登记号
CTR20132867
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
心房颤动
试验通俗题目
利伐沙班预防计划行心脏复律非瓣膜性心房纤颤患者研究
试验专业题目
比较利伐沙班与VKA在计划行心脏复律的非瓣膜性房颤患者中预防心血管事件的有效性和安全性的一项研究
试验方案编号
15693
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
临床试验信息公布组
联系人座机
010 65360866
联系人手机号
联系人Email
clinical-trials-contact@bayer.com
联系人邮政地址
北京市朝阳区东三环北路27号嘉铭中心B座18层
联系人邮编
100020
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
伴有异常心脏节律（心房纤颤）的患者计划进行心脏复律（使恢复正常心脏节律的操作）。此研究会比较患者随机（像投硬币一样）分配到利伐沙班组或维生素K拮抗剂（VKA）组。此研究会测量普通医学事件结果如出血或卒中。
随机化
随机化
盲法
开放
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
无岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 年龄≥18岁的男性或女性
- 血流动力学稳定的非瓣膜性房颤持续超过48小时或持续时间未知
- 计划进行非瓣膜性房颤的心脏复律（电复律或药物复律）
- 有生育可能的女性和男性必须同意在性行为时使用充分的避孕措施
排除标准
- 在随机化访视前3个月内有重度、致残性卒中（改良Rankin评分4–5分，含4和5分）或随机化访视前14天内有任何卒中
- 在随机化前3天内有短暂性缺血发作
- 在随机化前14天内有急性血栓栓塞事件或血栓（静脉/动脉）形成
- 在随机化前14天内有急性心肌梗死
- 心脏相关标准: 已知存在源性血栓或粘液瘤或瓣膜性房颤
- 抗凝剂治疗禁忌：活跃出血或高出血风险
- 合并用药：除房颤之外其他适用于抗凝治疗的疾病、长期阿司匹林治疗>100mg/天或双重抗血小板治疗、全身使用细胞色素P450（CYP）-3A4和P–糖蛋白（P-gp）的强抑制剂
- 伴发情况：有生育可能但未采用正确的避孕措施、妊娠或哺乳、对研究药物治疗或对照药物治疗过敏、计算得出肌酐清除率(CrCl)< 30mL/min？肝脏疾病伴随凝血病，导致有临床意义的出血风险？预期生命不足6个月的重度疾病？计划进行介入性操作有可能造成无法控制的出血，包括不能口服药物？目前存在药物成瘾或酗酒
- 对照药物治疗或试验药物治疗的当地说明书中所列的任何其他禁忌症
- 在随机化前30天内参加过研究性药物或医疗器械的研究
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:利伐沙班 (拜瑞妥, BAY59-7939)
|
用法用量:剂型：片剂
规格：15mg/20mg
给药途径：口服
用药频次：1次/天
剂量：15mg/20mg
用药时程：对于采用直接复律策略的患者，应在随机化后1–5天内进行心脏复律。利伐沙班或VKA在计划直接复律前给药1–5天，复律后给药42天。
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:维生素K拮抗剂 (VKA)
|
用法用量:剂型：片剂
规格：医生根据当地诊疗常规提供VKA
给药途径：口服
用药频次：1次/天
剂量：根据INR调整
用药时程：对于采用直接复律策略的患者，应在随机化后1–5天内进行心脏复律。利伐沙班或VKA在计划直接复律前给药1–5天，复律后给药42天。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 以下事件的复合数量，由中心评估：卒中、短暂性脑缺血发作（TIA）、非中枢神经系统（CNS）全身性栓塞、心肌梗死（MI）和心血管死亡 | 最多100天 | 有效性指标 |
| 大出血事件的数量，由中心评估 | 最多100天 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 卒中及非CNS全身性栓塞复合数量 | 最多100天 | 有效性指标 |
| 卒中、短暂性脑缺血发作、非CNS全身性栓塞、心肌梗死及全因死亡的复合数量 | 最多100天 | 有效性指标 |
| 卒中数量 | 最多100天 | 有效性指标 |
| 短暂性脑缺血发作数量 | 最多100天 | 有效性指标 |
| 非CNS全身性栓塞数量 | 最多100天 | 有效性指标 |
| 心肌梗死数量 | 最多100天 | 有效性指标 |
| 心血管死亡数量 | 最多100天 | 有效性指标 |
| 大出血和非大出血复合数量 | 最多100天 | 安全性指标 |
数据安全监察委员会（DMC）
有
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 | |
|---|---|---|---|---|---|---|---|
| Ricardo Cappato | 教授 | 390252774337 | riccardo.cappato@grupposandonato.it | Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy | 20097 | Center of Clinical Arrythmia & Electrophysiology, I.R.C.C.S. Policlinico San Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| Gruppo Ospedaliero San Donato Foundation | Ricardo Cappato | Italy | Milano | San Donato Milanese |
| Hospital Erasme/Erasmus Ziekenhuis | Philippe VAN DE BORNE | Belgium | BRUXELLES - BRUSSEL | BRUXELLES - BRUSSEL |
| Jessa Ziekenhuis | Johan VIJGEN | Belgium | HASSELT | HASSELT |
| CHR de la Citadelle | Eti？nne HOFFER | Belgium | LIEGE | LIEGE |
| H. Hartziekenhuis Mol | Harry STRIEKWOLD | Belgium | MOL | MOL |
