登记号
CTR20232876
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
非酒精性脂肪性肝炎（NASH）
试验通俗题目
评价 lanifibranor 治疗无肝硬化、伴 2 期（F2）/3 期（F3）肝纤维化的非酒精性脂肪性肝
炎（NASH）有效性和安全性
试验专业题目
一项评价 lanifibranor 在无肝硬化、伴 2 期（F2）/3 期（F3）肝纤维化的非酒精性脂肪性肝炎（NASH）成人受试者中有效性和安全性的多中心、随机、双盲、安慰剂对照加 lanifibranor扩展治疗的 III 期研究
试验方案编号
337HNAS20011（NATiV3）
方案最近版本号
4.0
版本日期
2023-01-11
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
戴峻
联系人座机
025-69927811
联系人手机号
13382796875
联系人Email
daijun@cttq.com
联系人邮政地址
江苏省-南京市-江宁区福英路1099号
联系人邮编
211100
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
本项 III 期研究旨在评价 lanifibranor 在 NASH 伴肝纤维化成人受试者中的作用.
主要队列两个周期的主要目的是：
双盲安慰剂对照（DBPC）期（A 部分）
评估与安慰剂相比，lanifibranor 在 NASH 缓解同时经肝组织学评估纤维化改善方面的效果。
双盲试验药扩展（ATE）治疗期（B 部分）
评估 DBPC 期后 lanifibranor 的安全性。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
无上限
(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 能够理解研究的性质，愿意并能够遵守研究程序和限制，并能够在开展任何研究相关活动、采样和分析之前，提供带有签名并注明日期的书面知情同意书。
- 如果在研究的前 72 周内搬家或搬迁，受试者愿意继续参加研究。
- 签署知情同意书时年龄≥18 岁的男性或女性。
- 如果在筛选前进行了活检，即有可用的既往活检记录，则 NASH 伴肝纤维化的组织学诊断 需在随机分组前 7 个月内进行。
- 主要队列：经中心活检阅片：根据脂肪变-活动性-纤维化（SAF）诊断 NASH： a) 脂肪变评分≥1 分 b) 活动性评分：A3 或 A4 c) 纤维化评分：F2 或 F3 该基于 SAF 的诊断转化为以下基于 CRN NAS 的诊断： CRN-脂肪变评分≥1 分、CRN-炎症（CRN-I）评分≥1 分和 CRN-气球样变（CRN-B） 评分≥1 分 NAS 评分≥5 分，或[NAS 评分≥4 分且 CRN-I≥2 分或 CRN-B≥2 分] CRN 纤维化评分：F2 或 F3 探索性队列：经中心活检阅片过程，不符合上述合格性标准但符合以下标准的受试者：根 据脂肪变-活动性-纤维化（SAF）确诊为 NASH： a) 脂肪变评分≥1 分 b) 活动性评分≥2 分，SAF-炎症评分≥1 分且 SAF-气球样变评分≥1 分 c) 纤维化评分：任何分期（F1 至 F4）。
- MELD 评分≤12 分（除非受试者正在使用抗凝剂）。
- 对于接受下列合并用药的受试者：不允许在既往肝活组织检查前或筛选访视前（以较长者为准）至基线访视（访视 0）的规定时间内定性改变剂量（允许暂时停药或改变药物类别等对临床影响最小的改变）： a) 胰高血糖素样肽-1 受体激动剂（GLP1 受体激动剂）或钠-葡萄糖协同转运蛋白-2 抑制剂（SGLT2 抑制剂）类降糖药物：至少 3 个月 b) 维生素 E（如果剂量≥400 IU/天）：至少 6 个月 c) 他汀类药物：至少 3 个月。
- 对于接受标准#7 未涵盖的合并用药的受试者（包括但不限于除 GLP1 受体激动剂和 SGLT2抑制剂以外的抗糖尿病治疗、抗高血压药、抗抑郁药、心血管药物、抗高脂血症药物等），在筛选访视前至少 3 个月至基线访视（访视 0）期间不允许对剂量进行定性变更。
- 对于超重/肥胖受试者，在过去 6 年内至少有 1 次尝试通过饮食和/或运动减轻体重失败史。
- 筛选前 6 个月内以及资格鉴定肝活检至基线之间体重稳定（两个阶段的变化均不超过 5%）。
- 从版本 3.0 起删除的标准。
- 受试者同意遵循生活方式调整的建议，将在整个研究期间进行监测。
- 有生育能力的女性在研究筛选时，经中心实验室确认血清妊娠试验结果为阴性。有生育能力的女性在整个研究期间和治疗中止后 1 个月内必须持续正确地使用高效避孕方法。高效避孕方法定义如下：与抑制排卵相关的联合激素（含雌激素和孕激素）避孕（口服、阴道内、经皮）、与抑制排卵相关的仅含孕激素的激素避孕（口服、注射、可植入）、宫内节育器（IUD）、宫内激素释放系统（IUS）、双侧输卵管阻塞、伴侣输精管切除（前提是该伴侣是女性受试者的唯一性伴侣，且输精管切除的伴侣已接受手术成功的医学评估）或禁欲（当该措施符合受试者的首选和常规生活方式时预期为真正禁欲；定期禁欲，如日历法、排卵法、症状体温法、排卵后方法和体外射精是不可接受的避孕方法）。只有同性关系的女性受试者不需要采取避孕措施。
排除标准
- 记录的除 NASH 以外的慢性肝病原因，包括但不限于： a) 记录为病毒性肝炎，伴 i. 乙肝表面抗原（HBsAg）阳性 ii. 丙型肝炎病毒核糖核酸（RNA）阳性（如果已知丙型肝炎病毒[HCV]感染已治愈 或筛选时 HCV 血清学阳性，则进行检测）如果有 HCV 感染史的受试者 HCV PCR 阴性超过 3 年，则可纳入可纳入。 b) 药物性肝损害 c) 酒精性肝病：有饮酒史的受试者，AST:ALT 比值≥2，γ-谷氨酰转移酶（GGT）> 2×正常值上限（ULN），大红细胞症伴平均红细胞容积（MCV）> 95 fL，无已知病因的维生素 B12 不足 d) 自身免疫性肝炎 e) 威尔森病 f) 血色素沉着症 g) 原发性胆汁性胆管炎 h) 原发性硬化性胆管炎 i) α-1 抗胰蛋白酶缺乏症 j) 慢性门静脉血栓形成或脾静脉血栓。
- 既往活检中经组织学证实的肝硬化（纤维化 F4 期）或根据研究者评估的临床生化和影像学标准在筛选时怀疑肝硬化（请见第 9.1.1 节）。
- 既往或当前诊断为肝细胞癌（HCC）。
- 肝移植史或计划进行肝移植。
- 筛选时（如果没有适合的既往活检记录供中心审查）和第 72 周时，无法或不愿意接受肝活组织检查。
- 人类免疫缺陷病毒（HIV）血清学阳性。
- ALT 或 AST > 5×ULN 7.1 如果必须在研究范围内进行筛选肝活组织检查，则 AST<0.60×ULN 7.2 如果必须在研究范围内进行筛选肝脏活检，则在筛选期间经瞬时弹性成像（或等同方法）测定的肝脏硬度值（LSM）<6 kPa。
- 根据筛选时中心实验室评价具有以下任何一项确定的合成肝功能异常： a) 白蛋白低于正常范围下限 b) 国际标准化比率（INR）≥1.3（除非受试者正在使用抗凝剂） c) 总胆红素水平≥1.5 mg/dL（25.6 μmol/L）。如果直接胆红素≤0.45 mg/dL（7.7 μmol/L），则可入组有 Gilbert 综合征病史的受试者。
- 女性血红蛋白 < 110 g/L（11 g/dL），男性 < 120 g/L（12 g/dL）
- 白细胞计数 < LLN。如果研究者认为无临床意义，则良性种族中性粒细胞减少症受试者的计数降低是可以接受的。
- 血小板计数 < 140,000/μL。
- 碱性磷酸酶（ALP）> 2×ULN。
- 受试者目前正在接受任何获批的 NASH 或肥胖治疗。
- 当前或近期显著饮酒史（< 5 年），通常定义为男性每天超过 30 g 纯酒精，女性每天超过 20g 纯酒精（也请参见第 13.1 节）。去年没有酗酒。在约 2 小时内摄入 75 g 纯酒精（男性）或60 g 纯酒精（女性）或更多。
- 在资格鉴定肝活检前 12 个月内接受可能引起非酒精性脂肪性肝病（NAFLD）的药物治疗至少 2 周（例如丙戊酸、他莫昔芬、甲氨蝶呤、胺碘酮、口服糖皮质激素 > 5 mg/天泼尼松当量[允许在肝活组织检查前 3 个月及以上时间，接受短疗程（< 2 周）口服糖皮质激素治疗]或雌激素[剂量大于用于避孕或激素替代的剂量]）。
- 筛选时 HbA1c > 9%。
- 2 型糖尿病以外的糖尿病（例如，1 型、内分泌病和遗传综合征）。
- 当前接受胰岛素治疗。
- 在筛选或既往活检前 12 个月接受 PPAR-γ激动剂（如噻唑烷二酮类[TZD]）治疗，或因安全性原因而停用 TZD 的任何病史，如体重增加或贫血。
- 减肥手术：允许纳入资格鉴定肝活检前>6 个月行限制性手术者（例如，胃束带术、胃内气囊、袖状胃切除术）；不允许纳入资格鉴定肝活检前 5 年内行吸收不良手术（例如，胆胰分流术）以及限制性和吸收不良联合手术者（例如，Roux-en-Y 胃旁路术、十二指肠转位术）。允许纳入在资格鉴定肝活检前 > 6 个月行抽脂术和/或腹壁整形术者。不允许纳入行计划减肥手术者。
- 在研究前 3 个月内参加过有组织的体重下降计划（例如 weight Watchers®,Jenny Craig®），或计划参加该计划直至第 72 周。
- 心力衰竭病史伴左心室射血分数（LVEF）降低，定义为既往 LVEF 测量值≤40%。
- N-末端-激素原 B 型利尿钠肽（Nt-proBNP）> 900 pg/mL。
- 需要抗凝治疗的房颤。
- 不稳定的射血分数保留性心力衰竭，定义为： a) 纽约心脏病协会（NYHA）III-IV 级或， b) 过去 1 年内因心力衰竭住院或急诊就诊，或 c) 在筛选前 6 个月内需要在门诊静脉注射利尿剂，或， d) 合并使用高剂量利尿剂治疗（即呋塞米 80 mg/天或等效药物）。
- 筛选前 6 个月内发生任何其他需要住院的具有临床意义的心血管事件。
- 筛选时不受控制的高血压：收缩压 > 160 mmHg 或舒张压 > 100 mmHg（在第 9.2.3 节所述的条件下）。
- 采用 Fridericia 公式校正的 QT 间期（QTcF）> 480 ms。
- 根据研究者的评价，任何其他不稳定或未经治疗的具有临床意义的肝脏、肺、免疫学、内分泌、血液学、胃肠道、神经系统、肿瘤（也见排除标准#30）、精神疾病或可能使预期寿命缩短至 2 年以下的任何医学疾病的证据。
- 癌症：筛选前 5 年内有恶性肿瘤现病史或恶性肿瘤史。有书面记录表明缓解已有 5 年的癌症史是允许的。排除 HCC 病史（见排除标准#3）。在切除病灶的情况下，允许存在基底和鳞状细胞皮肤癌和任何原位癌。
- 计划在研究的前 72 周进行大手术，例如，妨碍受试者接受研究治疗超过 2 周。
- 研究者认为可能危及受试者安全或方案依从性，或需要从研究中排除的任何情况。
- 目前正在哺乳的女性。
- 已知或疑似对 lanifibranor/安慰剂或 PPAR 激动剂的任何辅料（包括苯甲酸钠，E211）过敏。
- 伴有罕见的半乳糖不耐受遗传性问题、总乳糖酶缺乏症或葡萄糖-半乳糖吸收不良的受试者。
- 既往暴露于 lanifibranor。
- 在筛选前 3 个月内或筛选后 5 个半衰期内（以较长者为准）参加任何已批准或未批准的试验用药品/器械的临床试验。
- 估计肾小球滤过率（eGFR）< 60 mL/min 的肾功能损害。
- 筛选时甘油三酯 > 500 mg/dL（5.65 mmol/L）。
- PPAR-α激动剂（贝特类药物）合并治疗；适当时，如果预计研究期间甘油三酯将保持 < 500 mg/dL，则最迟在基线访视前可中止 PPAR-α激动剂治疗。
- CYP2C8 强效诱导剂或抑制剂治疗。长期给药时，应在筛选访视前 3 个月替换（见入选标准#8）。如果未长期给药，应在随机分组前至少 7 天停止给药。（见第 7.7 节和第 13.2 节）。
- 过去 3 个月内感染 SARS-CoV-2，需要住院治疗，或经验证试验证实，当前感染 SARS-CoV-2。（在筛选访视时，不需要对所有受试者进行 SARS-CoV-2 检测，但将根据当地标准惯例进行检测）。如果受试者近期有既往 SARS-CoV-2 感染，则应在随机分组前进行异常实验室检测检查，证实恢复到新冠肺炎之前的状态。
- 已知与 QTcF 延长 > 480 ms 相关的合并治疗（见第 13.4 节）。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:NA
|
剂型:片剂
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:NA
|
剂型:片剂
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 与安慰剂相关，用组织学方法评价lanifibranor 治疗对NASH 的安全性与有效性 | 接受研究药物治疗第 72 周 | 有效性指标+安全性指标 |
| 评估lanifibranor 在DBPC期后的安全性 | 末次访视 | 安全性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 与安慰剂比较，评价对NASH 缓解且纤维化无恶化 | 接受研究药物治疗第 72 周 | 有效性指标 |
| 与安慰剂比较，评价对纤维化改善且 NASH 无恶化 | 接受研究药物治疗第 72 周 | 有效性指标 |
| 评价lanifibranor 对NASH的其他 组织学特征的影响 | DBPC 期间 | 有效性指标 |
| 评价lanifibranor 对伴糖尿病患者的NASH的缓解与改善的影响 | DBPC 期间 | 有效性指标 |
| 评价lanifibranor 对肝脏检查的影响 | 在 DBPC 和 ATE 期的所有适用访视时 | 安全性指标 |
| 评价lanifibranor 对血糖指标的影响 | 在 DBPC 和 ATE 期的所有适用访视时 | 安全性指标 |
| 评价lanifibranor 对血脂参数的影响 | 在 DBPC 和 ATE 期的所有适用访视时 | 安全性指标 |
| 通过fibroscan技术评估对肝硬化和脂肪变性的影响 | 在 DBPC 和 ATE 期的所有适用访视时 | 有效性指标+安全性指标 |
| 评估lanifibranor 对健康相关生活质量的影响 | 在 DBPC 和 ATE 期间的所有适用访视 | 安全性指标 |
| 评估lanifibranor 的安全性 | 在 DBPC 和 ATE 期间的所有适用访视 | 安全性指标 |
| 采用稀疏采样方案通过 lanifibranor 的血浆浓 度进行的群体 PK 模型 | DBPC 期间 | 有效性指标+安全性指标 |
数据安全监察委员会（DMC）
无
