakko | United States | Connecticut | Bristol |
| 393 | IMIC, Inc. | Miguel Rodriguez | United States | Florida | Palmetto Bay |
| 394 | Florida Center for Gastroenterology | Steven Beljic | United States | Florida | Largo |
| 395 | Galiz Research | Jose Gamez | United States | Florida | Hialeah |
| 396 | Gastroenterology Consultants of Clearwater | L. Michael Weiss | United States | Florida | Clearwater |
| 397 | Alliance Medical Research LLC | Vipin Gupta | United States | Florida | Lighthouse Point |
| 398 | HMD Research LLC | Marvin Heuer | United States | Florida | Orlando |
| 399 | Advanced Medical Research Center | Ammar Hemaidan | United States | Florida | Port Orange |
| 400 | Guardian Angel Research | Angel Rosario | United States | Florida | Tampa |
| 401 | Universal Axon Clinical Research | Luis Martinez | United States | Florida | Doral |
| 402 | Research Associates of South Florida | Javier Sobrado | United States | Florida | Miami |
| 403 | Life Medical Center & Research, Inc | Armando De Feria | United States | Florida | Miami |
| 404 | The Center for Gastrointestinal Disorders | Mark Lamet | United States | Florida | Hollywood |
| 405 | University of South Florida | Jorge Marcet | United States | Florida | Tampa |
| 406 | Bayside Clinical Research | Tatiana Hernandez | United States | Florida | New Port Richey |
| 407 | Nova Clinical Research Center Inc | Amado Viera | United States | Florida | Miami |
| 408 | Omega Research Maitland | Kwabena Ayesu | United States | Florida | Orlando |
| 409 | Qway Research LLC | Miguel Chamah | United States | Florida | Hialeah |
| 410 | NSB Research | Bryan Heath | United States | Florida | New Smyrna Beach |
| 411 | University of Florida Health (UF) | Angela Pham | United States | Florida | Gainesville |
| 412 | Atlanta Gastroenterology Associates | Douglas Wolf | United States | Georgia | Atlanta |
| 413 | Gastroenterology Associates of Central Georgia | Shahriar Sedghi | United States | Georgia | Macon |
| 414 | Emory University | Heba Iskandar | United States | Georgia | Atlanta |
| 415 | Children's Center for Digestive Health Care | Jeffery Lewis | United States | Georgia | Atlanta |
| 416 | Gastrointestinal Disease Research | Shankar Thiruppathi | United States | Georgia | Columbus |
| 417 | Atlanta Center for Gastroenterology, P.C. | David Rausher | United States | Georgia | Decatur |
| 418 | Consultative Gastroenterology | Gary Richter | United States | Georgia | Atlanta |
| 419 | Grand Teton Research Group, PLLC | Paul Hendrix | United States | Idaho | Idaho Falls |
| 420 | University of Chicago Medicine | Russell Cohen | United States | Illinois | Chicago |
| 421 | Northwestern Feinberg School of Medicine | Stephen Hanauer | United States | Illinois | Chicago |
| 422 | Rush University Medical Center - University Cardiovascular Surgeons | Ioannis Economou | United States | Illinois | Chicago |
| 423 | Southwest Gastroenterology | Kamran Ayub | United States | Illinois | Oak Lawn |
| 424 | Indiana University Hospital | Monika Fischer | United States | Indiana | Indianapolis |
| 425 | Medisphere Medical Research Center, LLC | Hubert Reyes | United States | Indiana | Evansville |
| 426 | Cotton-O'Neil Clinical Research Center, Digestive Health | Curtis Baum | United States | Kansas | Topeka |
| 427 | University of Kentucky Chandler Medical Center | Deborah Flomenhoft | United States | Kentucky | Lexington |
| 428 | Gastroenterology Associates, LLC | Jonathon Chapman | United States | Louisiana | Baton Rouge |
| 429 | Digestive Disease Associates, PA | Vijay Narayen | United States | Maryland | Catonsville |
| 430 | Woodholme Gastroenterology Associates | Kenolisa Onwueme | United States | Maryland | Glen Burnie |
| 431 | University of Massachusetts Memorial Medical Center | David Cave | United States | Massachusetts | Worcester |
| 432 | Brigham and Women's Hospital | Jessica Allegretti | United States | Massachusetts | Boston |
| 433 | Henry Ford Health System | Nirmal Kaur | United States | Michigan | Novi |
| 434 | Revival Research Institute LLC | Alan Cutler | United States | Michigan | Farmington Hills |
| 435 | Western Michigan University Homer Stryker M.D. School fo Medicine | Brij Dewan | United States | Michigan | Kalamazoo |
| 436 | Caro Health Plaza | Naveed Mahfooz | United States | Michigan | Saginaw |
| 437 | Mayo Clinic | Edward Loftus | United States | Minnesota | Rochester |
| 438 | University of Minnesota | Eugenia Shmidt | United States | Minnesota | Minneapolis |
| 439 | Southern Therapy and Advanced Research | Brian Borg | United States | Mississippi | Jackson |
| 440 | Washington University School of Medicine | Parakkal Deepak | United States | Missouri | St. Louis |
| 441 | Mid America Gastrointestinal Consultants | Hillary Bownik | United States | Missouri | Kansas City |
