ctr20192333 试验状态 进行中 首次公示信息日期...
TRANSCRIPT
登记号 CTR20192333 试验状态 主动终止
申请人联系人 刘伊雯 首次公示信息日期 2019-11-19
申请人名称 西安杨森制药有限公司
一、题目和背景信息
登记号 CTR20192333
相关登记号
药物名称 Pimodivir
药物类型 化学药物
临床申请受理号 JXHL1900011
适应症 企业选择不公示
试验专业题目 评价 Pimodivir联合标准疗法治疗有并发症风险的甲流非住
院患者的疗效和安全性的 III期、随机、双盲、安慰剂对照
研究。
试验通俗题目 Pimodivir在有并发症风险甲流非住院患者的疗效和安全性
研究。
试验方案编号 63623872FLZ3002 修正案 1
方案最新版本号 修正案 1
版本日期 2018-02-09
方案是否为联合用
药
企业选择不公示
二、申请人信息
申请人名称 西安杨森制药有限公司
联系人姓名 刘伊雯 联系人座机 021-33377535
联系人手机号 15921850139 联系人 Email [email protected]
联系人邮政地址 上海市-上海市-
邮政地址：上海市
徐汇区桂箐路 65
号 新研大厦 A楼 6
层
联系人邮编 200233
三、临床试验信息
1、试验目的
本研究的目的是评价 Pimodivir联合标准疗法（SOC）治疗与安慰剂联合 SOC治
疗，在甲型流感病毒感染且具有并发症风险的青少年、成人和老年非住院受试者
中的临床和病毒学获益。
2、试验设计
试验分类 安全性和有效性
试验分期 III期
设计类型 平行分组
随机化 随机化
盲法 双盲
试验范围 国际多中心试验
3、受试者信息
年龄 13岁(最小年龄)至 85岁(最大年龄)
性别 男+女
健康受试者 无
入选标准 1.至门诊就医，症状提示诊断急性流感，至少出现一种呼吸系统
症状并至少出现一种全身症状，如果在流感发作前没有出现上述
症状，那么它们的评分至少是“中度”，如果在流感发作前已经
出现上述症状（根据 ePRO设备上 Flu-iiQTM模块 1和之前存在症
状问卷的受试者评定），评分就要比之前更差。症状必须包括下
列分类： 1. 呼吸系统症状：咳嗽、咽喉痛、鼻塞；2. 全身症状：
头痛、身体酸痛、感觉发热、疲乏
2.症状发作后采用快速流感诊断试验（RIDT）或者基于 PCR的方
法（如果有）或其他快速分子诊断方法，检测甲型流感病毒感染
阳性。
3.筛选时不需要住院治疗。只要医生认为不需要住院，那么预期
在急诊室或医院留观＜24小时不算住院。
4.要在流感症状发作后≤72小时入组并启动研究药物治疗。
5.13-65岁（含）的受试者必须至少患有下列一种疾病：心血管
或脑血管疾病（包括充血性心脏病、慢性心力衰竭、冠状动脉疾
病或脑卒中；不包括孤立的高血压）；慢性肺病（例如哮喘、慢
性阻塞性肺疾病［COPD］或囊性纤维化）；因为疾病或药物导致
免疫系统功能障碍（例如人类免疫缺陷病毒［HIV］感染受试者、
癌症或慢性肝病或肾病受试者［肾损害＞3个月，定义为肾脏的
结构和功能异常，有或无 GFR下降，表现为病理学异常；或肾脏
损害标记物，包括血液或尿液成分出现异常，或影像学检查出现
异常］，或受试者长期使用全身性类固醇治疗。
排除标准 1.在首剂研究药物前 2周内，接受过 1剂以上流感抗病毒药物（例
如 OST或扎那米韦），或者任何剂量的利巴韦林，或者在筛选前
1天接受静脉内（IV）peramivir治疗。
2. 筛选前 30天（含）发作过不稳定型心绞痛或心肌梗死
3. 出现具有临床意义的心律失常、不能控制的不稳定型房性心律
失常、或持续的室性心律失常，或者具有尖端扭转型室性心动过
速综合征的危险因素。
4. 已知存在重度肝损害（Child Pugh C级肝硬化）或患有慢性丙
型肝炎病毒感染、正在接受丙型肝炎抗病毒治疗。
5. 研究者认为存在重度免疫功能缺陷（例如已知白细胞分化群 4+
［CD4+］计数＜200个细胞/mm3，中性粒细胞绝对计数＜750/mm3，
筛选前 2周内完成首个化疗疗程，筛选前 1年内干细胞移植病史，
肺移植病史）
6. 已知对 pimodivir 或其辅料过敏、发生过超敏反应或者不能耐
受
4、试验分组
试验药 序号 名称 用法
1. 中文通用名
Pimodivir：
用法用量：企业选择不公示
对照药 序号 名称 用法
1. 中文通用名：安慰剂 用法用量：薄膜衣片，口服，每次
两片，每日两次，连续服用五日
2. 中文通用名：达菲
（奥司他韦）
用法用量：胶囊 75mg/粒 口服，每
次 1粒，每日两次，连续服用五日
5、终点指标
主要终点指标
及评价时间
序
号
指标 评价时间 终点指标选择
1 主要终点是“至流感相关
症状消退的时间”，由患
者报告结局（PRO）测量
Flu-iiQTM进行评估。
基线至第 28天 有效性指标
次要终点指标
及评价时间
序
号
指标 评价时间 终点指标选择
1 发生不良事件受试者人数
评估安全性耐受性
至第 28天 安全性指标
2 发生实验室异常受试者人
数评估安全性耐受性
至第 28天 安全性指标
3 发生心电图异常受试者人
数评估安全性耐受性
至第 28天 安全性指标
4 发生生命体征异常受试者
人数评估安全性耐受性
至第 28天 安全性指标
5 住院受试者比例 至第 28天 有效性指标+
安全性指标
6 在治疗开始后发生流感并
发症的受试者比例
至第 28天 有效性指标
7 恢复到日常活动的时间 至第 28天 有效性指标
8 至发热消除的时间 至第 14天 有效性指标
9 全因死亡受试者人数 至第 28天 有效性指标+
安全性指标
10 Pimodivir血浆最大浓度 第 3天，第 6天
（第 5天晚上最
后一剂
Pimodivir用药
后 12小时）
有效性指标
11 Pimodivir血浆谷浓度 第 6天（第 5天
晚上最后一剂
Pimodivir用药
后 12小时）
有效性指标
12 达到 Pimodivir血浆最大
浓度的时间
第 3天，第 6天
（第 5天晚上最
后一剂
Pimodivir用药
后 12小时）
有效性指标
13 血浆浓度-时间曲线下面 第 3天，第 6天 有效性指标
积 给药后 0至 12小时
AUC（0-12）
（第 5天晚上最
后一剂
Pimodivir用药
后 12小时）
14 口感问卷测定的
Pimodivir在青少年受试
者中的可接受性
第 1天和第 5天
（晚上），或第
6天（早上）
有效性指标
15 吞咽问卷测定的
Pimodivir在青少年受试
者中的可接受性
第 1天和第 5天
（晚上），或第
6天（早上）
有效性指标
16 出现对 Pimodivir耐药的
受试者人数
至第 14天 有效性指标
17 至流感病毒转阴时间 至第 14天 有效性指标
18 病毒载量随时间变化 至第 14天 有效性指标
19 10项个体流感相关症状
中每一项的至消退时间，
由 PRO测量 Flu-iiQTM问
卷进行评估。
至第 28天 有效性指标
6、数据安全监
查 委 员 会
（DMC）
有
7、为受试者购
买试验伤害保
险
有
四、研究者信息
1、主要研究者信息
姓
名
王辰 学位 医学博士
职
称
中国工程院院士，主任医师，教授，博士生
导师
电话 010-64222969
Ema
il
[email protected] 邮政地址 北京市-北京市
-北京市朝阳区
樱花东街 2号
邮
编
100029 单位名称 中日友好医院
2、各参加机构信息
序
号
机构名称 （主要）研究者 国家 省（州）-城市
1 中日友好医院 王辰 中国 北京市 -北京
市
2 首都儿科研究所附属儿童
医院
朱春梅 中国 北京市 -北京
市
3 北京医院 李燕明 中国 北京市 -北京
市
4 广东省人民医院 高兴林 中国 广东省 -广州
市
5 联勤保障部队第九〇〇医
院
赖国祥 中国 福建省 -福州
市
6 上海市儿童医院 陆敏 中国 上海市 -上海
市
7 四川大学华西医院 梁宗安 中国 四川省 -成都
市
8 北京大学第三医院 李晓光 中国 北京市 -北京
市
9 中国人民解放军总医院
(301医院)
解立新 中国 北京市 -北京
市
10 浙江大学医学院附属第一
医院
周建英 中国 浙江省 -杭州
市
11 中山大学孙逸仙纪念医院 江山平 中国 广东省 -广州
市
12 复旦大学附属中山医院 宋元林 中国 上海市 -上海
市
13 青岛市市立医院 唐华平 中国 山东省 -青岛
市
14 河南省人民医院 张晓菊 中国 河南省 -郑州
市
15 南昌大学第一附属医院 张伟 中国 江西省 -南昌
市
16 哈尔滨医科大学附属第二
医院
陈宏 中国 黑龙江省 -哈
尔滨市
17 上海市同仁医院 张琴 中国 上海市 -上海
市
18 无锡市人民医院 赵寅滢 中国 江苏省 -无锡
市
19 贵州省人民医院 张湘燕 中国 贵州省 -贵阳
市
20 首都医科大学附属北京地
坛医院
徐艳利 中国 北京市 -北京
市
21 南方医科大学南方医院 孟莹 中国 广东省 -广州
市
22 上海市公共卫生临床中心 卢洪洲 中国 上海市 -上海
市
23 复旦大学附属华山医院 张文宏 中国 上海市 -上海
市