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 牛俊奇 | 医学博士 | 主任医师 | 13756661205 | junqiniu@aliyun.com | 吉林省-长春市-新民大街 1 号 | 130031 | 吉林大学第一医院 |
| 任红 | 医学硕士 | 主任医师 | 13983888786 | renhong0531@vip.sina.com | 重庆市-重庆市-渝中区临江路76号 | 400010 | 重庆医科大学附属第二医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 吉林大学第一医院 | 牛俊奇 | 中国 | 吉林省 | 长春市 |
| 重庆医科大学附属第二医院 | 任红 | 中国 | 重庆市 | 重庆市 |
| 中南大学湘雅医院 | 刘菲 | 中国 | 湖南省 | 长沙市 |
| 北京大学人民医院 | 封波 | 中国 | 北京市 | 北京市 |
| 首都医科大学附属北京佑安医院 | 徐斌 | 中国 | 北京市 | 北京市 |
| 首都医科大学附属北京地坛医院 | 谢雯 | 中国 | 北京市 | 北京市 |
| 北京大学第一医院 | 于岩岩 | 中国 | 北京市 | 北京市 |
| 天津市第二人民医院 | 李嘉 | 中国 | 天津市 | 天津市 |
| 天津市第三中心医院 | 王凤梅 | 中国 | 天津市 | 天津市 |
| 天津医科大学总医院 | 王邦茂 | 中国 | 天津市 | 天津市 |
| 华中科技大学同济医学院附属协和医院 | 杨玲/蔺蓉 | 中国 | 湖北省 | 武汉市 |
| 兰州大学第一医院 | 毛小荣 | 中国 | 甘肃省 | 兰州市 |
| 西安国际医学中心有限公司 | 韩国宏 | 中国 | 陕西省 | 西安市 |
| 西安交通大学第一附属医院 | 叶峰 | 中国 | 陕西省 | 西安市 |
| 南方医科大学南方医院 | 侯金林 | 中国 | 广东省 | 广州市 |
| 中山大学附属第一医院 | 钟碧慧 | 中国 | 广东省 | 广州市 |
| 广州市第一人民医院 | 陈慧婷 | 中国 | 广东省 | 广州市 |
| 广州医科大学附属市八医院 | 关玉娟 | 中国 | 广东省 | 广州市 |
| 广西医科大学第一附属医院 | 刘志红 | 中国 | 广西壮族自治区 | 南宁市 |
| 重庆医科大学附属第一医院 | 李用国 | 中国 | 重庆市 | 重庆市 |
| 四川大学华西医院 | 李红 | 中国 | 四川省 | 成都市 |
| 四川省人民医院 | 杨兴祥 | 中国 | 四川省 | 成都市 |
| 贵州省人民医院 | 罗新华 | 中国 | 贵州省 | 贵阳市 |
| 贵州医科大学附属医院 | 张权 | 中国 | 贵州省 | 贵阳市 |
| 云南省第一人民医院 | 宋正己 | 中国 | 云南省 | 昆明市 |
| 中国人民解放军陆军军医大学第一附属医院 | 毛青 | 中国 | 重庆市 | 重庆市 |
| 重庆大学附属三峡医院（重庆三峡中心医院、重庆市三峡肿瘤防治研究所、重庆万州精神卫生中心） | 安选 | 中国 | 重庆市 | 重庆市 |
| 南昌大学第二附属医院 | 孙水林 | 中国 | 江西省 | 南昌市 |
| 宁波市第二医院 | 李红山 | 中国 | 浙江省 | 宁波市 |
| 瑞安市人民医院（瑞安市人民医院医疗服务集团瑞安市妇幼保健院瑞安市红十字医院） | 洪亮 | 中国 | 浙江省 | 温州市 |
| 温州医科大学附属第一医院 | 郑明华 | 中国 | 浙江省 | 温州市 |
| 浙江大学医学院附属第一医院 | 盛吉芳 | 中国 | 浙江省 | 杭州市 |
| 镇江市第三人民医院 | 葛国洪 | 中国 | 江苏省 | 镇江市 |
| 浙江大学医学院附属邵逸夫医院 | 吕芳芳 | 中国 | 浙江省 | 杭州市 |
| 南通大学附属医院 | 陆翠华 | 中国 | 江苏省 | 南通市 |
| 苏州市第五人民医院 | 朱传武 | 中国 | 江苏省 | 苏州市 |
| 福建医科大学附属第一医院 | 朱月永 | 中国 | 福建省 | 福州市 |
| 福建医科大学孟超肝胆医院 | 郑丽青 | 中国 | 福建省 | 福州市 |
| 江苏省人民医院 | 李军 | 中国 | 江苏省 | 南京市 |
| 南京市第二医院 | 杨永峰 | 中国 | 江苏省 | 南京市 |
| 大连医科大学附属第二医院 | 李荣宽 | 中国 | 辽宁省 | 大连市 |
| 哈尔滨医科大学附属第四医院 | 于雷 | 中国 | 黑龙江省 | 哈尔滨市 |
| 沈阳市第六人民医院 | 赵蕊 | 中国 | 辽宁省 | 沈阳市 |
| 中国医科大学附属第一医院 | 李异玲 | 中国 | 辽宁省 | 沈阳市 |
| 中国医科大学附属盛京医院 | 丁洋 | 中国 | 辽宁省 | 沈阳市 |
| 河南科技大学第一附属医院 | 张英剑 | 中国 | 河南省 | 洛阳市 |
| 河南省人民医院 | 尚佳 | 中国 | 河南省 | 郑州市 |
| 三门峡市中心医院 | 董小平 | 中国 | 河南省 | 三门峡市 |
| 郑州大学第一附属医院 | 余祖江 | 中国 | 河南省 | 郑州市 |
| 郑州市第六人民医院 | 李广明 | 中国 | 河南省 | 郑州市 |
| 郑州市第一人民医院 | 陈佩 | 中国 | 河南省 | 郑州市 |
| 青岛市市立医院（青岛市医学影像学中心、青岛市临床医学研究所、青岛市北九水疗养院） | 辛永宁 | 中国 | 山东省 | 青岛市 |
| 青岛市中心医院 | 赵红 | 中国 | 山东省 | 青岛市 |
| 山西医科大学第二医院 | 武希润 | 中国 | 山西省 | 太原市 |
| 山西医科大学第一医院 | 徐钧 | 中国 | 山西省 | 太原市 |
| 中山大学附属第三医院 | 邓洪 | 中国 | 广东省 | 广州市 |
| 上海交通大学医学院附属瑞金医院 | 谢青 | 中国 | 上海市 | 上海市 |
| 南阳医学高等专科学校第一附属医院 | 朱海超 | 中国 | 河南省 | 南阳市 |
| 广东省人民医院 | 沙卫红 | 中国 | 广东省 | 广州市 |
| 香港大学深圳医院 | 吕涛 | 中国 | 广东省 | 深圳市 |
| 无锡市第五人民医院 | 汪铮 | 中国 | 江苏省 | 无锡市 |
| Hospital Italiano La Plata | Adrover, Raúl Eduardo | Argentina | Buenos Aires | La Plata |
| Hospital Universitario Austral | Silva, Marcelo | Argentina | Buenos Aires | Pilar |
| Hospital El Cruce - Dr. Nestor Kirchner | Villamil, Federico | Argentina | Buenos Aires | Florencio Varela |
| Hospital Provincial del Centenario | Bessone, Fernando | Argentina | Santa Fe | Rosario |
| Hospital Italiano de Buenos Aires | Casciato, Paola | Argentina | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Buenos Aires British Hospital | Colombato, Luis | Argentina | / | Buenos Aires |
| Concord Repatriation General Hospital | Lee, Alice | Australia | Brussels | Concord |
| Austin Health | Sinclair, Marie | Australia | Victoria | Heidelberg |
| Gallipoli Medical Research Foundation | Crawford, Darrell | Australia | Queensland | Greenslopes |
| Nepean Hospital | Weltman, Martin | Australia | New South Wales | Penrith |
| Liverpool Hospital | Davison, Scott | Australia | New South Wales | Liverpool |
| Royal Perth Hospital | Kontorinis, Nicholas | Australia | Western Australia | Perth |
| Campbelltown Hospital | Ho, Vincent | Australia | New South Wales | Liverpool |
| Royal Brisbane and Women's Hospital | Skoien, Richard | Australia | Queensland | Herston |
| John Hunter Hospital | Gan, Lay Theng | Australia | New South Wales | New Lambton |
| Fiona Stanley Hospital | Ayonrinde, Oyekoya | Australia | Western Australia | Murdoch |
| Monash Medical Centre | Pianko, Stephen | Australia | Victoria | Clayton |
| Eastern Health - Australia | Hodge, Alexander | Australia | Victoria | Box Hill |
| Medical University of Innsbruck | Zoller, Heinz | Austria | Tyrol | Innsbruck |
| Algemeen Ziekenhuis Maria Middelares | Van Steenkiste, Christophe | Belgium | Oost-Vlaaderen | Gent |
| Cliniques Universitaires Saint-Luc | Lanthier, Nicolas | Belgium | / | Brussels |
| Erasmus Hospital | Moreno, Christophe | Belgium | Brussels | Bruxelles |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan | Schoonjans, Christophe | Belgium | West-Vlaanderen | Brugge |
| Universitair Ziekenhuis Antwerpen | Francque, Sven | Belgium | Antwerpen | Edegem |
| Universitair Ziekenhuis Gent | Geerts, Anja | Belgium | Oost-Vlaanderen | Gent |
| Liege University Hospital, Sart Tilman | Delwaide, Jean | Belgium | Liege | Liege |
| Ziekenhuis Oost-Limburg - Campus Sint-Jan | Struyve, Mathieu | Belgium | Limburg | Genk |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Verbeek, Jef | Belgium | Flemish Brabant | Leuven |
| Algemeen Ziekenhuis Delta - Campus Rumbeke | De Vloo, Charlotte | Belgium | West-Vlaanderen | Roeselare |
| Vitaz | Schouten, Jeoffrey | Belgium | Oost-Vlaanderen | Sint-Niklaas |
| Clinical Hospital of Ribeirao Preto Medical School | Araujo, Roberta | Brazil | Sao Paulo | Ribeirao Preto |
| Clinical Hospital of Porto Alegre | Da Silva, Mario | Brazil | Rio Grande do Sul | Porto Alegre |
| Regional Faculty of Medicine, Sao Jose do Rio Preto Foundation | Da Silva, Rita De Cassia Martins Alves | Brazil | Sao Paulo | Sao Jose do Rio Preto |
| Hospital Ernesto Dornelles | Sander, Guilherme | Brazil | Rio Grande do Sul | Porto Alegre |
| Clinical Hospital of the Faculty of Medicine of the University | de Oliveira, Claudia | Brazil | Sao Paulo | Sao Paulo |
| Hospital das Clinicas da Universidade Federal de Minas Gerais | Couto, Claudia | Brazil | Minas Gerais | Belo Horizonte |
| Acibadem City Clinic Tokuda Hospital | Balabanska, Rozalina | Bulgaria | / | Sofia |
| Diagnostic Consultative Center Aleksandrovska | Stefanova-Petrova, Diana | Bulgaria | Sofia City | Sofia |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov | Danov, Kamen | Bulgaria | Sofia City | Sofia |
| Diagnostic Consulting Center 20 - Sofia Еооd | Dimitrov, Dimitar | Bulgaria | Sofia City | Sofia |