| Grand H？pital de Charleroi | Jean LEROY | Belgium | GILLY | GILLY |
| Hospital Universitário Evangélico de Curitiba | Paulo Roberto Rossi | Brazil | Paraná | Curitiba |
| Loema Instituto de Pesquisa Clinica & Consultores LTDA | Fabio Santos | Brazil | S？o Paulo | Campinas |
| Pontificia Universidade Católica do RS - Centro Clínico | Carlos Ant？nio Kalil | Brazil | Rio Grande do Sul | Porto Alegre |
| Hospital das Clínicas da Faculdade de Medicina da USP | Mauricio Scanavacca | Brazil | Soeo Paulo | Sao Paulo |
| PUC Campinas - Hospital e Maternidade Celso Pierro | José Saraiva | Brazil | Soeo Paulo | Campinas |
| Montreal Heart Institute | Mario Talajic | Canada | Quebec | Montreal |
| Saint John Regional Hospital | Gregory Searles | Canada | New Brunswick | Saint John |
| Hopital Laval | Gilles O'Hara | Canada | Quebec | Quebec |
| Royal Alexandra Hospital | Evan Lockwood | Canada | Alberta | Edmonton |
| St. Michael's Hospital Health Centre | Iqwal Mangat | Canada | Ontario | Toronto |
| Hamilton General Hospital | Stuart Connolly | Canada | Ontario | Hamilton |
| CHUM - Hopital Hotel-Dieu | Benoit Coutu | Canada | Quebec | Montreal |
| Victoria Cardiac Arrhythmia Trails, Inc. | Laurence Sterns | Canada | British Columbia | Victoria |
| Health Sciences Centre - Eastern Health | Sean Connors | Canada | Newfoundland and Labrador | St. John's |
| 首都医科大学附属北京安贞医院 | 马长生 | 中国 | 北京 | 北京 |
| 西安交通大学医学院第一附属医院 | 袁祖贻 | 中国 | 陕西 | 西安 |
| 沈阳军区总医院 | 王祖禄 | 中国 | 辽宁 | 沈阳 |
| 武汉亚洲心脏病医院 | 苏晞 | 中国 | 湖北 | 武汉 |
| 新疆医科大学第一附属医院 | 汤宝鹏 | 中国 | 新疆 | 乌鲁木齐 |
| 中南大学湘雅二医院 | 刘启明 | 中国 | 湖南 | 长沙 |
| 广东省人民医院 | 吴书林 | 中国 | 广东 | 广州 |
| 南昌大学第二附属医院 | 洪葵 | 中国 | 江西 | 南昌 |
| 吉林大学第一医院 | 郑杨 | 中国 | 吉林 | 长春 |
| Regionshospitalet Viborg, Skive, Kjellerup | Jens Refsgaard | Denmark | Viborg | Viborg |
| Regionshospitalet Herning | Ole May | Denmark | Herning | Herning |
| Gentofte Hospital | Gunner Gislason | Denmark | Hellerup | Hellerup |
| H:S Bispebjerg Hospital | Henrik Nielsen | Denmark | Kobenhavn NV | Kobenhavn NV |
| Turun yliopistollinen keskussairaala, kantasairaala | Juhani Airaksinen | Finland | Turku | Turku |
| Etelo -Karjalan keskussairaala | Seppo Utriainen | Finland | Lappeenranta | Lappeenranta |
| Satakunnan keskussairaala | Tuomas Paana | Finland | Pori | Pori |
| Keski-Suomen keskussairaala | Pirjo Mustonen | Finland | Jyvo skylo | Jyvo skylo |
| Lapin keskussairaala | Alexandre Hadjikov | Finland | Rovaniemi | Rovaniemi |
| Oulun yliopisto | Heikki Huikuri | Finland | Oulu | Oulu |
| Vaasan keskussairaala | Juhani Koistinen | Finland | Vaasa | Vaasa |
| Tampereen yliopistollinen sairaala, keskussairaala | Pekka Raatikainen | Finland | Tampere | Tampere |
| HUS, Meilahden sairaala | Mika Lehto | Finland | Helsinki | Helsinki |
| Hospital Cardiologique - Lille Cedex | salem Kacet | France | LILLE CEDEX | LILLE CEDEX |