24 Hospital San Roque Ambasch,
German
Argentin
a
Cordoba
-Cordoba
25 Hospital Nuestra Senora
de la Misericordia
Minguez, Angel Argentin
a
Cordoba
-Cordoba
26 Instituto Medico
Platense
Alzogaray,
Maria Fernanda
Argentin
a
Buenos Aires
-La Plata
27 Hospital Italiano de La
Plata
Ramirez Borga,
Santiago
Argentin
a
Buenos Aires
-La Plata
28 Hospital Privado Centro
Medico de Cordoba S.A
Zarate, Abel Argentin
a
Cordoba
-Cordoba
29 Sanatorio Allende Bergallo,
Carlos Enrique
Argentin
a
Cordoba
-Cordoba
30 Sanatorio Britanico
S.A.
Nannini,
Esteban
Argentin
a
Santa Fe
-Rosario
31 Hospital Cordoba Riera,
Fernando Oscar
Argentin
a
Cordoba
-Cordoba
32 Sanatorio Juan XXIII Ariza, Horacio
Alberto
Argentin
a
Rio Negro
-General Roca
33 CEMIC Bonvehi, Pablo
Eduardo
Argentin
a
Ciudad
Autonoma
Buenos Aires
-Ciudad
Autonoma
Buenos Aires
34 Hospital Rawson David, Daniel
Omar
Argentin
a
Cordoba
-Cordoba
35 Instituto del Buen Aire Maillo, Martin Argentin
a
Santa Fe
-Santa Fe
36 Sanatorio del Oeste
Ituzaingo
Remolif,
Christian
Argentin
a
Buenos Aires
-Ituzaingo
37 Hospital Interzonal
General de Agudos Dr
Jose Penna
Ditondo, Juan
Carlos
Argentin
a
Buenos Aires
-Bahia Blanca
38 Mater Hospital Brisbane Griffin, Paul Australi
a
Queensland
-South
Brisbane
39 Northside Health Voloshyna,
Olga
Australi
a
New South
Wales -Coffs
Harbour
40 AKH - Medizinische
Universitaet Wien
Thalhammer,
Florian
Austria NA -Vienna
41 SMZ Süd - Kaiser Franz
Josef Spital Wien
Zoufaly,
Alexander
Austria NA -Wien
42 Calozet, Yvan Calozet, Yvan Belgium NA -Gribomont
43 BVBA Dr. Luc Capiau Capiau, Luc Belgium NA -Wetteren
44 Research Link Heijmans,
Stéphane
Belgium NA -Linkebeek
45 Mortelmans, Jaak Mortelmans, Belgium NA -Oostham
Jaak
46 De Meulemeester, Marc de
Meulemeester,
Marc
Belgium NA -Gozée
47 CHU Saint-Pierre De Wit,
Stephane
Belgium NA -Bruxelles
48 Institut Jules Bordet Aoun, Mickael Belgium NA -Bruxelles
49 Hopital Erasme Hites, Maya Belgium NA -Bruxelles
50 Testumed VZW Bouwen, Leen Belgium NA
-Tessenderlo
51 CCBR Brasil Centro de
Pesquisas e Análises
Clínicas Ltda.
Geller Wolff,
Priscila
Brazil Rio do Janeiro
-Rio do
Janeiro
52 CECIP - Centro de
Estudos Clínicos do
Interior Paulista
Yukiko Urakawa
Tokunaga,
Paula
Brazil Sao Paulo -Jaú
53 Fundacao José Luiz
Egydio Setúbal
de Oliveira
Junior,
Francisco
Ivanildo
Brazil Sao Paulo -Sao
Paulo
54 Santa Casa de
Misericórdia de Belo
Horizonte
de Faria
Freire,
Antonio
Tarcísio
Brazil Minas Gerais
-Belo
Horizonte
55 Pesquisare De Oliveira,
Carlos Alberto
Brazil Sao Paulo
-Santo André
56 Hospital Sao Vicente de
Paulo
Stobbe, Júlio
César
Brazil Rio Grande do
Sul -Passo
Fundo
57 CMiP - Centro Mineiro de
Pesquisa
de Souza,
Rodrigo Daniel
Brazil Minas Gerais
-Juiz de Fora
58 CEMEC – Centro
Multidisciplinar de
Estudos Clínicos
Francisco Pez,
Andréia Luísa
Brazil Sao Paulo -Sao
Bernardo do
Campo
59 Irmandade da Santa Casa
de Misericórdia de Sao
Paulo
Naaman
Berezin, Eitan
Brazil Sao Paulo -Sao
Paulo
60 Hospital Sao Lucas da
PUCRS
Ramos, Fabiano Brazil Rio Grande do
Sul -Porto
Alegre
61 Hospital de Clínicas de
Porto Alegre
Sprinz,
Eduardo
Brazil Rio Grande do
Sul -Porto
Alegre
62 Infection Control LTDA Starling, Brazil Minas Gerais
Carlos -Belo
Horizonte
63 HRPC - ULBRA Walker
Zettler,
Eduardo
Brazil Rio Grande do
Sul -Canoas
64 Diagnostic
Consultative Center II
- Sofia OOD
Loboshka-Bech
eva, Mariya
Bulgaria NA -Sofia
65 SHATPPD-Ruse EOOD Metev, Hristo Bulgaria NA -Ruse
66 Medical Center Popov, Todor Bulgaria NA -Sofia
67 MC Iliev, Ivo Bulgaria NA -Vidin
68 MHAT Lund, Borislav Bulgaria NA -Sofia
69 Military Medical
Academy - MHAT - Sofia
Tzvetkov,
Ventzislav
Bulgaria NA -Sofia
70 Medical Center Genova, Sonya Bulgaria NA -Sofia
71 MDHAT 'Dr. Stefan
Cherkezov', AD
Kolev,
Konstantin
Bulgaria NA -Veliko
Tarnovo
72 Acibadem City Clinic
DCC Tokuda EAD
Stoycheva,
Galina
Bulgaria NA -Sofia
73 Fifth MHAT - Sofia EAD Alexandrov,
Kalin
Bulgaria NA -Sofia
74 Recherche Clinique
Sigma Inc.