| 442 | Dartmouth-Hitchcock Medical Center | Corey Siegel | United States | New Hampshire | Lebanon |
| 443 | Northwell Health | Keith Sultan | United States | New York | Great Neck |
| 444 | Lenox Hill Hospital - Northwell Health | Arun Swaminath | United States | New York | New York |
| 445 | Drug Trials America | Michael Gerdis | United States | New York | Hartsdale |
| 446 | DiGiovanna Institute for Medical Education and Research | Michael DiGiovanna | United States | New York | North Massapequa |
| 447 | Weill Cornell Medicine | Randy Longman | United States | New York | New York |
| 448 | NY Scientific/Igor Grosman | Igor Grosman | United States | New York | Brooklyn |
| 449 | PMG Research of Winston-Salem, LLC | Robert Holmes | United States | North Carolina | Winston-Salem |
| 450 | Carolina Research/Carolina Digestive Diseases | Phillip Goldstein | United States | North Carolina | Greenville |
| 451 | CHS - Center for Digestive Health | John Hanson | United States | North Carolina | Charlotte |
| 452 | PMG Research of Charlotte, LLC | Fred Fowler | United States | North Carolina | Charlotte |
| 453 | Cleveland Clinic | Bret Lashner | United States | Ohio | Cleveland |
| 454 | The Ohio State University Wexner Medical Center | Anita Afzali | United States | Ohio | Columbus |
| 455 | Advance Clinical Research | Ugo Nwokoro | United States | Ohio | Dayton |
| 456 | Ohio GI and Liver Institute | Matthew Atkinson | United States | Ohio | Cincinnati |
| 457 | Central Sooner Research | Elise Wiesner | United States | Oklahoma | Norman |
| 458 | Digestive Disease Specialists Inc | David Stokesberry | United States | Oklahoma | Oklahoma City |
| 459 | Vital Prospects Clinical Research Institute, PC | Iftikhar Hussain | United States | Oklahoma | Tulsa |
| 460 | University of Oklahoma Health Sciences Center | Richard Harty | United States | Oklahoma | Oklahoma City |
| 461 | Essential Medical Research, LL | Aaron Fieker | United States | Oklahoma | Tulsa |
| 462 | Oregon Health and Science University | Nir Modiano | United States | Oregon | Portland |
| 463 | Penn State Milton S Hershey Medical Center | Kofi Clarke | United States | Pennsylvania | Hershey |
| 464 | Gastroenterology Associates of Orangeburg | Narayanachar Murali | United States | South Carolina | Orangeburg |
| 465 | Medical Univ of S Carolina | Erin Forster | United States | South Carolina | Charleston |
| 466 | Texas Digestive Disease Consultants | Timothy Ritter | United States | Texas | Southlake |
| 467 | Brooke Army Medical Center | John Gancayco | United States | Texas | Fort Sam Houston |
| 468 | Houston Methodist | Bincy Abraham | United States | Texas | Houston |
| 469 | DHAT Research Institute | Harry Sarles | United States | Texas | Garland |
| 470 | Tyler Research Institute | George Duvall | United States | Texas | Tyler |
| 471 | Sun Research Institute | Carl Dukes | United States | Texas | San Antonio |
| 472 | Baylor College of Medicine | Jason Hou | United States | Texas | Houston |
| 473 | Avant Research Associates, LLC | Rajesh Mehta | United States | Texas | Austin |
| 474 | San Antonio Gastroenterology Associates Clinical Trials (SAGACT) | Jeff Bullock | United States | Texas | San Antonio |
| 475 | Baylor Scott & White | Christopher Johnson | United States | Texas | Temple |
| 476 | The Coastal Medical Group | Rukan Daccak | United States | Texas | Houston |
| 477 | The University of Utah Health Sciences Center | Jessica Johnson | United States | Utah | Salt Lake City |
| 478 | Blue Ridge Medical Research | Larry Clark | United States | Virginia | Lynchburg |
| 479 | McGuire DVAMC | William Pandak | United States | Virginia | Richmond |
| 480 | Carilion Clinic | Maithili Chitnavis | United States | Virginia | Roanoke |
| 481 | Gleason Research, LLC | Gary Gleason | United States | Washington | Spokane |
| 482 | Mayo Clinic Health System - Franciscan Healthcare | Michael Van Norstrand | United States | Wisconsin | La Crosse |
| 483 | 常州市第二人民医院 | 刘文佳 | 中国 | 江苏省 | 常州市 |
| 484 | 苏州大学附属第二医院 | 唐文 | 中国 | 江苏省 | 苏州市 |
| 485 | 江苏大学附属医院 | 徐岷 | 中国 | 江苏省 | 镇江市 |
| 486 | 温州医科大学附属第二医院 | 蒋益 | 中国 | 浙江省 | 温州市 |
| 487 | 中国医科大学附属盛京医院 | 郑长青 | 中国 | 辽宁省 | 沈阳市 |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | 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 |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
六、试验状态信息
1、试验状态
进行中 （招募中）
2、试验人数
| 目标入组人数 | 国内: 90 ； 国际: 登记人暂未填写该信息； |
|---|---|
| 已入组人数 | 国内: 22 ； 国际: 登记人暂未填写该信息； |
| 实际入组总人数 | 国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息； |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 | 国内：2021-08-31； 国际：登记人暂未填写该信息； |
|---|---|
| 第一例受试者入组日期 | 国内：2021-12-27； 国际：登记人暂未填写该信息； |
| 试验完成日期 | 国内：登记人暂未填写该信息； 国际：登记人暂未填写该信息； |
七、临床试验结果摘要
| 序号 | 版本号 | 版本日期 |
|---|---|---|
| 暂未填写此信息 | ||
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