| Centre Hospitalier - Arras | Abed RIFAI | France | ARRAS | ARRAS |
| Hopital Bichat - Paris | Antoine Leenhardt | France | PARIS | PARIS |
| Institut de cardiologie/Salpétrière | Richard ISNARD | France | Paris cedex 13 | Paris cedex 13 |
| Hospital Cardiologique - Pessac | Frederic Sacher | France | PESSAC | PESSAC |
| Hospital de Rangueil - Toulouse | Meyer ELBAZ | France | TOULOUSE cedex | TOULOUSE cedex |
| Centre Hospitalier Universitaire Brabois | Etienne ALIOT | France | VANDOEUVRE-LES-NANCY | VANDOEUVRE-LES-NANCY |
| H？pital Trousseau - Tours | Laurent FAUCHIER | France | TOURS | TOURS |
| Hopital Saint Antoine - Paris | Stéphane EDERHY | France | PARIS | PARIS |
| Klinikum der Johann Wolfgang Goethe Universit？t Frankfurt | Stefan Hohnloser | Germany | Hessen | Frankfurt |
| Kliniken Maria Hilf GmbH | Jürgen vom Dahl | Germany | Nordrhein-Westfalen | Monchengladbach |
| Charité Campus Virchow-Klinikum (CVK) | Wilhelm Haverkamp | Germany | Berlin | Berlin |
| Universitytsklinikum Essen | Peter Krings | Germany | Nordrhein-Westfalen | Essen |
| University tsklinikum Hamburg Eppendorf (UKE) | Stephan Willems | Germany | Hamburg | Hamburg |
| Universitytsklinikum Freiburg | Thomas Faber | Germany | Baden-Württemberg | Freiburg |
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Cornelia Piper | Germany | Nordrhein-Westfalen | Bad Oeynhausen |
| Krankenhaus Dresden-Friedrichstadt | Sebastian Schellong | Germany | Sachsen | Dresden |
| Kliniken Nord und Süd | Dirk Bastian | Germany | Bayern | Nürnberg |
| University tsklinikum Leipzig A？R | Andreas Bollmann | Germany | Sachsen | Leipzig |
| Johannes-Gutenberg-Universit？t Mainz | Tommaso Gori | Germany | Rheinland-Pfalz | Rheinland-Pfalz |
| University General Hospital of Heraklion | Panagiotis Vardas | Greece | Heraklion | Heraklion |
| Hippokration General Hospital of Thessaloniki | Vassilios Vassilikos | Greece | Thessaloniki | Thessaloniki |
| University General Hospital of Alexandroupolis | Dimitrios Tziakas | Greece | Alexandroupolis | Alexandroupolis |
| Henry Dunant Hospital | George Andrikopoulos | Greece | Attica / Athens | Attica / Athens |
| ARNAS Garibaldi | Michele Massimo Gulizia | Italy | Catania | Catania |
| A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi | Alessandro Capucci | Italy | Ancona | Ancona |
| A.O. Sant'Anna | Giovanni Luca Botto | Italy | Como | San Fermo della Battaglia |
| Ente Ecclesiastico Ospedale Generale Regionale Miulli | Massimo Grimaldi | Italy | Bari | Acquaviva delle Fonti |
| AULSS 12 Veneziana - Veneto | Sakis Themistoclakis | Italy | Venezia | Venezia |
| A.O. Città della Salute e della Scienza di Torino | Fiorenzo Gaita | Italy | Torino | Torino |
| ASL RM/B Roma - Lazio | Leonardo Calò | Italy | Roma | Roma |
| Atrium Medisch Centrum Parkstad | J.A. Kragten | Netherlands | HEERLEN | HEERLEN |
| Academisch Ziekenhuis Maastricht | H.J.G.M. Crijns | Netherlands | MAASTRICHT | MAASTRICHT |