Chouinard, Guy Canada Quebec -Quebec
75 SKDS Research Inc. Henein, Sam Canada Ontario
-Newmarket
76 Commonwealth Medical
Clinic
O'Keefe,
Dennis
Canada Newfoundland
-Mount Pearl
77 Aggarwal and Associates
Ltd
Aggarwal,
Naresh
Canada Ontario
-Brampton
78 Weston Road Medical
Clinic
Goldman,
Howard
Canada Ontario
-Toronto
79 Dr. Anil K. Gupta
Medicine Professional
Corporation
Gupta, Anil Canada Ontario
-Toronto
80 Bluewater Clinical
Research Group Inc.
O'Mahony,
Michael
Canada Ontario
-Sarnia
81 Central Alberta
Research Clinic (CARe
Clinic)
Odendaal,
Morne
Canada Alberta -Red
Deer
82 Hospital de Ninos y
Cunas
Quilodran
Silva, Carlos
Nelson
Chile NA -Vina
83 Centro de Investigacion
del Maule
Silva
Orellana,
Chile NA -Talca
Rafael
84 Hospital El Pino Palma
Carvajal, Juan
Carlos
Chile NA -Santiago
85 Praktik Pb s.r.o. Sedivy, Jakub Czech
Republic
NA -Pribram
86 Saniga s.r.o. Vlasak, Zdenek Czech
Republic
NA -Sokolov
87 Nemocnice Kyjov p.o. Blazek, Josef Czech
Republic
NA -Kyjov
88 SANARE s.r.o. Matousová,
Alexandra
Czech
Republic
NA -Ceske
Budejovice
89 SARKAMED s.r.o. Koumarova,
Sarka
Czech
Republic
NA -Slany
90 ADMED s.r.o. Pavlasek,
Miroslav
Czech
Republic
NA -Ceske
Budejovice
91 Family Doctors Rauam &
Gavronski
Rauam, Liivia Estonia NA -Tartu
92 Private GP Ilme Last Last, Ilme Estonia NA -Paide
93 Vee Family Doctor`s
Center OY
Alt, Ingrid Estonia NA -Paide
94 Pirita Family Doctors
Centre
Arbeiter, Kaja Estonia NA -Tallinn
95 Merelahe Family Doctors
Centre
Lanno, Riin Estonia NA -Tallinn
96 Oü Innomedica Talli, Jaak Estonia NA -Tallinn
97 Centre Hospitalier
Intercommunal de
Créteil
Epaud, Ralph France Val de Marne
-Creteil cedex
98 CHU Nantes - Hotel Dieu Cattin,
Guillaume
France Loire
Atlantique
-Nantes Cedex
1
99 Hopital Bichat - Claude
Bernard
Yazdanpanah,
Yazdan
France Paris -Paris
Cedex 18
100 Centre Hospitalier Agen Fort,
Pierre-Arnaud
France Lot et Garonne
-Agen cedex 9
101 CHU de Grenoble -
Hopital Albert
Michallon
Stahl,
Jean-Paul
France Isere -La
Tronche
102 Hopital Bichat - Claude
Bernard
Casalino,
Enrique
France Paris -Paris
cedex 18
103 Hopitaux Pediatriques
de Nice CHU-Lenval
Haas, Herve France Pas de Calais
-Nice
104 Hopital Cochin Launay, Odile France Paris -Paris
cedex 14
105 Centre Hospitalier
Départemental Les
Oudairies
Frey, Jérome France Vendee -La
Roche S/ Yon
Cedex 9
106 Jung, Thomas Jung, Thomas Germany Baden
Wuerttemberg
-Deggingen
107 Gemeinschaftspraxis
Dr. Klein/ Minnich
Klein,
Christiane
Germany Bayern
-Kuenzing
108 Gemeinschaftspraxis
Dr. Taeschner / Dr.
Bonigut
Taeschner,
Heidrun
Germany Sachsen
-Leipzig
109 Universitaetsklinikum
Giessen und Marburg
GmbH Standort Giessen
Herold,
Susanne
Germany Hessen
-Giessen
110 MECS GmbH Cottbus Kaessner,
Frank
Germany Brandenburg
-Cottbus
111 Universitaetsklinikum
Erlangen
Harrer, Thomas Germany Bayern
-Erlangen
112 Tudogyogyintezet
Torokbalint
Laki, Istvan Hungary NA
-Torokbalint
113 Medifarma-98 Kft. Zilahi, Zsolt Hungary NA
-Nyiregyhaza
114 Universitaetsklinikum
Koeln
Faetkenheuer,
Gerd
Germany Nordrhein
Westfalen
-Koeln
115 Futurenest Klinikai
Kutato Kft.
Hajdu,
Gabriella
Hungary NA -Miskolc
116 Strazsahegy Medicina
Bt.
Kajetan,
Miklos
Hungary NA -Budapest
117 BORBANYA PRAXIS Kft. Vasas, Szilard Hungary NA
-Nyiregyhaza
118 DRC Gyogyszervizsgalo
Kozpont Kft.
Pauer, Jozsef Hungary NA
-Balatonfured
119 DRC Zirc Peterfai, Eva Hungary NA -Zirc
120 DRC Szentendre Hasitz, Agnes Hungary NA -Szentendre
121 Obudai Egeszsegugyi
Centrum Kft.