| Medical Center Medica Plus | Kosturkov, Ilko | Bulgaria | / | Veliko Tarnovo |
| University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Jelev, Deian | Bulgaria | Sofia City | Sofia |
| Nov Rehabilitatsionen Tsentar EOOD | Radicheva, Mariana | Bulgaria | Stara Zagora | Stara Zagora |
| Toronto Digestive Disease Associates | Greenbloom, Susan | Canada | Ontario | Vaughan |
| William Osler Health System - Brampton Civic Hospital | Chandok, Natasha | Canada | Ontario | Brampton |
| Heritage Medical Research Centre | Stinton, Laura | Canada | Alberta | Calgary |
| McGill University Health Centre | Sebastiani, Giada | Canada | Quebec | Montreal |
| St. Joseph's Healthcare Hamilton - Charlton Campus | Tsoi, Keith | Canada | Ontario | Hamilton |
| University Health Network | Wong, Florence | Canada | Ontario | Toronto |
| Lanaudiere Metabolic Medicine Center | Robitaille, Yves | Canada | Quebec | Terrebonne |
| Clinical Research Center of Vina del mar | Fuster Saldias, Francisco | Chile | Valparaiso | Vina del Mar |
| Pontifical Catholic University of Chile - School of Medicine | Arrese Jimenez, Marco | Chile | Region Metropolitana de Santiago | Region Metropolitana |
| Hospital San Juan de Dios de La Serena | Valera Millas, Jose Miguel | Chile | Coquimbo | La Serena |
| Research Site s.r.o. | Hejda, Vaclav | Czech Republic | Plzen | Plzen |
| Synexus - Prague | Smid, Vaclav | Czech Republic | Prague | Prague 2 |
| Saint-Antoine Hospital | Poujol-Robert, Armelle | France | Paris | Paris Cedex 12 |
| Archet Hospital | Tran, Albert | France | Provence-Alpes-Cote d'Azur | Nice Cedex 3 |
| Brabois Hospitals | Bronowicki, Jean-Pierre | France | Lorraine | Vandoeuvre-les-Nancy |
| Clinique Pasteur - Toulouse | Guillaume, Maeva | France | Occitanie | Toulouse |
| Rangueil Hospital | Bureau, Christophe | France | Occitanie | Toulouse |
| Centre Hosptitalier Universitaire d'Angers | Boursier, Jerome | France | Pays de la Loire | Angers |
| Paris-Sud University Hospitals - Paul Brousse Hospital | Coilly, Audrey | France | Ile-de-france | Villejuif Cedex |
| New Civil Hospital | Serfaty, Lawrence | France | Bas-Rhin | Strasbourg |
| Hospital Haut-Leveque | De Ledinghen, Victor | France | Nouvelle-Aquitaine | Pessac |
| University Hospitals Paris Nord Val de Seine - Beaujon Hospital | Castera, Laurent | France | Ile-de-France | Clichy Cedex |
| Claude Huriez Hospital | Mathurin, Philippe | France | Nord | Lille |
| Centre Hospitalier Universitaire Estaing | Abergel, Armando | France | Puy-de-Dome | Clermont-Ferrand |
| Centre Hospitalier Universitaire Grenoble Alpes | Costentin, Charlotte | France | Isere | Grenoble |
| Saint-Eloi Hospital | Faure, Stephanie | France | Provence Alpes Cote d'Azur | Montpellier Cedex 5 |
| Saint Joseph Hospital, Marseille | Bourlière, Marc | France | / | Marseille |
| Centre Hospitalier Universitaire Limoges | Loustaud Ratti, Veronique | France | Limousin | Limoges cedex |
| Croix-Rousse Hospital | Levrero, Massimo | France | Rhone-alpes | Lyon |
| Pitie-Salpetriere University Hospital | Ratziu, Vlad | France | Ile-de-France | Paris |
| Henri Mondor University Hospitals | Leroy, Vincent | France | Ile-de-France | Creteil |
| Cochin Hospital | Pol, Stanislas | France | Ile-de-France | Paris |
| Regional University Hospital of Besancon - Jean-Minjoz Hospital | Di Martino, Vincent | France | Franche-Comte | Besancon Cedex |
| Centre Hospitalier Universitaire de Rennes | Bardou-Jacquet, Edouard | France | Ille-et-Vilaine | Rennes |
| Nantes University Hospital - North Laennec Hospital | Cariou, Bertrand | France | Nantes Cedex 1 | Nantes |
| Dijon Bourgogne University Hospital - Francois Mitterrand Hospital | Petit, Jean-Michel | France | Cantal | Dijon |
| Universitatsklinikum Carl Gustav Carus Dresden | Berning, Marco | Germany | Sachsen | Dresden |
| Klinikum Chemnitz | Wissniowski, Th. Till | Germany | Sachsen | Chemnitz |
| EPIMED | Arasteh, Keikawus | Germany | Berlin | Berlin |
| Saarland University Hospital | Krawczyk, Marcin | Germany | Saarland | Homburg |
| Klinische Forschung Karlsruhe GmbH | Chevts, Julia | Germany | Baden-Wurttemberg | Karlsruhe |
| Gastroenterologische Gemeinschaftspraxis Herne | Von Der Ohe, Manfred | Germany | NORDRHEIN-WESTFALEN | Herne |
| Charite – Berlin University Medicine | Demir, Münevver | Germany | Berlin | Berlin |
| University Medical Center of Johannes Gutenberg University Mainz | Schattenberg, Jorn | Germany | Rheinland-Pfalz | Mainz |
| St. Josefs-Hospital Wiesbaden | Sarrazin, Christoph | Germany | Hessen | Wiesbaden |
| Eugastro | Schiefke, Ingolf | Germany | Sachsen | Leipzig |
| University Hospital Cologne | Schulte, Sigrid | Germany | Nordrhein-Westfalen | Koln |
| Gastroenterologie am Bayerischen Platz | Hofmann, Wolf Peter | Germany | Berlin | Berlin |
| University Medical Center Schleswig-Holstein - Lubeck Campus | Marquardt, Jens | Germany | Schleswig-Holstein | Lubeck |
| MIND Klinika | Gyokeres, Tibor | Hungary | Budapest | Budapest |
| University of Debrecen Clinical Center - Kenezy Gyula Campus | Varkonyi, Istvan | Hungary | Hajdu-Bihar, | Debrecen |
| Synexus Hungary - Budapest | Takats, Alajos | Hungary | Budapest | Budapest |
| Synexus Hungary Healthcare Service Ltd. - Debrecen | Nemes, Jozsef | Hungary | Hajdu-Bihar County | Debrecen |
| South-Pest Central Hospital - National Institute of Hematology | Makara, Mihaly | Hungary | Budapest | Budapest |
| High Tech Medical Kft. | Nyeky, Tamas | Hungary | Budapest | Budapest |
| The Chaim Sheba Medical Center | Ben-Ari, Ziv | Israel | Tel Aviv | Ramat Gan |
| Rambam Health Care Campus | Veitsman, Ella | Israel | Haifa | Bat Galim |
| Soroka Medical Center | Etzion, Ohad | Israel | Southern District | Be'er Sheva |
| Tel Aviv Sourasky Medical Center | Katchman, Helena | Israel | Gush Dan | Tel Aviv |
| Shaare Zedek Medical Center | Lalazar, Gadi | Israel | Jerusalem District | Jerusalem |
| Western Galilee Hospital-Nahariya | Nimer, Assy | Israel | Northern District | Nahariya |
| Carmel Medical Center | Zuckerman, Eli | Israel | Haifa District | Haifa |
| Hadassah University Hospital Ein Kerem | Safadi, Rifaat | Israel | Jerusalem District | Jerusalem |
| Ospedale Casa Sollievo della Sofferenza | Mangia, Alessandra | Italy | Foggia | San Giovanni Rotondo |
| Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino | Bugianesi, Elisabetta | Italy | Turin | Torino |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Lampertico, Pietro | Italy | MILANO | MILANO |