| Medisch Centrum Leeuwarden | R.W. Breedveld | Netherlands | LEEUWARDEN | LEEUWARDEN |
| Ziekenhuis Rijnstate | M. Hemels | Netherlands | ARNHEM | ARNHEM |
| Kennemer Gasthuis, Locatie Zuid | R. Tukkie | Netherlands | HAARLEM | HAARLEM |
| Centro Hospitalar Vila Nova de Gaia | Joeo Primo | Portugal | Vila Nova de Gaia | Vila Nova de Gaia |
| Centro Hospitalar de Lisboa Central-Hospital Santa Marta | Mário Oliveira | Portugal | Lisboa | Lisboa |
| Hospital Garcia da Orta | Luis Brand？o | Portugal | Almada | Almada |
| Centro Hospitalar de Lisboa Ocidental, EPE - H.Santa Cruz | Pedro Pedro Adrago | Portugal | Lisboa | Carnaxide |
| Hospital Distrital de Faro | Walter Santos | Portugal | Faro | Faro |
| Centro Hospitalar Universitario de Coimbra - H. Dos Cov？es | Paula Mota | Portugal | Coimbra | Martinho do Bispo |
| National Heart Centre | Tan Ru San | Singapore | Singapore | Singapore |
| Tan Tock Seng Hospital | David Foo | Singapore | Singapore | Singapore |
| Khoo Teck Puat Hospital | Hean Yee Ong | Singapore | Singapore | Singapore |
| National University Hospital | Swee-Chong Seow | Singapore | Singapore | Singapore |
| Kuils River Hospital | Jan Saaiman | South Africa | Western Cape | Kuils River |
| Clinical Projects Research SA | Louis van Zyl | South Africa | Western Cape | Worcester |
| IATROS | Abraham Barnard | South Africa | Bloemfontein | Bloemfontein |
| Vincent Pallotti Hospital | Adrian Horak | South Africa | Western Cape | Cape Town |
| University of Stellenbosch | Henry Cyster | South Africa | Western Cape | Cape Town |
| Vincent Pallotti Hospital | Saleem Dawood | South Africa | Western Cape | Cape Town |
| Chris Hani Baragwanath Hospital | Mohammed Essop | South Africa | Gauteng | SOWETO |
| Vergelegen Medi-Clinic | Johan Engelbrecht | South Africa | Western Cape | Somerset West |
| Union Hospital | Tjaart Venter | South Africa | Gauteng | Alberton |
| Vergelegen Medi-Clinic | Thomas Mabin | South Africa | Western Cape | Somerset West |
| Hospital Universitario Clinica Puerta de Hierro | Juan Manuel Escudier | Spain | Madrid | Majadahonda |
| Hospital Clínic i Provincial de Barcelona | Lluis Mont | Spain | Barcelona | Barcelona |
| Hospital Universitario Virgen de las Nieves | Luis Tercedor | Spain | Granada | Granada |
| Clínica Universitaria de Navarra | Naiara Calvo Galiano | Spain | Pamplona | Pamplona |
| Corporació Sanitària Parc Taulí | Eva Guillaumet Gasa | Spain | Barcelona | Sabadell |
| Hospital General Universitario Gregorio Mara？ón | Esteban González Torrecilla | Spain | Madrid | Madrid |
| Queen Elizabeth II Hospital | Diana Gorog | United Kingdom | Hertfordshire | Welwyn Garden City |
| Royal Bournemouth General Hospital | Richard Balasubramaniam (Bala) | United Kingdom | Dorset | Bournemouth |
| Queen Alexandra Hospital | Neil Andrews | United Kingdom | Portsmouth | Portsmouth |