Danos, Peter Hungary NA -Budapest
122 DRC Zamardi Literati-Nagy
, Botond
Hungary NA -Zamardi
123 Bugat Pal Korhaz Sipos, Valeria Hungary NA -Gyongyos
124 Clinexpert Kft. Urban,
Veronika
Hungary NA -Budapest
125 Szent Janos Korhaz es
Eszak-budai Egyesitett
Korhazak
Vasas, Szilvia Hungary NA -Budapest
126 Pestszentimrei
Gyermekrendelo
Batta, Ildiko Hungary NA -Budapest
127 Mohacsi Korhaz Papp, Marta Hungary NA -Mohacs
128 M S Ramaiah Memorial
Hospital
Kulkarni,
Sanjay
India Karnataka
-Bangalore
129 Sir Ganga Ram Hospital Gogia, Atul India Delhi -New
Delhi
130 S. R. Kalla Memorial
Gastro & General
Hospital
Agarwal,
Avinash
India Rajasthan
-Jaipur
131 Unique Hospital Gami, Samir India Gujarat -Surat
132 BAPS Pramukhswami
Hospital
Koradia,
Parshottam
India Gujarat -Surat
133 Siddhi Hospital Mutha,
Abhinandan
India Maharashtra
-Nashik
134 BLK Super Specialty
Hospital
Nayar, Sandeep India Delhi -New
Delhi
135 Midland Healthcare &
Research Center
Singh, Bhanu India Uttar Pradesh
-Lucknow
136 Kasturba Medical
College
Varma,
Muralidhar
India Karnataka
-Manipal
137 Rajiv Gandhi Institute
of Medical Sciences
Naik, Sunil India Andhra Pradesh
-Srikakulam
138 Lifepoint
Multispecialty
Hospital
Nikalje,
Rajkumar
India Maharashtra
-Pune
139 Shree Giriraj
Multispeciality
Hospital
Thakker,
Mayank
India Gujarat
-Rajkot
140 Suretech Hospital and
Research Centre Limited
Jaiswal,
Nirmal
India Maharashtra
-Nagpur
141 Sahyadri Specialty
Hospital
Patwardhan,
Kapil
India Maharashtra
-Pune
142 Barzilai MC Maayan, Shlomo Israel NA -Ashkelon
143 Chaim Sheba Medical
Center
Rahav, Galia Israel NA -Ramat Gan
144 Bnai Zion Medical
Center
Schiff, Elad Israel NA -Haifa
145 Ziv Medical Center Hussein,
Osamah
Israel NA -Safed
146 Galilee Medical Center Nimer, Assy Israel NA -Nahariya
147 Kaplan Medical Center Fink, Gershon Israel NA -Rechovot
148 Azienda Ospedaliera di
Perugia Ospedale S.
Maria della
Misericordia
Esposito,
Susanna
Italy Perugia
-Perugia
149 Azienda Socio Sanitaria
Territoriale di Monza
(Presidio San Gerardo)
Migliorino,
Guglielmo
Marco
Italy Milano -Monza
150 A.O.U. Policlinico di
Modena
Mussini,
Cristina
Italy Modena -Modena
151 Azienda Socio Sanitaria
Territoriale Niguarda
(Grande Ospedale
Metropolitano
Niguarda)
Puoti, Massimo Italy Milano -Milano
152 Azienda Ospedaliera
Universitaria
Integrata Verona
(Ospedale Borgo Roma)
Biban, Paolo Italy Verona -Verona
153 Chungbuk National
University Hospital
Jeong, Hye Won Korea,
Republic
of
Chungcheongbu
k-do
-Cheongju-si
154 Hallym University
Kangnam Sacred Heart
Hospital
Lee, Jacob Korea,
Republic
of
NA -Seoul
155 Hallym University
Dongtan Sacred Heart
Hospital
Woo, Heung
Jeong
Korea,
Republic
of
Gyeonggi-do
-Hwaseong-si
156 Yonsei University Wonju
Severance Christian
Hospital
Kim, Hyo-Youl Korea,
Republic
of
Gyeonggi-do
-Wonju-si
157 Korea University Guro
Hospital
Kim, Woo-Joo Korea,
Republic
of
NA -Seoul
158 Inha University
Hospital
Lee, Jin Soo Korea,
Republic
of
NA -Incheon
159 The Catholic University
of Korea, Incheon St.
Mary's Hospital
Ahn, Joong
Hyun
Korea,
Republic
of
NA -Incheon
160 Korea University Anam
Hospital
Sohn,
Jang-Wook
Korea,
Republic
of
NA -Seoul
161 Korea University Ansan Park, Dae-Won Korea, Gyeonggi-do
Hospital Republic
of
-Ansan-si
162 The Catholic University
of Korea, St. Vincent's
Hospital
Wie,
Seong-Heon
Korea,
Republic
of
Gyeonggi-do
-Suwon-si
163 Asan Medical Center Woo, Jun Hee Korea,
Republic
of
NA -Seoul
164 Dong-A University
Hospital
Jung, Dong Sik Korea,
Republic
of
NA -Pusan
165 Konkuk University
Medical Center
Yoo, Kwang Ha Korea,
Republic
of
NA -Seoul
166 OLVI Medical Centre Mitrofanova,
Lilita
Latvia NA -Daugavpils
167 Medical Practice BINI Borsa, Ludmila Latvia NA -Ventspils
168 Clinic of GP A.Lasmanis Lasmanis,
Andris
Latvia NA -Riga
169 S. Boreiko Doctor`s
Practice
Boreiko,
Silvija
Latvia NA -Ogre
170 Children`s Clinical
University Hospital
Zavadska, Dace Latvia NA -Riga
171 Meissana LLC Cebere, Inese Latvia NA -Liepaja
172 Dr. R. Eglite`s Private
practice
Eglite, Ruta Latvia NA -Kuldiga
173 Dr Liga Kozlovska
Family Doctor Practice
Kozlovska,
Liga
Latvia NA -Balvi
174 Health Centre 4 Adijane, Elita Latvia NA -Riga
175 Baiba Bake GP practice Bake, Baiba Latvia NA -Jelgava
176 Inese Petrova General
Practitioner Practice
Petrova, Inese Latvia NA -Tukums
177 Siauliai Republican
Hospital, Public
Institution
Kausas, Aidas Lithuani
a
NA -Siauliai
178 Vilnius University
Hospital Santaros
Klinikos, Public
Institution
Venceviciene,
Lina
Lithuani
a
NA -Vilnius
179 Inmedica, JSC Kucinskiene,
Alina
Lithuani
a
NA -Kaunas
180 Inlita, JSC, Lazdynai
KTC (clinical trial
site)
Grigiene,
Giedre
Lithuani
a
NA -Vilnius
181 Auki Sveikas Kalasuniene,
Rutele
Lithuani
a
NA -Kaunas
182 Inlita, JSC, Center of
Santaros Clinical
Trials
Radzisauskien
e, Daiva
Lithuani
a
NA -Vilnius
183 Saules Seimos Medicinos
Centras, JSC
Urboniene,
Audrone
Lithuani
a
NA -Kaunas
184 Klinik Kesihatan Kuang Chang, Li
Cheng
Malaysia Selangor
-Kuang
185 Hospital Miri Fam, Tem Lom Malaysia Sarawak -Miri
186 Hospital Taiping Cheah, Wee
Kooi
Malaysia Perak -Taiping
187 Klinik Kesihatan Cheras
Baru
Wong, Ping Foo Malaysia Kuala Lumpur
-Cheras Baru
188 Hospital Cardiologica
Aguascalientes
Marquez Diaz,
Francisco
Mexico Aguascaliente
s
-Aguascalient
es
189 Clinical Trials Mexico
S.A. de C.V.
Escalante
Otero, Miguel
Angel
Mexico Hidalgo
-Pachuca de
Soto
190 Centro Medico Jojutla Cruz Valdez,
Aurelio
Mexico Morelos
-Jojutla de
Juárez
191 Hospital Infantil de
Mexico Federico Gomez
Moreno
Espinosa,
Sarbelio
Mexico Distrito
Federal
-Mexico
192 Universidad Autonoma de
Nuevo Leon, Hospital
Universitario Dr. Jose
Eleuterio Gonzalez
Rendon Perez,
Luis Adrian
Mexico Nuevo León
-Monterrey
193 Antiguo Hospital Civil
de Guadalajara Fray
Antonio Alcalde
Rodriguez
Noriega,
Eduardo
Mexico Jalisco
-Guadalajara
194 Centro de Investigacion
Medico Biologica y
Terapia Avanzada
(CIMBYTA)
Montano
Gonzalez,
Efrain
Mexico Jalisco
-Guadalajara
195 Centro para el
Desarrollo de la
Medicina y de
Asistencia Medica
Especializada S.C.