| University of Naples Federico II | Morisco, Filomena | Italy | Napoli | Napoli |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Petta, Salvatore | Italy | / | Palermo |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi | Azzaroli, Francesco | Italy | / | Bologna |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Miele, Luca | Italy | Roma | Roma |
| Maggiore della Carita University Hospital of Novara | Rigamonti, Cristina | Italy | Novara | Novara |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Valenti, Luca | Italy | MILANO | MILANO |
| Research and Gastroenterology Center | Ladron De Guevara Cetina, Alma Laura | Mexico | Ciudad de México | Cuauhtemoc |
| Dr. Jose Eleuterio Gonzalez University Hospital | Munoz Espinoza, Linda Elsa | Mexico | Nuevo Leon | Monterrey |
| Investigaciones Medicas Cisneros | Cisneros Garza, Laura Esthela | Mexico | Nuevo Leon | Monterrey |
| PanAmerican Clinical Research Mexico - Cuernavaca | Cabrera Alvarez, Guillermo | Mexico | Morelos | Cuernavaca |
| PanAmerican Clinical Research - Querétaro | Aguirre Valadez, Jonathan | Mexico | Querétaro | Queretaro |
| Centro de Investigacion Medico Biologica y Terapia Avanzada | Montano, Efrain | Mexico | Jalisco | Guadalajara |
| Medical Care and Research S.A. de C.V. | Mena Quintero, Axel | Mexico | Yucatan | Merida |
| Centro de Investigacion Y Gastroenterolgia, S.C. | Macias, Ricardo | Mexico | Ciudad de Mexico | Ciudad de Mexico |
| Hospital Universitario “Dr. Jose Eleuterio Gonzalez” (Servicio de Gastroenterologia) | Cortez, Carlos | Mexico | NUEVO LEON | MONTERREY |
| Consultorio de la Dra. Maria Sarai Gonzalez Huezo | Gonzalez, Maria | Mexico | Estado de Mexico | Metepec |
| Dr. Jose Eleuterio Gonzalez University Hospital (Department of Endocrinology) | Gonzalez, Jose | Mexico | NUEVO LEON | MONTERREY |
| Instituto de Seguridad Social del Estado de Mexico y Municipios | Guerrero, Jorge | Mexico | Estado de Mexico | Metepec |
| Oaxaca Site Management Organization S.C. | Cruz, Elio | Mexico | Oaxaca | Oaxaca |
| Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Toapanta, Liz | Mexico | Mexico city | Mexico city |
| Hospital Regional de Alta Especialidad de Zumpango | Martinez, Martha | Mexico | Estado de Mexico | Zumpango |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Flores, Nayelli | Mexico | Tlalpan | Ciudad de Mexico |
| Organismo Publico Descentralizado Hospital Juarez de Mexico | Mejia, Maria | Mexico | Ciudad de Mexico | Ciudad de Mexico |
| Erasmus Medisch Centrum | Brouwer, Willem | Netherlands | Zuid-Holland | Rotterdam |
| Universitair Medisch Centrum Utrecht | Van Erpecum, Karel | Netherlands | Utrecht | Utrecht |
| Ziekenhuis Bernhoven | Gisbertz, Ingrid | Netherlands | North Brabent | Uden |
| Elisabeth-TweeSteden Ziekenhuis | Laheij, Robert | Netherlands | North Brabent | Tilburg |
| Radboud Universitair Medisch Centrum | Drenth, Joost | Netherlands | Gelderland | Nijmegen |
| Amsterdam Universitair Medische Centra - Academisch Medisch Centrum | Holleboom, Adriaan (Onno) | Netherlands | Noord-Holland | Amsterdam |
| Franciscus Gasthuis & Vlietland | Roomer, Robert | Netherlands | Zuid-Holland | Rotterdam |
| Clinical Research Center Piotr Napora Medical Doctors Professional Partnership | Napora, Piotr | Poland | Dolnoslaskie | Wroclaw |
| ID Clinic | Janczewska, Ewa | Poland | Silesian Voivodeship | Myslowice |
| Centrum Medyczne Pratia - Katowice | Blach, Elzbieta | Poland | Slaskie | Katowice |
| Synexus - Czestochowa | Jamrozik-Kruk, Zofia | Poland | Slaskie | Czestochowa |
| Centrum Medyczne Synexus Gdansk | Cesarz, Marek | Poland | Pomorskie | Gdansk |
| Synexus - Gdynia | Orkwiszewska-Nalewajko, Anna | Poland | Pomorskie | Gdynia |
| Synexus - Katowice | Olszanecka-Glinianowicz, Magdalena | Poland | Slaskie | Katowice |
| Synexus - todZ | Ojrzanowski, Marcin | Poland | todzkie | todz |
| Synexus - Poznan | Kolodziejska, Elzbieta | Poland | Wielkopolskie | Poznan |
| Synexus - Warszawa | Ochnio, Malgorzata | Poland | Mazowieckie | Warszawa |
| Synexus - Wroclaw | Dwojak, Marek | Poland | Dolnoslaskie | Wroclaw |
| Tras-Os-Montes and Alto-Douro Hospital Center - S. Pedro Hospital | Presa Ramos, Jose | Portugal | Vila Real | Vila Real |
| Local Health Unit of Alto Minho - Santa Luzia Hospital | Araujo, Tarcisio | Portugal | Viana do Castelo | Viana do Castelo |
| North Lisbon University Hospital Center - Santa Maria Hospital | Cortez Pinto, Helena | Portugal | Lisboa | Lisboa |
| Hospital Pedro Hispano | Andrade, Filipe | Portugal | Senhora da Hora | Senhora da Hora |
| Senhora da Oliveira Hospital - Guimaraes | Magalhaes, Joana | Portugal | Braga | Guimaraes |
| Hospital de Braga | Rolanda, Carla | Portugal | Braga | Braga |
| University Hospital Center of Saint John | Macedo, Guilherme | Portugal | Porto | Porto |
| Synexus - Mediclinic Southern Africa - Constantiaberg | Rajabally, Muhammad Naayil | South Africa | Western Cape | Cape Town |
| Synexus - Helderberg Clinical Research Centre - Somerset West | Coetzer, Soritha | South Africa | Western Cape | Somerset West |
| Synexus Clinical Research SA- Watermeyer | Mkhize, Nontokozo | South Africa | Pretoria | Val-De-Grace |
| Sefako Makgatho Health Sciences University | Koto, Modise Zacharia | South Africa | Gauteng | Pretoria |
| Torrecardenas Hospital Complex | Casado Martín, Marta Maria | Spain | Almeria | Almeria |
| Hospital Universitario Miguel Servet | Bernal, Vanesa | Spain | Zaragoza | Zaragoza |
| Hospital Universitario Puerta de Hierro - Majadahonda | Calleja Panero, Jose Luis | Spain | Madrid | Majadahonda |
| Hospital de la Santa Creu i Sant Pau | Soriano Pastor, German | Spain | Barcelona | Barcelona |
| University Hospital Alcorcon Foundation | Fernandez Rodriguez, Conrado | Spain | Madrid | Alcorcon |
| Hospital Universitario Virgen de Valme | Serrano Romero, Mercedes | Spain | Sevilla | Sevilla |
| Hospital Germans Trias i Pujol | Morillas Cunill, Rosa | Spain | Barcelona | Barcelona |
| Gregorio Maranon General University Hospital | Ibanez Samaniego, Luis | Spain | Madrid | Madrid |
| Vall d'Hebron University Hospital | Vargas Blasco, Victor | Spain | Barcelona | Barcelona |
| General University Hospital Consortium of Valencia | Diago Madrid, Francisco Moises | Spain | Valencia | Valencia |
