治疗进行择期手术的慢性肝病患者的血小板减少症

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一、临床试验项目名称
治疗进行择期手术的慢性肝病患者的血小板减少症

二、适应症
肝病相关的血小板减少症

三、试验介绍

E5501-G000-311是择期手术前肝病相关性血小板减少症成人患者每日口服一次avatrombopag的有效性和安全性：一项全球性、随机、双盲、安慰剂对照、平行分组研究

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
北京大学第一医院	王贵强

序号	机构名称	主要研究者	国家	省（州）	城市
1	北京大学第一医院	王贵强	中国	NA	北京
2	四川大学华西医院	冯萍	中国	四川	成都
3	浙江大学附属第一医院	李兰娟	中国	浙江	杭州
4	Instituto Centralizado de Asistencia e Investigaci	Bessone Fernando	Argentina	Santa Fe	Rosario
5	Hospital Privado Centro Medico de Cordoba	Conte Damian Vicente	Argentina	Cordoba	Cordoba
6	Hospital Italiano de Buenos Aires	Gadano Adrian	Argentina	Buenos Aires	Ciudad Autonoma Buenos Aires
7	Hospital Provincial del Centenario	Tanno Hugo	Argentina	Santa Fe	Rosario
8	Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo	Cartier Mariano	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
9	CER Instituto Medico	Gimenez Edgardo	Argentina	Buenos Aires	Quilmes
10	Hospital Británico de Buenos Aires	Colombato Luis	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
11	Fundacion Favaloro	Descalzi Valeria	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
12	Hospital Universitario Austral	Silva Marcelo Oscar	Argentina	Buenos Aires	Pilar
13	Hospital Luis Lagomaggiore	Milutin Carlos Alberto	Argentina	Mendoza	Mendoza
14	UPECLIN – Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP	Gomes Romeiro Fernando	Brazil	Sao Paulo	Botucatu
15	Hospital Ernesto Dornelles	Becker Sander Guilherme	Brazil	Rio Grande do Sul	Porto Alegre
16	Hospital Beneficência Portuguesa de Sao Paulo	de Escobar Ferraz Neto José Ben Hur	Brazil	Sao Paulo	Sao Paulo
17	HUPES-UFBA - Hospital Universitário Professor Edgard Santos - Universidade Federal da Bahia	Paraná Raymundo	Brazil	Bahia	Salvador
18	HU-UFS - Hospital Universitário - Universidade Federal de Sergipe	Vianey Callado Franca Alex	Brazil	Sergipe	Aracaju
19	Zeidler Ledcor Centre - University of Alberta	Tandon Puneeta	Canada	Alberta	Edmonton
20	University of Calgary	Lee Samuel	Canada	Alberta	Calgary
21	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Lazcano Soto Jose	Mexico	Durango	Durango
22	Centro de Investigacion y Transferencia en Salud, Fundacion Santos y de la Garza Evia, IBP	Marrufo Garcia Cesar	Mexico	Nuevo León	Monterrey
23	Global Trial Research Center S.A. de C.V.	Riojas Charles Ciro Manuel	Mexico	Nuevo León	Monterrey
24	Centro de Investigación Clínica Pensiones	Solis Gasca Luis	Mexico	Yucatán	Merida
25	Hospital Universitario José Eleuterio González Servicio de Gastroenterología	Cortez Hernandez Carlos	Mexico	Nuevo León	Monterrey
26	Saluz Investigacion SC	Meixueiro Daza Arturo	Mexico	Veracruz	Boca del Rio
27	Clinical Medical Research, S.C.	Gomez Rangel Jose	Mexico	Veracruz	Orizaba
28	Investigacion Biomedica para el Desarrollo de Farmacos SA de CV	Gonzalez Moresco Ricardo	Mexico	Jalisco	El Salto
29	Medical Professionals Dedicated to Clinical Research SC	Flores Lorenzo Candido	Mexico	Distrito Federal	Mexico City
30	Ultimate Medica SA de CV	Frenk Baron Paul	Mexico	Distrito Federal	Mexico City
31	Austin Hospital (PARENT)	Gow Paul	Australia	Victoria	Melbourne
32	The Alfred Hospital (PARENT)	Roberts Stuart	Australia	Victoria	Melbourne
33	Monash Medical Centre-Clayton Campus (300183892)	Chunilal Sanjeev	Australia	Victoria	Clayton