Urquidez
Bazua, Edgar
Mexico Sinaloa
-Culiacan
196 Hospital Civil de Rodriguez Mexico Jalisco
Guadalajara Dr. Juan I.
Menchaca
Gonzalez,
Daniel
-Guadalajara
197 Huisartsenpraktijk Top Top, Peter Netherla
nds
NA
-Zwijndrecht
198 Huisartsenpraktijk
Mangal
Mangal,
Radjesh
Netherla
nds
NA -Den Haag
199 Huisartsenpraktijk
Zijtregtop
Zijtregtop,
Ton
Netherla
nds
NA -Rotterdam
200 Wellington Hospital Taylor, James New
Zealand
NA -Wellington
201 Lakeland Clinical
Trials
Williams,
Michael
New
Zealand
NA -Rotorua
202 Culloden Research Ltd Sheahan,
Davitt
New
Zealand
NA -Papamoa
203 Southern Clinical
Trials - Remuera
Murray,
Phillipa
New
Zealand
NA -Auckland
204 Kuang Tien General
Hospital
Chen,
Chun-Chih
People's
Republic
of China
Taiwan
-Taichung City
205 Taipei Medical
University - Shuang Ho
Hospital, Ministry of
Health and Welfare
Liu,
Yung-Ching
People's
Republic
of China
Taiwan -New
Taipei City
206 Taipei Municipal
Wanfang Hospital
Managed by Taipei
Medical University
Ou, Tsong-Yih People's
Republic
of China
Taiwan -Taipei
207 Taipei Medical
University Hospital
Su, Chien-Tien People's
Republic
of China
Taiwan -Taipei
208 National Taiwan
University Hospital
Huang, Li-Min People's
Republic
of China
Taiwan -Taipei
209 Hospital Maria
Auxiliadora
De los Rios,
Jorge
Peru NA -Lima
210 Clinica Internacional LLerena
Zegarra,
Eneyda
Giuvanela
Peru NA -Lima
211 Cliniica Sanna San
Borja
Felix
Hinojosa,
Efrain Ciro
Peru NA -Lima
212 Clinica Peruano
Americana S.A
Camacho, Luis Peru NA -Trujillo
213 ETG Lodz Mordaka,
Robert
Poland NA -Lodz
214 Powiatowe Centrum
Medyczne w Wolowie Sp. z
o.o.
Kozina, Maciej Poland NA -Brzeg
Dolny
215 Centrum Badan
Klinicznych Piotr
Napora Lekarze Spolka
Partnerska
Napora, Piotr Poland NA -Wroclaw
216 Centrum Medyczne w
Lancucie Sp.z o.o.
Plesniak,
Robert
Poland NA -Lancut
217 Gabinet Lekarski
Pediatryczno-Alergolog
iczny
Bukowczan,
Marcin
Poland NA -Sucha
Beskidzka
218 Malopolskie Centrum
Alergologii
Bederska,
Malgorzata
Poland NA -Krakow
219 LLC Nilk,
Rostislav
Russian
Federati
on
NA
-Saint-Peters
burg
220 Federal State Education
Institition of Higher
Education Kazan
(Privolzhsky) Fedral
University
Fassakhov,
Rustem
Russian
Federati
on
NA -Kazan
221 LLC Pak, Tatiana Russian
Federati
on
NA -St.
Petersburg
222 State Autonomous
Institution of
Healthcare of Yaroslavl
region
Khokhlov,
Alexander
Russian
Federati
on
NA -Yaroslavl
223 FSBI Zubkova,
Tatiana
Russian
Federati
on
NA
-Saint-Peters
burg
224 Limited Liability
company
Unger, Maria Russian
Federati
on
NA -Omsk
225 State Autonomous
Healthcare Institution
of Yaroslavl Region
Clinical Hospital No. 3
Noskov, Sergey Russian
Federati
on
NA -Yaroslavl
226 LLC Outpatient
department of Private
Security Guards and
Popov, Valeriy Russian
Federati
on
NA
-Saint-Peters
burg
Detectives
227 Siberian State Medical
University
Starovoytova,
Elena
Russian
Federati
on
NA -Tomsk
228 Nemocnica s
poliklinikou S. Kukuru
Michalovce, a.s.
Zamba, Stefan Slovakia NA -Michalovce
229 ALERSA, s.r.o. Safcakova,
Daniela
Slovakia NA -Kosice
230 Plucna ambulancia
Hrebenar, s.r.o.
Hrebenar,
Slavomir
Slovakia NA -Spisska
Nova Ves
231 Nemocnica arm. generala
L. Svobodu Svidnik,
a.s.,
Pytliak, Marek Slovakia NA -Svidnik
232 Dr A Jacovides Clinical
Trials Inc.
Jacovides,
Andrew
South
Africa
Gauteng
-Midrand
233 Abdullah, IA Abdullah,
Ismail
South
Africa
KwaZulu-Natal
-Durban
234 Botho ke Bontle Health
Services
Mogashoa,
Mokgadi
South
Africa
Gauteng
-Pretoria
235 Pillai, P Pillai,
Perumal
South
Africa
KwaZulu-Natal
-Durban
236 Queenswood Clinical
Trial Centre
Fulat,
Muhammed
South
Africa
Gauteng
-Pretoria
237 CRISMO Bertha Gxowa
Research Centre
Mamba,
Musawenkosi
South
Africa
Gauteng
-Johannesburg
238 Wits Clinical Research Badat, Aysha South
Africa
Gauteng
-Johannesburg
239 Emmed Research Breedt,
Johannes
South
Africa
Gauteng
-Pretoria
240 Limpopo Clinical
Research Initiative
Fouche, Leon South
Africa
Limpopo
-Thabazimbi
241 Janari, EL Janari, Emlyn South
Africa
Western Cape
-Cape Town
242 Newtown Clinical
Research
Mitha, Essack South
Africa
Gauteng
-Johannesburg
243 Precise Clinical
Solutions (Pty) Ltd
Naidoo,
Visvakuren
South
Africa
KwaZulu-Natal
-Durban
244 Aliwal Shoal Medical
Centre
Padayachee,
Trevenesan
South
Africa
KwaZulu-Natal
-Umkomaas
245 Into Research Siebert, Heidi South
Africa
Gauteng
-Pretoria
246 Medicross Lyttelton Engelbrecht,
Ingrid
South
Africa
Gauteng
-Pretoria
247 Randles Road Medical
Centre
Govind, Uttam South
Africa
KwaZulu-Natal
-Durban
248 Johese Clinical
Research
Greyling,
Mario
South
Africa
Gauteng
-Pretoria
249 Josha Research Lombaard,
Johannes
South
Africa
Free State
-Bloemfontein
250 Dr AA Mahomed Medical
Centre
Mahomed, Akbar South
Africa
Mpumalanga
-Moloto
251 Moriana Clinical
Research
Ntsepe, Lebeko South
Africa
Free State
-Brandfort
252 Global Clinical
Research SA
Olivier,
Pieter
South
Africa
KwaZulu-Natal
-Durban North
253 Uhuru Clinical Trial
Centre
Patel,
Pradipkumar
South
Africa
Western Cape
-Cape Town
254 Peermed Clinical Trial
Centre
Pillay-Ramaya
, Larisha
South
Africa
Gauteng
-Kempton Park
255 Sebastian, Peter Sebastian,
Peter
South
Africa