| Complejo Hospitalario de Pontevedra | Turnes Vazquez, Juan | Spain | Pontevedra | Pontevedra |
| Parc Tauli Health Corporation of Sabadell | Casas Rodrigo, Meritxell | Spain | Barcelona | Sabadell |
| Hospital Universitario Rio Hortega | Penas, Irene | Spain | Valladolid | Valladolid |
| University Clinical Hospital of Valencia | Escudero Garcia, Maria Desamparados | Spain | Valencia | Valencia |
| Complejo Asistencial Universitario de Leon | Jorquera Plaza, Francisco | Spain | Leon | Leon |
| Hospital Universitario Son Espases | Bonet Vidal, Maria Lucia | Spain | Balearic Islands | Palma de Mallorca |
| Hospital Clinico Universitario Lozano Blesa | Cortes Garcia, Luis | Spain | Zaragoza | Zaragoza |
| Santiago University Clinical Hospital | Molina Perez, Esther | Spain | La Coruna | Santiago de Compostela |
| Virgen del Rocio University Hospital | Romero Gómez, Manuel | Spain | / | Sevilla |
| Hospital Universitario Marques de Valdecilla | Crespo Garcia, Javier | Spain | Cantabria | Santander |
| University Clinic of Navarra - Madrid | DAvola, Delia | Spain | Madrid | Madrid |
| Hospital Clinic de Barcelona | Gines Gibert, Pere | Spain | Barcelona | Barcelona |
| Hospital Universitario Virgen de la Victoria | Tinahones, Francisco | Spain | Malaga | Malaga |
| Medical Center of Limited Liability Company Edelweiss Medics | Bilotkach, Oleksandra | Ukraine | Kyiv | Kyiv |
| Medical Center of Limited Liability Company Medbud-Clinic | Postol, Svitlana | Ukraine | Kyiv | Kyiv |
| Medical Center of Limited Liability Company Family Medicine Plus | Chupryna, Liudmyla | Ukraine | Kyiv | Kyiv |
| King's College Hospital NHS Foundation Trust | Agarwal, Kaushik (Kosh) | United Kingdom | England | London |
| Nottingham University Hospitals NHS Trust | Wilkes, Emilie | United Kingdom | England | Nottingham |
| Panthera Biopartners - North London | Ajaz, Saima | United Kingdom | England | North London |
| Panthera Biopartners - Manchester | Ramjee, Mahadev | United Kingdom | England | Manchester |
| Panthera Biopartners - Glasgow | Heydtmann, Mathis | United Kingdom | Scotland | Glasgow |
| Panthera Biopartners - Preston | Greer, Shaun | United Kingdom | England | Preston |
| Sheffield Teaching Hospitals NHS Foundation Trust | Al-Joudeh, Amer | United Kingdom | England | Sheffield |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Anstee, Quentin | United Kingdom | England | Newcastle-upon-Tyne |
| Barts Health NHS Trust | Alazawi, William | United Kingdom | England | London |
| Royal Surrey County Hospital NHS Foundation Trust | Pericleous, Marinos | United Kingdom | England | Surrey |
| WCG Pharmaseek - Allure Health | Soto, Efrain | United States | Texas | Friendswood |
| Prospective Research Innovations Inc. | Scarpino, David | United States | California | Rancho Cucamonga |
| University of Pittsburgh Medical Center (UPMC) - Center for Liver Diseases | Behari, Jaideep | United States | Pennsylvania | Pittsburgh |
| Kansas Medical Clinic - Gastroenterology | Challa, Shekhar | United States | Kansas | Topeka |
| Advanced Research Institute - New Port Richey | Freedland, Curtis | United States | Florida | New Port Richey |
| Texas Clinical Research Institute | Ghalib, Reem | United States | Texas | Arlington |
| Headlands - Centex Studies - Westfield | Bajwa, Ali | United States | Texas | Houston |
| Tandem Clinical Research LLC - Marrero Clinic | Reiss, Gary | United States | Louisiana | Marrero |
| Yale School of Medicine | Lim, Joseph | United States | Connecticut | New Haven |
| New England Center for Clinical Research (NECCR) | Olefson, Sidney | United States | Massachusetts | Fall River |
| Triwest Research Associates | Lipkis, Donald | United States | California | San Diego |
| Florida Research Institute | Sarkar, Souvik | United States | Florida | Lakewood Ranch |
| University of Kansas Medical Center Research Institute | Dunn, Winston | United States | Kansas | Fairway |
| ObjectiveHealth - Digestive Health Research of North Texas | Stagg, Joshua | United States | Texas | Wichita Falls |
| Bridgeport Hospital | Loeser, Caroline | United States | Connecticut | Bridgeport |
| Gastro Health - Fairfax | Tekola, Bezawit | United States | Virginia | Fairfax |
| Charlotte Gastroenterology and Hepatology - Randolph Road Office | Wilson, Jason | United States | North Carolina | Charlotte |
| Silicon Valley Research Institute | Trinh, Huy | United States | California | San Jose |
| University of Utah School of Medicine | Gallegos-Orozco, Juan | United States | Utah | Salt Lake City |
| Washington University School of Medicine in St. Louis | Korenblat, Kevin | United States | Missouri | St. Louis |
| Digestive Health Specialist of the Southeast - Dothan East | Tarwater, Samuel | United States | Alabama | Dothan |
| INTEGRIS Baptist Medical Center | Patel, Joykumar | United States | Oklahoma | Oklahoma City |
| ObjectiveHealth - Northeast GI Research | Myers, Matthew | United States | North Carolina | Concord |
| Mercy Medical Center - Mcauley Plaza | Thuluvath, Paul | United States | Maryland | Baltimore |
| Gastro Health - Annapolis | Epstein, Michael | United States | Maryland | Annapolis |
| Sensible Healthcare Clinical Research | Bowman, William Kelly | United States | Florida | Ocoee |
| University of Kentucky | Grigorian, Alla | United States | Kentucky | Lexington |
| Options Health Research | Tatum, Harvey | United States | Oklahoma | Tulsa |
| Pioneer Research Solutions | Velazquez, Francisco | United States | Texas | Houston |
| Carolina Digestive Diseases | Goldstein, Phillip | United States | North Carolina | Greenville |
| Research and Education Foundation of Atlanta Medical Center | Pearlman, Brian | United States | Georgia | Atlanta |
| Digestive Health Associates of Texas - Rockwall | Sarles, Harry | United States | Texas | Rockwall |
| NorthShore University HealthSystem | Billings, Liana | United States | Illinois | Evanston |
| SSM Health Saint Louis University Hospital | Tetri, Brent | United States | Missouri | Saint Louis |
| Grand Teton Research Group | Williams, Todd | United States | Idaho | Idaho Falls |
| Center for Advanced Gastroenterology - Main Office - Maitland | Quagliata, Joseph | United States | Florida | Maitland |
| Gastro Center of Maryland - Columbia | Rai, Rudrajit (Rudy) | United States | Maryland | Columbia |
| Veterans Affairs Pittsburgh Healthcare System - University Drive Campus | Shaikh, Obaid | United States | Pennsylvania | Pittsburgh |