34	Royal Melbourne Hospital (PARENT)	Sood Siddharth	Australia	Victoria	Parkville
35	Western Hospital (PARENT)	Kronborg Ian	Australia	Victoria	Footscray
36	Southern California Research Center	Hassanein Tarek	US	CA	Coronado
37	Tulane Medical Center	Moehlen Martin	US	LA	New Orleans
38	University of Texas Health Science Center at Houston	Fallon Michael	US	TX	Houston
39	University of Washington Medical Center	Landis Charles	US	WA	Seattle
40	Henry Ford Health Center	Segovia Maria	US	MI	Detroit
41	Mayo Clinic Arizona	Vargas Hugo	US	AZ	Phoenix
42	Tufts Medical Center	Lee Hannah	US	MA	Boston
43	Beth Israel Deaconess Medical Center - Dept of Neurology	Afdhal Nezam	US	MA	Boston
44	University of Colorado	Everson Gregory	US	CO	Denver
45	University of Maryland at Baltimore, School of Medicine	Hutson William	US	MD	Baltimore
46	Saint Luke's Hospital of Kansas City	Cho Kenneth	US	MO	Kansas City
47	Medical University of South Carolina	Chavin Kenneth	US	SC	Charleston
48	Baylor Research Institute / Baylor Endocrine Center	Trotter James	US	TX	Dallas
49	Columbia University	Brown Robert	US	NY	New York
50	Johns Hopkins Bayview Medical Center	Dadabhai Alia	US	MD	Baltimore
51	Texas Liver Institute/American Research Corporation	Poordad Fred	US	TX	San Antonio
52	Universtiy of Kansas Medical Center	Gilroy Richard	US	KS	Kansas City
53	Yale University	Liapakis AnnMarie	US	CT	New Haven
54	University of Miami, Miller School of Medicine	Martin Paul	US	FL	Miami
55	UZ Antwerpen	Francque Sven	Belgium	NA	Edegem
56	C. H. U. Sart Tilman	Delwaide Jean	Belgium	NA	Liege
57	Universitair Ziekenhuis Gent (300109957)	Van Vlierberghe Hans	Belgium	NA	Gent
58	Fakultni nemocnice Ostrava	Gumulec Jaromir	Czech Republic	NA	Ostrava
59	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z	Tichy Michal	Czech Republic	NA	Usti nad Labem
60	Institut klinicke a experimentalni mediciny	Drastich Pavel	Czech Republic	NA	Praha 4
61	Fakultni nemocnice Brno	Mayer Jiri	Czech Republic	NA	Brno
62	CHU Rennes - Hopital Pontchaillou (unite d'investigation clinique --Pavillon Clemenceau)	Laine Fabrice	France	Ille et Vilaine	Rennes cedex 09
63	Hopital Paul Brousse (Service Gastro-Enterologie et Hepatologie Bilaire)	Samuel Didier	France	Val de Marne	Villejuif
64	CHU Nice - Hopital de l'Archet 2 (Service de Gastro-Enterologie et Nutrition)	Tran Albert	France	Alpes Maritimes	Nice Cedex 3
65	Hopital Beaujon (Hepato Gastro Enterologie)	Rautou Pierre-Emmanuel	France	Hauts de Seine	Clichy cedex
66	Centre Hospitalier de la Croix Rousse (Service d'Hépato-Gastro-Entérologie)	Zoulim Fabien	France	Rhone	Lyon Cedex 04
67	Fondazione IRCCS CA’ Granda Ospedale Maggiore Policlinico (U.O. di Gastroenterologia 1)	Colombo Massimo	Italy	Milano	Milano
68	Policlinico Universitario Agostino Gemelli (UOC Clinica Medica)	Grieco Antonio	Italy	Roma	Roma
69	Azienda Ospedaliero Universitaria Pisana (Chirurgia Epatica e del Trapianto Fegato)	De Simone Paolo	Italy	Pisa	Pisa
70	Azienda Ospedaliera Universitaria Policlinico Tor Vergata ( Dipartimento di Medicina Epatologia)	Angelico Mario	Italy	Roma	Roma
71	Azienda Ospedaliera Universitaria Policlinico Tor Vergata ( UOC Chirurgia dei Trapianti)	Tisone Giuseppe	Italy	Roma	Roma
72	Azienda Ospedaliera Universitaria Careggi ( Malattie Infettive)	Laffi Giacomo	Italy	Firenze	Firenze
73	Azienda Provinciale per i Servizi Sanitari	Brolese Alberto	Italy	Trento	Trento
