Ozanimod胶囊 |主动终止

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

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
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)
为受试者购买试验伤害保险

研究者信息

姓名 学位 职称 电话 Email 邮政地址 邮编 单位名称
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
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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

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问题