| Centricity Research (IACT Health) | Steinbook, Michael | United States | Georgia | Columbus |
| Texas Liver Institute/American Research Corporation | Lawitz, Eric | United States | Texas | San Antonio |
| The Liver Institute at Methodist Dallas | Mantry, Parvez | United States | Texas | Dallas |
| University of Iowa Hospitals and Clinics | Sanchez, Antonio | United States | Iowa | Iowa City |
| Optimus U | Gonzalez Rojas, Yaneicy | United States | Florida | Miami |
| Arkansas Diagnostic Center & The Liver Wellness Center | Williams, Sr., Alonzo | United States | Arkansas | Little Rock |
| San Fernando Valley Health Institute LLC | London, Jeffrey | United States | California | Canoga Park |
| Advanced Medical Trials | Snook, Murray | United States | Texas | Georgetown |
| Froedtert and Medical College of Wisconsin | Saeian, Kia | United States | Wisconsin | Milwaukee |
| Saint Joseph's Hospital and Medical Center | Reynolds, Justin | United States | Arizona | Phoenix |
| Pinnacle Research Group | Kashyap, Pankaj | United States | Alabama | Anniston |
| ObjectiveHealth - North Alabama GI Research Center | Lockette, Jason | United States | Alabama | Huntsville |
| Pro Live Medical Research | Suarez, Rosa | United States | Florida | Miami |
| FOMAT Medical Research | Simon, Karen | United States | California | Camarillo |
| Rapid City Medical Center | Jones, Blake | United States | South Dakota | Rapid City |
| Digestive Healthcare of Georgia - Atlanta | Galambos, Michael | United States | Georgia | Atlanta |
| Summit - Covenant Metabolic Specialists - Sarasota | Neff, Guy | United States | Florida | Sarasota |
| Henry Ford Health System | Gonzalez, Humberto | United States | Michigan | Detroit |
| Louisiana Research Center - Central | Aguilar, Humberto | United States | Louisiana | Shreveport |
| National Institute of Clinical Research (NICR) | Doan, Ban | United States | California | Monterey Park |
| Genoma Research Group, Inc | Vento, Angel Omar | United States | Florida | Miami |
| WCG Pharmaseek - American Research Institute | Romero, Sandor | United States | Florida | Cutler Bay |
| USPA Advance Concept Medical Research Group | Macias, Francisco | United States | Florida | Miami |
| Sherman Clinical Research | Yusufzai, Irfanullah | United States | Texas | Sherman |
| Palmetto Research | Castaneda, Jorge | United States | Florida | Hialeah |
| Houston Methodist Hospital | Victor, David | United States | Texas | Houston |
| Research and Education, Inc. | Nguyen, Tuan | United States | California | San Diego |
| Athens Gastroenterology Association | Williams, Jeffrey | United States | Georgia | Athens |
| Gastroenterology Associates of Western Michigan | Coates, Allan | United States | Michigan | Wyoming |
| Emeritas Research Group | Gill, Satinder | United States | Virginia | Landsdowne |
| Flourish Boca Raton - Excel Medical Clinical Trials | Baum, Seth | United States | Florida | Boca Raton |
| Top Medical Research | Ruiz, Jose | United States | Florida | Cutler Bay |
| Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists | Tieu, Alan | United States | Virginia | Norfolk |
| AdventHealth Transplant Institute | Koteish, Ayman | United States | Florida | Orlando |
| Miami Dade Medical Research Institute | Puente, Orlando | United States | Florida | Miami |
| Mayo Clinic - Rochester | Abdelmalek, Manal | United States | Minnesota | Rochester |
| Accel Research Sites - Maitland | Heurich, Eva-Maria | United States | Florida | Maitland |
| Physicians' Research Options LLC | Jack, David | United States | Utah | Draper |
| Schiff Center for Liver Diseases | Schiff, Eugene | United States | Florida | Miami |
| Icahn School of Medicine at Mount Sinai | Villanueva, Augusto | United States | New York | New York |
| Digestive Disease Associates - Catonsville | Ravendhran, Natarajan | United States | Maryland | Catonsville |
| Stanford University Medical Center | Torok, Natalie | United States | California | Redwood City |
| Massachusetts General Hospital | Corey, Kathleen | United States | Massachusetts | Boston |
| Lucas Research | Lucas, Kathryn Jean | United States | North Carolina | Morehead City |
| Precision Research Institute - Chula Vista | Schaeffer, Cynthia | United States | California | Chula Vista |
| Arizona Liver Health - Tucson | Alkhouri, Naim | United States | Arizona | Tucson |
| Summit - Clinical Research Institute of Ohio | Tabbaa, Mousab | United States | Ohio | Westlake |
| Beth Israel Deaconess Medical Center - Liver Center | Lai, Michelle | United States | Massachusetts | Boston |
| Meritus Center for Clinical Research | Choudari, Chintamaneni | United States | Maryland | Hagerstown |
| Doral Medical Research | Diaz, Jorge L. | United States | Florida | Hialeah |
| Inova Fairfax Medical Campus | Clement, Stephen | United States | Virginia | Falls Church |
| Joan & Sanford I. Weill Medical College of Cornell University | Kumar, Sonal | United States | New York | New York |
| Gastroenterology Associates - Baton Rouge | McDonald, John | United States | Louisiana | Baton Rouge |
| Gastro Florida - Corporate | Glamour, Tejinder | United States | Florida | Clearwater |
| Gastroenterology Consultants - Ellington | Gastroenterology Consultants - Ellington | United States | Texas | Houston |
| Liver Specialists of Texas | Galati, Joseph | United States | Texas | Houston |
| Chevy Chase Clinical Research | Ali, Mohammed | United States | Maryland | Chevy Chase |
| Impact Research Institute - Waco | Gunn, Nadege | United States | Texas | Waco |
| Arizona Digestive Health - Sun City | Chokshi, Parag | United States | Arizona | Sun City |
| Duke University School of Medicine | Diehl, Anna Mae | United States | North Carolina | Durham |
| Virginia Commonwealth University | Luketic, Velimir | United States | Virginia | Richmond |
| Clinical Trials Services Corporation | Guevara Vazquez, Vladimir | United States | Florida | Miami |
| Gastro Health - Montgomery (8271) | Ravinuthala, Ravi | United States | Ohio | Cincinnati |
| University Hospitals Case Medical Center | Gholam, Pierre | United States | Ohio | Cleveland |
| Tampa General Hospital | Kemmer, Nyingi | United States | Florida | Tampa |
| Brooke Army Medical Center | Hollweg, Johanna | United States | Texas | Fort Sam Houston |
| Medical University of South Carolina | Rockey, Don | United States | South Carolina | Charleston |