| Chesterfield Royal Hospital | Justin Cooke | United Kingdom | Derbyshire | Chesterfield |
| Chesterfield Royal Hospital | Alastair Sandilands | United Kingdom | Leicestershire | Leicester |
| Nottingham City Hospital | Andrew Staniforth | United Kingdom | Nottinghamshire | Nottingham |
| Northampton General Hospital | Patrick Davey | United Kingdom | Cliftonville | Cliftonville |
| St George's Hospital | Irina Irina | United Kingdom | London | London |
| Mid-Ohio Heart Clinic, Inc. | James Bacon | United States | Ohio | Mansfield |
| Rapid City Regional Hospital | John Heilman | United States | South Dakota | Rapid City |
| BryanLGH Medical Center East | Steve Krueger | United States | Nebraska | Lincoln |
| Mobile Heart Specialists, PC | Noel Bedwell | United States | Alabama | Mobile |
| Fox Valley Clinical Research Center, LLC | Santosh Gill | United States | Illinois | Aurora |
| Tallahassee Research Institute | David Smith | United States | Florida | Tallahassee |
| Aultman Hospital | Ira Friedlander | United States | Ohio | Cantan |
| Buffalo Heart Group, LLP | Alan Meholick | United States | New York | Buffalo |
| Santa Rosa Cardiology Medical Group | John Hunter | United States | California | Santa Rosa |
| South Florida Research Solutions, LLC | Adam Splaver | United States | Florida | Hollywood |
| Johns Hopkins University | William Herzog | United States | Maryland | Columbia |
| Regional Cardiology Associates | Arash Aryana | United States | California | Sacramento |
| Center for Cardiovascular Research | Mark Chang | United States | Tennessee | Johnson City |
| Doylestown Hospital | Robert Sangrigoli | United States | Pennsylvania | Doylestown |
| Aspirus Cardiovascular Associates | German Larrain | United States | Wisconsin | Wausau |
| Precision Research Institute, LLC | Jerome Robinson | United States | California | National City |
| TriWest Research Associates | Suhail Zavaro | United States | California | El Cajon |
| Rush University Medical Center | Kousik Krishnan | United States | Illinois | Chicago |
| Silicon Valley Cardiology Medical Group | Rob Patrawala | United States | California | East Palo Alto |
| Cardiovascular Associates | Mohammmed Khan | United States | Illinois | Elk Grove Village |
| Rockford Cardiovascular Associates | Edward Telfer | United States | Illinois | Rockford |
| Columbia University Medical Center | Jose Dizon | United States | New York | New York |
| Scottsdale Healthcare Research Institute | Nassim Haddad | United States | Arizona | Scottsdale |
| Charles George VA Medical Center | Anil Goli | United States | North Carolina | Asheville |
| The Toledo Clinic, Inc. | Ahed Nahhas | United States | Ohio | Toledo |
| New Mexico Heart Institute | Ross Downey | United States | New Mexico | Albuquerque |
| VA Southern Nevada Healthcare System | Javed Tunio | United States | Nevada | North Las Vegas |