74	Umberto I Pol. di Roma-Università di Roma La Sapienza (Dip Di Medicina Interna e Specialità Mediche)	Violi Francesco	Italy	Roma	Roma
75	Ospedale Ramazzini di Carpi (Gastroenterologia - Poliambulatori)	Conigliaro Rita	Italy	Modena	Carpi
76	Rambam Health Care Campus (300166190)	Baruch Yaacov	Israel	NA	Haifa
77	The Lady Davis Carmel Medical Center (150310215)	Zuckerman Eli	Israel	NA	Haifa
78	Chaim Sheba Medical Center	Ben Ari Ziv	Israel	NA	Ramat-Gan
79	Ziv Medical Center (300174012)	Assy Nimer	Israel	NA	Safed
80	Hadassah University Hospital - Ein Kerem (300112789)	Safadi Rifaat	Israel	NA	Jerusalem
81	Rabin Medical Center-Beilinson Campus (300151550)	Braun Marius	Israel	NA	Petach Tikva
82	Tel Aviv Sourasky MC, Dana childrens hospital (300109912)	Bruck Rafael	Israel	NA	Tel Aviv
83	Assaf Harofeh Medical Center (150516499)	Broide Efrat	Israel	NA	Beer Yaakov
84	Kaplan Medical Center (150909891)	Maor Yaakov	Israel	NA	Rechovot
85	Wolfson Medical Center (300107996)	Avni Yona	Israel	NA	Holon
86	Medizinische Hochschule Hannover (Gastroenterologie, Hepatologie und Endokrinologie)	Wedemeyer Heiner	Germany	Niedersachsen	Hannover
87	Universitaetsklinikum Leipzig AoeR (Klinik u. Poliklinik f. Gastroenterologie Rheumat.)	Berg Thomas	Germany	Sachsen	Leipzig
88	Klinikum der Johann Wolfgang Goethe-Universitaet (Gastroenterologie und Hepatologie)	Zeuzem Stefan	Germany	Hessen	Frankfurt
89	Universitaetsklinikum Bonn AoeR (Medizinische Klinik I Gastroenterologie)	Spengler Ulrich	Germany	Nordrhein Westfalen	Bonn
90	Universitaetsklinikum Hamburg-Eppendorf (I. Medizinische Klinik - Gastroenterologie)	Lueth Stefan	Germany	Hamburg	Hamburg
91	Spitalul Clinic Judetean de Urgenta Sibiu (Sectia Cl. Med. I “Conf. Dr. Radu Ciuchendea	Porr Paul Jurgen	Romania	NA	Sibiu
92	Spitalul Universitar de Urgenta Militar Central	Ionita-Radu Florentina	Romania	NA	Bucuresti
93	Pierrel Research HP-RO SRL	Andor Minodora	Romania	NA	Timisoara
94	Spitalul Universitar de Urgenta Bucuresti (Sectia Medicina Interna - Gastroenterologie)	Fierbinteanu-Braticevici Carmen	Romania	NA	Bucuresti
95	Spitalul Clinic Judetean de Urgenta Craiova (Sectia Medicina Interna II)	Mitrut Paul	Romania	NA	Craiova
96	Spitalul Clinic Judetean de Urgenta Arad (Sectia Gastroenterologie)	Miutescu Eftimie	Romania	NA	Arad
97	Institutul de Gastroenterologie si Hepatologie Iasi (300110561)	Cijevschi Prelipcean Cristina	Romania	NA	Iasi
98	RU People’s Friendship on b.o.Liver Research Centre of Peoples’ Friendship University of Russia	Ogurtsov Pavel	Russian Federation	NA	Moscow
99	First Moscow State Medical University ,	Ivashkin Vladimir	Russian Federation	NA	Moscow
100	Medical Company	Morozov Vyacheslav	Russian Federation	NA	Samara
101	Clinical Hospital of Tsentrosoyuz LLC	Bogomolov Pavel	Russian Federation	NA	Moscow
102	Hospital General Universitario Gregorio Maranon (Infectious Diseases)	Rincon Diego	Spain	NA	Madrid
103	Hospital San Pedro de Alcantara (150516085)	Fernandez Bermejo	Spain	NA	Caceres
104	Hospital General Universitario de Valencia (Servicio de Patologia Digestiva)	Gonzalez Munoz Carmen	Spain	NA	Valencia
105	Hospital Universitario de La Princesa (300210872)	Garcia Buey Luisa Consuelo	Spain	NA	Madrid
106	Hospital Universitari Vall d'Hebron (Dept of Hepatology)	Gonzalez Fernandez Antonio	Spain	NA	Barcelona
107	中国人民解放军第八一医院	汪茂荣	中国	江苏	南京