| California Pacific Medical Center Research Institute | Merriman, Raphael | United States | California | San Francisco |
| Velocity Clinical Research (National Research Institute) - Westlake | Leibowitz, Mark | United States | California | Los Angeles |
| Boston Medical Center | Mohanty, Arpan | United States | Massachusetts | Boston |
| Vanderbilt University Medical Center | Scanga, Andrew | United States | Tennessee | Nashville |
| University of Virginia Health System | Caldwell, Stephen | United States | Virginia | Charlottesville |
| State University of New York - University at Buffalo | Chaudhuri, Ajay | United States | New York | Buffalo |
| Gastrointestinal Associates & Endoscopy Center - Flowood | Dotherow, Pierce | United States | Mississippi | Flowood |
| Metropolitan Gastroenterology Associates - Metairie | Catinis, George | United States | Louisiana | Metairie |
| Saint Luke's Hospital of Kansas City | Alba, Laura | United States | Missouri | Kansas City |
| Tranquil Clinical Research | Shah, Jignesh | United States | Texas | Webster |
| Florida Vascular Research | Guala, Pablo | United States | Florida | Miami |
| Sun Research Institute | Reyes, Leonel | United States | Texas | San Antonio |
| SKYCRNG - Quinn Healthcare | Quinn, Timothy | United States | Mississippi | Ridgeland |
| Care United Research | Mittal, Shilpi | United States | Texas | Forney |
| Bon Secours Liver Institute of Hampton Roads | Shiffman, Mitchell | United States | Virginia | Newport News |
| Velocity Clinical Research (National Research Institute) - Santa Ana | Vu, Julie | United States | California | Santa Ana |
| Regional Infectious Diseases and Infusion Center | Kamepalli, Ravi | United States | Georgia | LaGrange |
| Galen Research | Beyzer, Alexander | United States | Missouri | Chesterfield |
| Del Sol Research Management - Tucson East | Deeb, Fadi | United States | Arizona | Tucson |
| Summit - Velocity Clinical Research (National Research Institute) - Panorama City | Jenders, Robert | United States | California | Panorama City |
| GW Research | Wiener, Gregory | United States | California | Chula Vista |
| PanAmerican Clinical Research - US Headquarters | Romero, Christopher | United States | Texas | Brownsville |
| University of Michigan Health-West Hospital | Hassan, Ammar | United States | Michigan | Wyoming |
| JY Research Institute Inc. | Gonzalez, Nelson | United States | Florida | Cutler Bay |
| Quest Clinical Research | Bonacini, Maurizio | United States | California | San Francisco |
| Summit - Quality Research - San Antonio | Morin, Robert | United States | Texas | San Antonio |
| University of Chicago | Rinella, Mary | United States | Illinois | Chicago |
| Summit - Pinnacle Clinical Research - San Antonio | Rudraraju, Madhavi | United States | Texas | San Antonio |
| NAPA Research | Parikh, Naval | United States | Florida | Pompano Beach |
| Southeast Clinical Research Center | Perez, Pablo E. | United States | Georgia | Dalton |
| IMA Group - Clinical Research - Austin, Texas (f.k.a. Accelemed Research Institute) | Kim, Nomita | United States | Texas | Austin |
| Tampa Bay Medical Research | Bollepalli, Sureka | United States | Florida | Clearwater |
| American Research Centers of Florida | del Prado Rodriguez, Luis | United States | Florida | Pembroke Pines |
| Clinical Research Institute of Michigan | Fogel, Ronald | United States | Michigan | Chesterfield |
| Summit - Arizona Liver Health - Chandler | Kohli, Anita | United States | Arizona | Chandler |
| Oracle Clinical Research | Martinez, Linda | United States | Georgia | College Park |
| Coastal Research Institute LLC | Poulos, John | United States | North Carolina | Fayetteville |
| Summit - Arizona Liver Health - Peoria | Moore, Ann | United States | Arizona | Peoria |
| Summit - Palmetto Clinical Research | Grossman, Colby | United States | South Carolina | Summerville |
| Summit - Arkansas Gastroenterology | Wofford, Scott | United States | Arkansas | North Little Rock |
| Summit - Gastro One - Cordova | Younes, Ziad | United States | Tennessee | Cordova |
| Advanced Neuro Research Centers (ANRC) - Pellicano Drive | Gorospe, Emmanuel | United States | Texas | El Paso |
| Adobe Gastroenterology | Moussa, Sam | United States | Arizona | Tucson |
| Summit - Synergy Healthcare | Weston, Patrick | United States | Florida | Bradenton |
| ASHA Clinical Research - Munster LLC | Kesani, Mohan | United States | Indiana | Hammond |
| Richmond University Medical Center | Patel, Kavan | United States | New York | Staten Island |
| South Texas Research Institute (STRI) - Brownsville | Desai, Dimple P. | United States | Texas | Brownsville |
| South Texas Research Institute - Edinburg | Patil, Rashmee | United States | Texas | Edinburg |
| Centricity (Aventiv) Research - Columbus | Arora, Samir | United States | Ohio | Columbus |
| Summit - Pinnacle Clinical Research - Austin | Benun, Jacques | United States | Texas | Austin |
| MNGI Digestive Health - Northeast Minneapolis Clinic | Hanouneh, Ibrahim | United States | Minnesota | Minneapolis |
| Future Care Solution | Trueba, Pilar | United States | Florida | Miami |
| Combined Gastro Research LLC | Abshire, Stephen | United States | Louisiana | Lafayette |
| Velocity Clinical Research - Chula Vista (eStudySite - Chula Vista) | Waters, Michael | United States | California | Chula Vista |
| Summit - Liver Associates of Texas | Ankoma-Sey, Victor | United States | Texas | Houston |
| Gastroenterology Associates - Manassas | Choi, Myung | United States | Virginia | Manassas |
| Soma Clinical Trials | Elgouhari, Hesham | United States | Texas | Denison |
| Hi Tech and Global Research, LLC | Beato, Jorge | United States | Florida | Coral Gables |
| Life Medical Research Group | Fernandez, Sander | United States | Florida | Miami |
| D&H National Research Centers | Amaya, Jorge | United States | Florida | Miami |
| MedBio Trials | Bahrami, Michael | United States | Florida | Adventura |
| Summit - Fundación de Investigación de Diego | Ortiz-Lasanta, Grisell | United States | Puerto Rico | San Juan |
| Objective Health - Digestive Health Research of Central Texas | Ancha, Hanumantha | United States | Texas | Waco |
| Clinical Trial Management Services | Patel, Mahendra | United States | California | Thousand Oaks |
| ObjectiveHealth - ARcare Center for Clinical Research - Arkansas | Raghavan, Senthil | United States | Arkansas | Little Rock |
