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-G000-310 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
首都医科大学附属北京佑安医院	丁惠国

序号	机构名称	主要研究者	国家	省（州）	城市
1	首都医科大学附属北京佑安医院	丁惠国	中国	NA	北京
2	上海交通大学医学院附属瑞金医院	谢青	中国	NA	上海
3	中南大学湘雅医院	黄燕	中国	湖南	长沙
4	University of Southern California Medical Center	Sher Linda	US	CA	Los Angeles
5	University of California San Francisco - Medical Center	Terrault Norah	US	CA	San Francisco
6	California Pacific Medical Center Research Institute	Bonacini Maurizio	US	CA	San Francisco
7	Inland Empire Liver Foundation	Kayali Zeid	US	CA	San Bernardino
8	Ochsner Clinic Foundation	Joshi Shobha	US	LA	New Orleans
9	Drexel University College of Medicine	Rothstein Kenneth	US	PA	Philadelphia
10	Mayo Clinic - Rochester	Sanchez William	US	MN	Rochester
11	Weill Cornell Medical College-New York Presbyterian Hospital	Kumar Sonal	US	NY	New York
12	Mount Sinai Medical Center	Chang Charissa	US	NY	New York
13	University of Texas Health Science Center at San Antonio	Guerrero Juan	US	TX	San Antonio
14	The University of Minnesota	Lake John	US	MN	Minneapolis
15	University of California Davis Health System Division of Gastroenterology	Bowlus Christopher	US	CA	Sacramento
16	Baylor Research Institute / Baylor Endocine Center	Modi Apurva	US	TX	Dallas
17	New York University Medical Center	Teperman Lewis	US	NY	New York
18	Montefiore Medical Center	Reinus John	US	NY	Bronx
19	Baylor St. Luke's Episcopal Hospital	Vierling John	US	TX	Houston
20	Ronald Reagan UCLA Medical Center	Zarrinpar Ali	US	CA	Los Angeles
21	Tampa General Hospital	Alsina Angel	US	FL	Tampa
22	Mayo Clinic in Florida	Satyanarayana Raj	US	FL	Jacksonville
23	VA Long Beach Health Care System	Morgan Timothy	US	CA	Long Beach
24	Hospital Británico de Buenos Aires	Colombato Luis	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
25	Fundacion Favaloro	Descalzi Valeria	Argentina	Ciudad Autonoma Buenos Aires	Ciudad Autonoma Buenos Aires
26	Hospital Universitario Austral	Silva Marcelo Oscar	Argentina	Buenos Aires	Pilar
27	Hospital Luis Lagomaggiore	Milutin Carlos Alberto	Argentina	Mendoza	Mendoza
28	Funda？？o Faculdade Regional de Medicina de S？o José do Rio Preto	Martins Alves da Silva Rita de Cássia	Brazil	Sao Paulo	Sao José do Rio Preto
29	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Marroni Cláudio Augusto	Brazil	Rio Grande do Sul	Porto Alegre
30	UNIFESP - Universidade Federal de S？o Paulo	de Carvalho Filho Roberto José	Brazil	Sao Paulo	Sao Paulo
31	Hospital das Clínicas da Faculdade de Medicina da USP	Queiroz Farias Alberto	Brazil	Sao Paulo	Sao Paulo
32	Hospital de Clínicas de Porto Alegre	Reis álvares-da-Silva Mário	Brazil	Rio Grande do Sul	Porto Alegre
33	Toronto Liver Centre	Elkhashab Magdy	Canada	Ontario	Toronto
34	LHSC - University Hospital	Marotta Paul	Canada	Ontario	London
35	Toronto Western Hospital Liver Clinic	Feld Jordan	Canada	Ontario	Toronto
36	Hospital Barros Luco Trudeau	Marquez Sylvia	Chile	NA	Santiago
37	Hospital Padre Alberto Hurtado	Contreras Jorge	Chile	NA	Santiago
38	Hospital Militar de Santiago	Garcia Neira Julio Cesar	Chile	NA	Santiago
39	The Catholic University of Korea Seoul St. Mary’s Hospital	Choi Jong Young	Korea	NA	Seoul
40	Seoul National University Hospital	Yoon Jung-Hwan	Korea	NA	Seoul
41	Pusan National University Hospital	Heo Jeong	Korea	NA	Busan
42	Gangnam Severance Hospital, Yonsei University Health System	Lee Kwan Sik	Korea	NA	Seoul
43	Asan Medical Center	Lim Young-Suk	Korea	NA	Seoul
