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
6.0
版本日期
2024-02-22
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：不允许在资格鉴定肝活组织检查前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），在肝活组织检查至基线访视（访视0）期间，剂量必须保持稳定： a) 胰高血糖素样肽-1受体激动剂（GLP1受体激动剂，包括组合药物）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 d) 抗肥胖治疗，至少6个月
- 对于接受标准#7 未涵盖的可能会影响安全性或有效性评估的合并用药的受试者（ GLP1（或组合）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），在基线访视（访视 0）前至少 3 个月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。
- 最近的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。
- 具有以下任何一项合成肝功能异常： ？ 白蛋白低于正常范围下限 ？ 国际标准化比率（INR）≥1.3（除非受试者正在使用抗凝剂） ？ 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。
- 在随机分组前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6个月内初次参加有组织的体重下降计划（例如Weight Watchers®,Jenny Craig®），或在研究72周内计划参加该计划或当前接受奥利司他治疗。
- 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）< 45 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）。
- 自身免疫相关： 任何自身免疫性肝病易感患者，包括： a）肝脏活检体征提示自身免疫性肝病（自身免疫性肝炎、免疫性胆管炎或重叠综合征） b）一级亲属有自身免疫性肝病家族史 c）自身免疫性甲状腺疾病 1. 已知诊断为自身免疫性甲状腺疾病 2. 使用甲状腺激素替代治疗，除非记录到原发性甲状腺功能不全的原因（例如由于甲状腺切除术、放射治疗等） 3. 与甲状腺功能检查（TSH、T4或游离T3）异常相关的自身免疫性抗体阳性 i. 抗甲状腺过氧化物酶抗体（TPO）或 ii. 抗TSH受体抗体（TRAb） d）有以下病史或筛选时以下检查结果呈阳性： 1. 抗核抗体（ANA）（1:320或更高稀释度） 2. 抗线粒体抗体（AMA） 3. 抗平滑肌抗体（ASMA）（1:320或更高稀释度） 4. 抗肝肾微粒体1型抗体（LKM1） 5. 抗肝细胞质1型抗体（LC1）
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 |
| 吉林大学第一医院伦理委员会 | 同意 | 2024-03-21 |
试验状态信息
试验状态
进行中-招募中
目标入组人数
国内: 175 ；
国际: 1200 ；
已入组例数
国内: 1 ；
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：2023-09-28；
国际：2021-08-19；
第一例受试者入组日期
国内：2023-12-12；
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 |
|---|