| Objective Health - ARcare Center for Clinical Research - Conway | Humphrey, Landon | United States | Arkansas | Conway |
| Great Lakes Gastroenterology Research - Mentor | Friedenberg, Keith | United States | Ohio | Mentor |
| GI Alliance-Texas Digestive Disease Consultants - Fort Worth - Downtown | Modi, Apurva | United States | Texas | Fort Worth |
| Objective Health - Birmingham Gastroenterology Associates | Dasher, Charles | United States | Alabama | Birmingham |
| Objective Health - GI Select Health Research, LLC | Khalid, Omer | United States | Virginia | Richmond |
| ObjectiveHealth - Mid-Atlantic GI Research | Mohi-Ud-Din, Raja | United States | Maryland | Greenbelt |
| Digestive Specialists - Dayton | Sherman, Michael | United States | Ohio | Dayton |
| Gastrointestinal (GI) Associates L.L.P. | Williams, Michael D. | United States | Missouri | Columbia |
| The Clinical Trials Network - Gastro Care Institute | Perumalsamy, Kumaravel | United States | California | Lancaster |
| Velocity Clinical Research - Austin | Zimmerman, Michael | United States | Texas | Cedar Park |
| Alpha Research Institute, LLC | Abate, Nicola | United States | Texas | Houston |
| ObjectiveHealth - Pensacola GI Research Center | Maley, Elizabeth | United States | Florida | Pensacola |
| Cadena Care Institute | Merkes, Kevin | United States | California | Poway |
| Galenus Group | Castillo-Nieves, Edgardo | United States | Florida | Lehigh Acres |
| Tandem Clinical Research GI - Houma | Fitton, Conar | United States | Louisiana | Houma |
| Clinovacare Medical Clinical Research Center | Boone, Tasha | United States | South Carolina | West Columbia |
| IMIC Research - International Medical Investigations Centers | Rodriguez, Miguel | United States | Florida | Palmetto Bay |
| Tandem Clinical Research LLC - Metairie Clinic | Fatakia, Adil | United States | Louisiana | Metairie |
| Eminat, LLC | Trujillo, Yaneth | United States | Florida | Plantation |
| Koncord Research - McAllen LLC | Echavarria, Mario | United States | Texas | McAllen |
| Summitt - Pinnacle Clinical Research - Georgetown | Benun, Jacques | United States | Texas | Georgetown |
| Gastro Health - Galloway | Hernandez, Maria | United States | Florida | Miami |
| Cure Clinical Research, LLC | Dandillaya, Ramprasad (Ram) | United States | California | Fountain Valley |
| Southwest Gastroenterology Associates | Jakiche, Antoine | United States | New Mexico | Albuquerque |
| Office of Franco Felizarta, MD | Felizarta, Franco | United States | California | Bakersfield |
| Florida Medical Clinic - Zephyrhills | Chami, Tawfik | United States | Florida | Zephyrhills |
| Heartland Medical Research | Iyer, Rajalakshmi | United States | Iowa | Clive |
| Tandem Clinical Research - New York Clinic | Hernandez, Lincoln | United States | New York | New York |
| Royal Free London NHS Foundation Trust | Tsochatzis, Emmanue | United Kingdom | England | London |
| Umberto I - Policlinico di Roma | Del Ben, Maria | Italy | Roma | Roma |
| Liver Institute Northwest | Kowdley, Kris | United States | Washington | Seattle |
| The Johns Hopkins Hospital | Hamilton, James | United States | Maryland | Baltimore |
| University of Rochester Medical Center | Huang, Jonathan | United States | New York | Rochester |
| University of Vermont Medical Center | Lidofsky, Steven | United States | Vermont | Burlington |
| University of California San Diego | Loomba, Rohit | United States | California | La Jolla |
| South Denver Gastroenterology - Swedish Medical Center Office | Kugelmas, Marcelo | United States | Colorado | Englewood |
| University Hospital of Dusseldorf | Qvartskhava, Natalia | Germany | Nordrhein-Westfalen | Dusseldorf |
| GI Alliance - Gastroenterology Associates of Florida - Wellington | Hurwitz, Lyle | United States | Florida | Wellington |
| The Ohio State University | Li, Na | United States | Ohio | Columbus |
| Inland Empire Liver Foundation | Kayali, Zeid | United States | California | Rialto |
| Kansas City Research Institute | Freilich, Bradley | United States | Missouri | Kansas City |
| Ospedale Civile di Baggiovara | Nascimbeni, Fabio | Italy | Modena | Modena |
| Cleveland Clinic Florida | Zervos, Xaralambos | United States | Florida | Weston |
| Houston Research Institute (HRI) | Noureddin, Mazen | United States | Texas | Houston |
| Capital Digestive Care Rockville | Stern, William | United States | Maryland | Rockville |
| Padua University Hospital Company | Cazzagon, Nora | Italy | Padova | Padova |
| Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond | Fuchs, Michael | United States | Virginia | Richmond |
| Liver Center of Texas | Mubarak, Abdullah | United States | Texas | Dallas |
| New York University Langone Gastroenterology Associates | Jacobson, Ira | United States | New York | New York |
| Northwestern University | Cheung, Amanda | United States | Illinois | Chicago |
| Sierra Clinical Research - Las Vegas | Sharma, Vishvinder | United States | Nevada | Las Vegas |
| GI Alliance - Bay Area Gastroenterology - Webster | Inamdar, Nikhil | United States | Texas | Webster |
| Gastroenterology Associates - Halton | Barnes, Matthew | United States | South Carolina | Greenville |
| Ohio Gastroenterology Group, Inc. - Olentangy Office | Gaible, Ryan | United States | Ohio | Dublin |
| Mayo Clinic in Arizona - Phoenix Campus | Lizaola-Mayo, Blanca | United States | Arizona | Phoenix |
| GI Alliance - Mansfield | Youssef, Moustafa | United States | Texas | Mansfield |
| Digestive and Liver Center of Florida - Orlando | Sheela, Harinath | United States | Florida | Orlando |
| Houston Methodist Research Institute | Khan, Rashid | United States | Texas | Houston |
| Connecticut GI - Bristol Gastroenterology Institute | Zakko, Salam | United States | Connecticut | Bristol |
| GI Alliance - Lubbock Digestive Disease Associates - Lubbock | Hughston, Adam | United States | Texas | Lubbock |
| Gastroenterology of the Piedmont, PA - Salem Office | Laura, Patwa | United States | North Carolina | Winston Salem |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 重庆医科大学附属第二医院伦理委员会 | 同意 | 2023-03-15 |
| 吉林大学第一医院伦理委员会 | 同意 | 2023-03-16 |
试验状态信息
试验状态
进行中-尚未招募
目标入组人数
国内: 175 ；
国际: 1200 ；
已入组例数
国内: 登记人暂未填写该信息；
国际: 481 ；
实际入组总例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：2021-08-19；
第一例受试者入组日期
国内：登记人暂未填写该信息；
国际：2021-11-20；
试验终止日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