44	CHA Bundang Medical Center, CHA University	Hwang Seong Gyu	Korea	Gyeonggi-do	Seongnam-Si
45	Severance Hospital, Yonsei University Health System	Kim Do-Young	Korea	NA	Seoul
46	Kyungpook National University Hospital	Tak Won Young	Korea	NA	Daegu
47	Ajou University Hospital	Cho Sung-Won	Korea	Gyeonggi-do	Suwon
48	Pusan National University Yangsan Hospital	Yoon Ki Tae	Korea	Gyeongnam	Yangsan-si
49	Samsung Medical Center	Paik Seung Woon	Korea	NA	Seoul
50	Dong-A University Hospital	Lee SungWook	Korea	NA	Busan
51	Hallym University Chuncheon Sacred Heart Hospital	Kim DongJoon	Korea	Gangwon-do	Chuncheon-si
52	Cathay General Hospital	Yang Sien-Sing	中国	NA	Taipei city
53	Taipei Veterans General Hospital	Hou Ming-Chih	中国	NA	Taipei
54	Kaohsiung Medical University Chung-Ho Memorial Hospital	Chuang Wan-Long	中国	NA	Kaohsiung
55	National Cheng Kung University Hospital	Chang Ting-Tsung	中国	NA	Tainan city
56	Thammasat University Hospital	Vilaichone Ratha-Korn	Thailand	Pathumthani	Klong Luang
57	Siriraj Hospital	Tanwandee Tawesak	Thailand	Bangkok	Bangkoknoi
58	Maharaj Nakorn Chiang Mai Hospital	Thongsawat Satawat	Thailand	Chiang Mai	Muang
59	Ramathibodi Hospital	Sobhonslidsuk Abhasnee	Thailand	Bangkok	Ratchathewi
60	Royal Prince Alfred Hospital	Strasser Simone	Australia	New South Wales	Camperdown
61	Flinders Medical Centre	Wigg Alan	Australia	South Australia	Bedford Park
62	Royal Adelaide Hospital	McRae Simon	Australia	South Australia	Adelaide
63	Wilhelminenspital der Stadt Wien	Gschwantler Michael	Austria	NA	Wien
64	Krankenhaus der Elisabethinen Linz GmbH	Maieron Andreas	Austria	NA	Linz
65	AKH - Medizinische Universit？t Wien (Universit？tsklinik für Chirurgie)	Mühlbacher Ferdinand	Austria	NA	Vienna
66	Bekes Megyei Pandy Kalman Korhaz III. Belgyogyaszat	Fazekas Ilona	Hungary	NA	Gyula
67	Semmelweis Egyetem AOK	Mathe Zoltan	Hungary	NA	Budapest
68	Bekes Megyei Pandy Kalman Korhaz. Infektologia es Hepatologia	Banyai Tivadar	Hungary	NA	Gyula
69	Szent Pantaleon Korhaz -Rendelointezet Dunaujvaros	Varga-Szabo Lajos	Hungary	NA	Dunaujvaros
70	Somogy Megyei Kaposi Mor Oktato Korhaz	Hunyady Bela	Hungary	NA	Kaposvar
71	Semmelweis Egyetem AOK (I.Belklinika, Hepatológiai Ambulancia)	Szalay Ferenc	Hungary	NA	Budapest
72	Zala Megyei Korhaz (Belgyógyászati Osztály)	Gasztonyi Beata	Hungary	NA	Zalaegerszeg
73	Dr Rethy Pal Korhaz-Rendelointezet (III. Belgyogyaszat-Gasztroenterologia-Hepatologia)	Varga Marta	Hungary	NA	Bekescsaba
74	Markusovszky Egyetemi Oktatokorhaz (Belgyogyaszat,Gasztroenterologia)	Schneider Ferenc	Hungary	NA	Szombathely
75	Bacs-Kiskun Megyei Korhaz (Gastroenterologiai-Belgyogyaszati O.)	Szepes Attila	Hungary	NA	Kecskemet
76	ULB Hospital Erasme (300133885)	Moreno Christophe	Belgium	NA	Bruxelles
77	C.H.U. Brugmann - Site Victor Horta (150002289)	Lasser Luc	Belgium	NA	Bruxelles
78	UZ Leuven (300134784)	Nevens Frederik	Belgium	NA	Leuven
79	CHU ESTAING, Clermont-Ferrand ( Service de Médecine Digestive et Hépatobiliaire)	Abergel Armando	France	Puy de Dome	Clermont Ferrand cedex 1
80	CHU de Grenoble - Hopital Nord (Hépato-Gastroentérologie)	Leroy Vincent	France	Isere	Grenoble cedex 9
81	Hopital Robert Debre (Hépato-Gastro-Entérologie & Cancérologie Digestive)	Heurgue Berlot Alexandra	France	Marne	Reims
82	CHU Amiens - Hopital Nord (service d'hepatogastroenterologie)	Nguyen-Khac Eric	France	Somme	Amiens cedex 1
83	Nouvel Hopital Civil - CHU Strasbourg (Service d'Hépato-Gastro-Entérologie - Clinique médicale B)	Habersetzer Francois	France	Bas Rhin	Strasbourg