KwaZulu-Natal
-Durban
256 Drs Dindar and Partners Dindar, Fareed South
Africa
Mpumalanga
-Breyten
257 Clinteam Vaal Clinical
Trial Centre
Essack, Yakub South
Africa
Gauteng -Van
der Bijl
258 Smartmed Research
Centre
Gani, Mashra South
Africa
Eastern Cape
-Port
Elizabeth
259 DJW Research Jurgens, Jaco South
Africa
Gauteng
-Krugersdorp
260 Reddy, J Reddy, Jeevren South
Africa
KwaZulu-Natal
-Durban
261 Endocare Research Schmidt,
Stephen
South
Africa
Western Cape
-Cape Town
262 Jongaie Research de Jong, Douwe South
Africa
Gauteng
-Pretoria
263 Cardiology Clinical
Research
Kapp, Cornelia South
Africa
Gauteng
-Alberton
264 Hospital Universitario
Clinico San Carlos
Estrada Perez,
Vicente
Spain Madrid -Madrid
265 Hospital Universitario
San Cecilio
Hernandez
Quero, Jose
Spain Granada
-Granada
266 Hospital Universitario
La Paz
Calvo,
Cristina
Spain Madrid -Madrid
267 Hospital Alvaro
Cunqueiro
Crespo Casal,
Manuel
Spain Pontevedra
-Vigo
268 Hospital Universitario Lalueza Spain Madrid -Madrid
12 de Octubre Blanco,
Antonio
269 Complejo Hospitalario
Universitario de
Santiago
Martinon
Torres,
Federico
Spain La Coruna
-Santiago de
Compostela
270 Hospital Universitario
de La Princesa
de los Santos,
Ignacio
Spain Madrid -Madrid
271 Hospital General
Universitario de Elche
Masia Canuto,
Marie del Mar
Spain Alicante
-Elche
272 Hospital Universitario
Virgen de las Nieves
Pasquau Liano,
Juan
Spain Granada
-Granada
273 Hospital Universitario
12 de Octubre
Rojo Conejo,
Pablo
Spain Madrid -Madrid
274 Hospital Universitario
Madrid Montepríncipe
Barberan, Jose Spain Madrid
-Boadilla del
Monte
275 Akardo MedSite Olsson, ake Sweden NA -Stockholm
276 Akademiska Sjukhuset Pauksens,
Karlis
Sweden NA -Uppsala
277 Skanes
Universitetssjukhus
Nilsson, Anna Sweden NA -Malmo
278 Norrlands
Universitetssjukhus
Rasmuson,
Johan
Sweden NA -Umea
279 Bumrungrad
International Hospital
Anekthananon,
Thanomsak
Thailand Bangkok
-Wattana
280 Siriraj Hospital Chayakulkeere
e, Methee
Thailand Bangkok
-Bangkok
281 Bamrasnaradura
Infectious Disease
Institute
Manosuthi,
Weerawat
Thailand Nonthaburi
-Muang
282 Vaccine Trial Centre,
Faculty of Tropical
Medicine, Mahidol
University
Pitisuttithum
, Punnee
Thailand Bangkok
-Ratchathewi
283 Dicle University,
Medical Faculty
Celen, Mustafa
Kemal
Turkey NA -Diyarbakir
284 Hacettepe University
Medical Faculty
Kara, Ates Turkey NA -Ankara
285 Adnan Menderes Univ.
Med. Fac.
Sakarya,
Serhan
Turkey NA -Aydin
286 Karadeniz Tecnical Uni.
Med. Fac.
Koksal,
Iftihar
Turkey NA -Trabzon
287 Kocaeli Universitesi
Tip Fakultesi
Cetin Akhan,
Sila
Turkey NA -Kocaeli
288 Uludag University
Medical Faculty
Kazak, Esra Turkey NA -Bursa
289 Hacettepe University
Medical Faculty
Unal, Serhat Turkey NA -Ankara
290 Poltava Regional
Clinical Infectious
Hospital Dept of
Diagnostics HSEIU
Ukrainian Medical
Stomatolog
Dubyns'ka,
Galyna
Ukraine NA -Poltava
291 Med San Unit PJSC
Kharkiv Tractor Plant
Dept of Ther KMA PGE
Korzh, Oleksii Ukraine NA -Kharkiv
292 Oleksandrivska
Clinical Hospital of
Kyiv
Minova,
Lyudmyla
Ukraine NA -Kyiv
293 CCH #1 Vinnytsia
M.I.Pyrogov NMU Ch of
Infectious Diseases
Moroz, Larysa Ukraine NA -Vinnytsia
294 Odesa City Municipal
Institution Polyclinic
#2#N/A
Telyatnikova,
Zinaida
Ukraine NA -Odesa
295 Bodey Medical Centre Tomkinson,
Stephen
United
Kingdom
Greater
Manchester
-Manchester
296 West Timperley Medical
Centre
Stratford
Smith, Philip
United
Kingdom
Greater
Manchester
-Manchester
297 Northenden Group
Practice
Kanumilli,
Naresh
United
Kingdom
Greater
Manchester
-Bolton
298 Barlow Medical Centre Allcock,
Damian
United
Kingdom
Greater
Manchester
-Manchester
299 Swan Lane Medical
Centre
Nixon, Paul United
Kingdom
Lancashire
-Bolton
300 Center for Clinical
Trials, LLC
Mangune, Edwin United
States
California
-Paramount
301 ACRC Trials Schultz, Rita United
States
Texas -Austin
302 J. Lewis Research Inc.-
Foothill Family Clinic
South
Coleman,
Stephen
United
States
Utah -Draper
303 Health Concepts Beasley, United South Dakota
Richard States -Rapid City
304 The Community Research
of South Florida
Carpio, Jose United
States
Florida
-Hialeah
305 J. Lewis Research Inc.-
Foothill Family Clinic
South
Christensen,
Shane
United
States
Utah -Salt
Lake City
306 Preferred Primary Care
Physicians, Inc.
Gates, Michael United
States
Pennsylvania
-Pittsburg
307 Hickory Research
Center.
Stern, Thomas United
States
North Carolina
-Hickory
308 HIRG, LLC dba Health
Innovation Research
Group
Dao, Timothy United
States
Texas
-Arlington
309 Clinical Trials
Management, LLC
Dulitz, David United
States
Louisiana
-Metairie
310 Vita Health and Medical
center
Labissiere,
Jean-Claude
United
States
Florida
-Tamarac
311 Buckeye Health and
Research
Florea, Robert United
States
Ohio -Columbus
312 Centennial Medical
Group, PC
Geller, Steven United
States
Maryland
-Elkridge
313 Moonshine Research
Center, Inc
Ramos, Faride United
States
Florida -Doral
314 Scottsboro Quick Care
Clinic
Ismail, Younus United
States
Alabama
-Scottsboro
315 J. Lewis Research, Inc.
- Jordan River Family
Medicine
Julien, Katie United
States
Utah -South
Jordan
316 Best Quality Research
Inc.