1	筛选时受试者年龄≥18岁，并且患有慢性肝病
2	基线平均血小板计数＜50 × 10^9/L。在筛选期和基线时必须进行2次血小板计数检测，2次检测必须至少间隔1天，并且任何一次血小板计数测量值都不得＞60 × 10^9/L。2次血小板计数的平均值（基线平均血小板计数）将作为入组标准，以及将患者分配进入基线血小板计数较低或较高队列的标准。
3	受试者计划接受允许的择期操作，且除非血小板计数与基线相比发生有临床意义的变化，否则需要输注血小板
4	筛选时终末期肝病（MELD）模型评分≤24
5	如果使用P糖蛋白（P-gp）抑制剂，维拉帕米除外，治疗剂量必须在筛选前稳定7天
6	提供签字的知情同意书
7	愿意并能够遵守研究方案的所有要求

1	有任何动脉或静脉血栓形成史，包括不完全性或完全性血栓形成
2	在筛选时，门静脉主干、门静脉分支或脾脏肠系膜静脉系统任何部分有血栓形成（不完全性或完全性）证据
3	在筛选时，门静脉血流流速＜10 cm/秒
4	不能有效治疗的肝性脑病
5	受试者患有肝细胞癌，并且按照巴塞罗那临床肝癌分期标准（BCLC），癌症为C期或D期
6	在筛选前7天内输注血小板或使用含血小板的血液制品。不过，允许输注浓缩红细胞。
7	在筛选前7天内使用肝素、华法林、非甾体类抗炎药（NSAID）、阿司匹林、维拉帕米，以及噻氯匹定或糖蛋白IIb/IIIa 拮抗剂（如替罗非班）抗血小板治疗
8	在筛选前7天内使用红细胞生成刺激剂
9	在筛选前14天内使用干扰素（IFN）
10	在筛选前30天内使用含雌激素的激素避孕药或激素替代疗法
11	在筛选前7天内发生需要全身性抗生素治疗的活动性感染。不过，允许采用抗生素预防治疗。
12	在研究开始前6个月内有酒精滥用、酒精依赖综合征、药物滥用或药物依赖（除非正在参加控制康复项目），或在研究开始前6个月内发生急性酒精性肝炎（慢性酒精性肝炎允许）
13	在第4次访视（手术日）前进行择期手术
14	已知人免疫缺陷病毒阳性。
15	任何具有临床意义的急性或活动性出血（如，胃肠道、中枢神经系统等）
16	已知有任何原发性血液学疾病史（如，免疫性血小板减少性紫癜、骨髓增生异常综合征等）
17	已知有遗传性血栓前综合征病史（例如：凝血因子V Leiden突变；凝血酶原G20210A突变；ATIII缺乏等）
18	受试者有显著的心血管病史（如，纽约心脏协会分级为III/IV级的充血性心力衰竭、已知会增加血栓栓塞事件风险的心律失常[如，心房纤颤]、冠状动脉支架植入、血管成形术，和冠状动脉旁路移植术）
19	对于育龄女性，在进入研究前30天内有过未采取避孕措施的性行为，并且不同意在整个研究期间和停止研究药物治疗后30天内采取高效避孕措施（如，完全禁欲、宫内避孕器、双屏障法[如避孕套加含杀精剂的避孕膜]、仅含黄体酮的植入/注射避孕药，或配偶输精管切除并确认无精）。如果受试者正在禁欲，则必须同意如果在研究期间或停止研究药物治疗后30天内恢复性生活，愿意按上文所述采取双屏障避孕法。所有女性都应视为育龄女性，除非是绝经后女性（在适当的年龄组，至少连续12个月无月经，并且没有其他已知或可疑原因）或在给药前至少1个月接受了绝育手术（即，双侧输卵管结扎、子宫切除或双侧卵巢切除）
20	在筛选或基线时正处于哺乳期或妊娠期的女性（根据血清β-人绒毛膜促性腺激素[β hCG]检查进行确认，检查结果为阳性，且β hCG最低检测灵敏度为25 IU/L或等量单位）。如果在研究药物首次给药前超过72小时进行的筛选妊娠检查为阴性，则必须单独进行基线评价。
21	肝移植后受试者
22	之前接受过avatrombopag的任何受试者
23	对avatrombopag maleate或其任何辅料过敏
24	在筛选时，血红蛋白水平≤8.0或≥17.0 g/dL
25	当前患有恶性肿瘤，包括实体瘤和血液学恶性肿瘤（肝细胞癌除外）
26	根据研究者的判断，存在任何可能会影响受试者顺利完成研究的能力的医学病史或伴随医学状况
27	目前入组另一项临床试验或在筛选前30天内使用任何试验用药品或器械

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