84	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Andreone Pietro	Italy	Bologna	Bologna
85	IRCCS Ospedale Casa Sollievo della Sofferenza	Iacobellis Angelo	Italy	Foggia	San Giovanni Rotondo
86	Azienda Ospedaliera Fatebenefratelli e Oftalmico (SC di Medicina Interna ad indirizzo epatologico)	Bruno Savino	Italy	Milano	Milano
87	Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari (Gastroenterologia Universitaria)	Di Leo Alfredo	Italy	Bari	Bari
88	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia (300206562)	Toniutto Pierluigi	Italy	Udine	Udine
89	Azienda Ospedaliero Universitaria San Martino (Dipartimento di Medicina Int. e Specialità Mediche)	Savarino Vincenzo	Italy	Genova	Genova
90	ISMETT-Istituto Mediterraneo per i Trapianti e le Terapie ad alta specializzazione	Vizzini Giovanni	Italy	Palermo	Palermo
91	A.O.U. Policlinico di Modena (U.O Gastroenterologia)	Villa Erica	Italy	Modena	Modena
92	Institut fuer interdisziplinaere Infektiologie & Immunologie	Buggisch Peter	Germany	Hamburg	Hamburg
93	Ev. Krankenhausgemeinschaft Herne	Leodolter Andreas	Germany	Nordrhein Westfalen	Herne
94	Universitaetsklinikum Koeln (Gastroenterologie und Hepatologie)	Goeser Tobias	Germany	Nordrhein Westfalen	Koeln
95	Universitaetsklinikum Freiburg (Innere Medizin II - Gastroenterologie, Hepatologie)	Bausch Birke	Germany	Baden Wuerttemberg	Freiburg
96	Gastroenterologisch - Hepatologisches Zentrum Kiel (Standort Kiel Elmschenhagen)	Hinrichsen Holger	Germany	Schleswig Holstein	Kiel
97	Wojew. Szpital Specj. im. J. Gromkowskiego (Dept of Infectious Diseases, Liver Diseases)	Simon Krzysztof	Poland	NA	Wroclaw
98	Wojewódzki Specjalistyczny Szpital im. Wl. Bieganskiego	Jablkowski Maciej	Poland	NA	Lodz
99	SP CSK im. prof. K. Gibinskiego SUM (150313274)	Hartleb Marek	Poland	NA	Katowice
100	ID Clinic	Janczewska Ewa	Poland	NA	Myslowice
101	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Baldaia Cilenia	Portugal	NA	Lisboa
102	Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE Hosp S.Pedro	Ramos Jose	Portugal	NA	Vila Real
103	Centro Hospitalar e Universitário de Coimbra E.P.E	Carvalho Armando	Portugal	NA	Coimbra
104	Centro Hospitalar Tondela-Viseu, EPE - Hospital Sao Teotónio	Costa Luís	Portugal	NA	Viseu
105	Unidade Local de Saude do Alto Minho, EPE Hospital Sta Luzia	Andrade Joao	Portugal	NA	Viana do Castelo
106	Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António (Neurology Department)	Helena Miranda	Portugal	NA	Porto
107	Hospital Universitari i Politecnic La Fe (Servicio de Medicina Digestiva)	Prieto Castillo Martin	Spain	Valencia	Valencia
108	Hospital Universitario Nuestra Se？ora de Valme (Servicio de Neurologia)	Romero-Gomez Manuel	Spain	Sevilla	Sevilla
109	Hospital Montecelo (150909704)	Turnes Vazquez Juan	Spain	Pontevedra	Pontevedra
110	Hospital Universitario del Rio Hortega (150516055)	Sanchez Antolin Gloria	Spain	Valladolid	Valladolid
111	Hospital Clinic i Provincial de Barcelona (150314858)	Gines Gibert Pere	Spain	Barcelona	Barcelona
112	New Cross Hospital (Dept Of Oncology/Haematology)	Brookes Matthew	United Kingdom	West Midlands	Wolverhampton
113	Royal Free Hospital (Sheila Sherlock Liver Centre)	Patch David	United Kingdom	Greater London	London
114	King's College Hospital (Institute of Liver Studies)	Agarwal Kosh	United Kingdom	Greater London	London
115	St James's University Hospital (PARENT)	Aldersley Mark	United Kingdom	West Yorkshire	Leeds
116	南京市第二医院	杨永峰	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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