Ledo-Sanchez,
Gustavo
United
States
Florida
-Hialeah
317 J. Lewis Research -
FirstMed East
Plunkett,
Stephanie
United
States
Utah -Salt
Lake City
318 MediSphere Medical
Research Center, an AMR
affiliate
Reyes, Hubert United
States
Indiana
-Evansville
319 Burke Primary Care Smith, Stephen United
States
North Carolina
-Morganton
320 Village Health Partners Ampajwala,
Madhavi
United
States
Texas -Plano
321 The Nebraska Medical
Center
Berg, Isaac United
States
Nebraska
-Grand Island
322 South Broward Research,
LLC
Blaze, Kenneth United
States
Florida
-Pembroke
Pines
323 WR-Global Medical
Research, LLC
Ebuh,
Valentine
United
States
Texas -DeSoto
324 Lucita M. Cruz, MD, Inc Cruz, Lucita United
States
California
-Norwalk
325 Frontier Clinical
Research
Goisse, Marcy United
States
Pennsylvania
-Smithfield
326 Ark Clinical Research Kim, Kenneth United
States
California
-Long Beach
327 Advanced Research
Institute
Lowe, John United
States
Utah -Ogden
328 Research Center of
Fresno, Inc.V
Mariano,
Hipolito
United
States
California
-Fresno
329 SIMA Research Clinic Ortiz Munoz,
Luis
United
States
Florida -Miami
330 Craig A. Spiegel, MD Spiegel, Craig United
States
Missouri
-Bridgeton
331 Cahaba Research Inc. Vaughn,
Michael
United
States
Alabama
-Birmingham
332 BI Research Center Troyan, Barry United
States
Texas -Houston
333 Axcess Medical
Research, LLC
Shamaskin,
Susan
United
States
Florida
-Wellington
334 Progressive Medicine of
the Triad, LLC
Tarleton,
Gregory
United
States
North Carolina
-Winston-Sale
m
335 Coral Research Clinic
corp
Abreu, Edel United
States
Florida -Miami
336 William Beaumont
Hospital
Bastani, Aveh United
States
Michigan -Troy
337 South Florida Research
Center Inc.
Benitez, Omar United
States
Florida -Miami
338 Invocare Clinical
Research Center
Boone, Tasha United
States
South Carolina
-West Columbia
339 William Beaumont
Hospital
Clark, Carol United
States
Michigan
-Royal Oak
340 Montana Medical
Research
Cone, Clancy United
States
Montana
-Missoula
341 West Houston Clinical
Research Services
DeValle, Oscar United
States
Texas -Houston
342 Ericksen Research &
Development, LLC
Dixon, Tyler United
States
Utah -Clinton
343 Complete Family Care Doehring,
Larry
United
States
Colorado
-Northglenn
344 Clinical Research of Jarratt, United North Carolina
Gastonia Mikell States -Gastonia
345 Dairy Ashford Family
Practice
Jiang, Nan United
States
Texas
-Pearland
346 Adam D. Karns, MD Karns, Adam United
States
California
-Los Angeles
347 San Diego Sports
Medicine & Family
Health Center
Ralph, Lee United
States
California
-San Diego
348 New Horizon Research
Center, Inc
Nunez, Lazaro United
States
Florida -Miami
349 Snake River Research,
PLLC
Nathan,
Richard
United
States
Idaho -Idaho
Falls
350 Innovative Clinical
Research, Inc.
Osea, Edgardo United
States
California
-Harbor City
351 Allied Clinical
Research
Palatnik,
Mikhail
United
States
California
-Gold River
352 Grace Research, LLC Palmer, April United
States
Louisiana
-Shreveport
353 Crystal Biomedical
Research
Rico, Angel United
States
Florida -Miami
Lakes
354 Care Partners Clinical
Research, LLC
Barbel-Johnso
n, Kim
United
States
Florida
-Jacksonville
355 OnSite Clinical
Solutions, LLC
Bauer, Steven United
States
North Carolina
-Charlotte
356 Medical Associates
Research Group, Inc.
Bennett,
Michael
United
States
California
-San Diego
357 Wilmington Health Cannon, Kevin United
States
North Carolina
-Wilmington
358 DeGarmo Institute of
Medical Research
DeGarmo,
Ronald
United
States
South Carolina
-Greer
359 Clinical Neuroscience
Solutions, Inc.
Dever, Michael United
States
Florida
-Orlando
360 The Research Group of
Lexington, LLC
Farris, Neil United
States
Kentucky
-Lexington
361 Massachusetts General
Hospital
Filbin,
Michael
United
States
Massachusetts
-Boston
362 Arcturus Healthcare,
PLC
Fraser, Neil United
States
Michigan -Troy
363 Benchmark Research
Sacramento
Hachigian,
Greg
United
States
California
-Sacramento
364 MedPharmi Jeanfreau,
Robert
United
States
Louisiana
-Metairie
365 PMG Research of
Knoxville
Kirby, John United
States
Tennessee
-Jefferson
City
366 PMG Research of
Bristol, LLC
Martin,
Frederick
United
States
Tennessee
-Bristol
367 PMG Research of
Charleston, LLC
Mills, Richard United
States
South Carolina
-Mount
Pleasant
368 Downtown LA Research
Center, Inc
Nadkarni,
Salil
United
States
California
-Los Angeles
369 Millennium Clinical
Trials, LLC - Arlington
Natividad,
Maria Bella
United
States
Virginia
-Arlington
370 Wayne State University
School of Medicine
Paxton, James United
States
Michigan
-Detroit
371 J. Lewis Research, Inc.
Foothill Family Clinic
Peterson,
James
United
States
Utah -Salt
Lake City
372 Destin Pulmonary
Critical Care, PLLS.
Phillips,
David
United
States
Florida -Santa
Rosa Beach
373 Mercury Street Medical
Group
Pullman, John United
States
Montana -Butte
374 University of Texas
Medical Branch at
Galveston
Rupp, Richard United
States
Texas
-Galveston
375 Southwest Clinical
Trials
Shaikh,
Zeeshan
United
States
Texas -Houston
376 PMG Research of Cary,
LLC
Shoffner,
Sylvia
United
States
North Carolina
-Cary
377 Southeastern Research
Center LLC
Sigal, Barry United
States
North Carolina
-Winston-Sale
m
378 Chase Medical Research,
LLC
Soufer, Joseph United
States
Connecticut
-Hamden
379 Family Medicine
Associates of Texas,
P.A.
Stewart,
Jeffrey
United
States
Texas
-Carrollton
380 Tri-County Research,
Inc.
Stoller,
Stuart
United
States
Michigan
-Sterling
Heights
381 California Allergy &
Asthma Medical Group
Inc.
Tan, Ricardo United
States
California
-Los Angeles
382 Nuren Medical &
Research Center
Vaca, Carlos United
States
Florida -Miami
383 Wayne State University
School of Medicine
Wilburn, John United
States
Michigan
-Detroit
384 San Gabriel Clinical Willis, John United Texas
Research, LLC States -Georgetown
385 AAPRI Clinical Research
Institute
Zwetchkenbaum
, John
United
States
Rhode Island
-Warwick
386 Combined Research
Orlando
Ausaf, Niaz United
States
Florida
-Orlando
387 The Johns Hopkins
Hospital
Rothman,
Richard
United
States
Maryland
-Baltimore
388 Saltzer Medical Group Aguilar,
Richard
United
States
Idaho -Nampa
389 Barrett Clinic P.C. Ahlers, Kevin United
States
Nebraska -La
Vista
390 A+ Research Inc. Ebran-Gonzale
z, Raul
United
States
Florida -Miami
391 Preferred Primary Care
Physicians
Hartley, Paul United
States
Pennsylvania
-Uniontown
392 Miller Children's at
Long Beach Medical
Center
Deveikis,
Audra
United
States
California
-Long Beach
393 Monroe Biomedical
Research
Igbinadolor,
Awau
United
States
North Carolina
-Monroe
394 PCP for Life Karimjee,
Najmuddin
United
States
Texas -Houston
395 Stanford University
Hospital
Pearl, Ronald United
States
California
-Stanford
396 DM Clinical Research Reyes, Ramon United
States
Texas -San
Antonio
397 JM Research.PLLC Rodriguez,
Julio
United
States
Texas -Houston
398 Clinical Research of
Lancaster
Shealy, Keith United
States
South Carolina
-Lancaster
399 St. Michael's Medical
Center
Slim, Jihad United
States
New Jersey
-Newark
400 Om Research, LLC Allen, Richard United
States
California
-Lancaster
401 University of Maryland
Medical Center
Wilkerson,
Richard Gentry
United
States
Maryland
-Baltimore
402 Granger Medical Clinic
- Riverton
Devenport,
Stephen
United
States
Utah -Riverton
403 Lynn Institute of the
Rockies
Hollister,
Ripley
United
States
Colorado
-Colorado
Springs
404 Emerson Clinical
Research Institute, LLC
Geddes,
Caroline
United
States
District of
Columbia
-Washington
405 HP Clinical Research. Hansen, Val United
States
Utah
-Bountiful
406 Ann & Robert H. Lurie
Children's Hospital of
Chicago
Muller,
William
United
States
Illinois
-Chicago
407 Next Phase Research
Alliance
Aguiar, Oricel United
States
Florida -Miami
408 SC Clinical Research,
Inc.
Dao, Michael United
States
California
-Garden Grove
409 PMG Research of
Knoxville
Wakefield,
Paul
United
States
Tennessee
-Knoxville
410 Detweiler Family
Medicine & Associates
Kessler, Evan United
States
Pennsylvania
-Lansdale
411 Alabama Clinical
Therapeutics, LLC
Flippo,
Gregory
United
States
Alabama
-Birmingham
412 Omega Research
Consultants
Ayesu, Kwabena United
States
Florida
-Debary
413 PMG Research of Rocky
Mount, LLC
Browder,
Lesley
United
States
North Carolina
-Rocky Mount
414 Spectrum Medical
Research
Cutchin,
Richard
United
States
South Carolina
-Gaffney
415 Homestead Associates in
Research Inc
Seco, Gilberto United
States
Florida -Miami
416 ASCLEPES Research
Centers, P.C.
Gupta, Neeraj United
States
California
-Panorama City
417 Paradigm Clinical
Research Centers, Inc.
Elzi, Stanton United
States
Colorado
-Wheat Ridge
418 University of Texas
Southwestern Medical
Center
Jain, Mamta United
States
Texas -Dallas
419 Northwest Med Care,P.A. Naygandhi,
Yamini
United
States
Texas -Cypress
420 Universal Clinical
Research
Bermudez,
Lidia
United
States
Florida
-Hialeah
421 ClinPoint Trials Ledbetter,
Thomas
United
States
Texas
-Waxahachie
422 Vista Health Research,
LLC
Blanco,
Antonio
United
States
Florida -Miami
423 Renovatio Clinical Siddiqi, Ather United
States
Texas -The
Woodlands
424 Carolina Institute for
Clinical Research
Ferro, Richard United
States
North Carolina
-Fayetteville
425 Fusion Clinical
Research of Spartanburg
Koser, Andras United
States
South Carolina
-Spartanburg
426 Investigators Research
Group, LLC
Maynard,
Kenneth
United
States
Indiana
-Brownsburg
427 Tekton Research Adetona,
Olutola
United
States
Texas -San
Antonio
428 Premier Medical Khanna, Dinesh United
States
Florida -The
Villages
429 Asclepes Research
Centers
Benson, Dalton United
States
Florida -Weeki
Wachee
430 Albert Einstein
Healthcare Network
Raspberry,
Dara
United
States
Pennsylvania
-Philadelphia
431 SMS Clinical Research
LLC.
Saiger, Salma United
States
Texas
-Mesquite
432 Invocare Clinical
Research Center
White II,
Hubert
United
States
South Carolina
-West Columbia
433 Pines Care Research
Center, Inc.
Moya, Jaynier United
States
Florida
-Pembroke
Pines
434 Encore Medical
Research, LLC
Rondon, Juan United
States
Florida
-Hollywood
435 Floridian Clinical
Research
Sanchez,
William
United
States
Florida
-Hialeah
436 Dayton Clinical
Research
Schear, Martin United
States
Ohio -Dayton
437 West Coast Research Tan, Alfred United
States
California
-San Ramon
438 Hutchinson Clinic Ruhlmann,
James
United
States
Kansas
-Hutchinson
439 University of Alabama
at Birmingham - (UAB)
Poole,
Claudette
United
States
Alabama
-Birmingham
440 Cozy Research Yousef,
Jonathan
United
States
Florida
-Zephyrhills
441 University of Oklahoma
Health Sciences Center
Metcalf,
Jordan
United
States
Oklahoma
-Oklahoma City
442 Bach Mai Hospital Do, Cuong Vietnam NA -Hanoi
443 National Hospital for
Tropical Diseases
Nguyen, Kinh Vietnam NA -Hanoi
444 Nguyen Tri Phuong
Hospital
Cao, Nhan Vietnam NA -Ho Chi Minh
445 Hospital of Lithuanian
University of Health
Sciences Kaunas Clinics
Valius, Leonas Lithuani
a
NA -Kaunas
五、伦理委员会信息
序号 名称 审查结论 批准日期/审查日期
1 中日友好医院临床研究伦理委员
会
同意 2019-06-19
2 中日友好医院临床研究伦理委员
会
同意 2019-08-02
六、试验状态
1、试验状态
主动终止（对于 63623872FLZ3002研究的期中分析，我们在 2020 年 2 月 28日前
招募并纳入了 513例随机化受试者。IDMC遵循分析计划，评价症状发作后 72小
时内随机化患者的治疗效果。此外，根据观察到的治疗效果进行了样本量重估。
最后，基于新的样本量，对主要终点进行无效性评估。 IDMC告知 Janssen，在
有流感并发症风险的患者中比较 Pimodivir和安慰剂治疗时未观察到无效性，建
议继续 63623872FLZ3002研究并进行调整。 经过充分考虑，考虑到在
63623872FLZ3001研究（Pimodivir的并行 III期研究）中观察到的无效性，
Janssen做出了停止 63623872FLZ3002研究的战略决策。）
2、试验人数
目标入组人数 国内: 108 人；国际: 720 人；
已入组人数 国内: 0 人；国际: 553 人；
实际入组总人数 国内: 0 人；国际: 553 人；
3、受试者招募及试验完成日期
第一例受试者签署知情同意书
日期
国内：登记人暂未填写该信息；国际：
2018-01-24
第一例受试者入组日期 国内：登记人暂未填写该信息；国际：
2018-01-24
国内：2020-08-28；国际：2020-08-28
七、临床试验结果摘要
序号 版本号 版本日期