| Cardiology Associates of Fairfield County, PC | Mark Heiman | United States | Connecticut | Stamford |
| PeaceHealth St. Joseph Medical Center | John MacGregor | United States | Washington | Bellingham |
| Heritage Valley Heart and Vascular Center | Angel Flores | United States | Pennsylvania | Beaver |
| Office of Dr. Daniel Gottlieb, MD | Daniel Gottlieb | United States | Washington | Burien |
| BHS Cardiovascular Consultants | Sunder Rao | United States | Pennsylvania | Butler |
| Centennial Heart Cardiovascular Consultants | Robert Jones | United States | Tennessee | Nashville |
| Utah Cardiology, PC | Stephanie Olsen | United States | Utah | Layton |
| Vanderbilt University Medical Center | Pablo Saavedra | United States | Tennessee | Nashville |
| The Cleveland Clinic | Allan Klein | United States | Ohio | Cleveland |
| North Texas Heart Center, PA | Jorge Cheirif | United States | Texas | Dallas |
| Tyler Cardiovascular Consultants | Frank Navetta | United States | Texas | Tyler |
| Pinellas Arrhythmia Associates | John Norris | United States | Florida | Clearwater |
| Chinatown Cardiology, PC | Tak Kwan | United States | New York | New York |
| The Cardiovascular Center, PA | William David | United States | Florida | Deltona |
| Shady Grove Adventist Hospital | Sean Beinart | United States | Maryland | Rockville |
| Broward Health Medical Center | Arnoux Arnoux | United States | Florida | Ft. Lauderdale |
| Advanced Heartcare, LLC | Sharan Mahal | United States | New Jersey | Bridgewater |
| Florida Hospital Memorial Medical Center | David Henderson | United States | Florida | Daytona Beach |
| Brooke Army Medical Center | Ahmad Slim | United States | Texas | Fort Sam Houston |
| Alfieri Cardiology | Anthony Alfieri | United States | Delaware | Wilmington |
| Einstein Healthcare Network | Gregg Pressman | United States | Pennsylvania | Philadelphia |
| University of Chicago Hospitals | Hemal Nayak | United States | Illinois | Chicago |
| Penn State Milton S. Hershey Medical Center | Javier Banchs | United States | Pennsylvania | Hershey |
| Holy Cross Hospital | Rishi Anand | United States | Florida | Ft. Lauderdale |
| Anne Arundel Medical Center | Valeriani Bead | United States | Maryland | Annapolis |
| Drexel Cardiology | Steven Kutalek | United States | Pennsylvania | Philadelphia |
| Research One | Babak Vakili | United States | Florida | Orlando |
| Harbor - UCLA Medical Center | William French | United States | California | Torrance |
| Capital Cardiology Associates | Robert Morris | United States | New York | Troy |
| JPAZ Perfection Clinical, LLC | John Covalesky | United States | New Jersey | Manalapan |
| Texas Heart & Vascular | Vinh Nguyen | United States | Texas | Austin |
| Yale University School of Medicine | Mark Marieb | United States | Connecticut | New Haven |
| Health First Physicians, Inc. | Enrique Polanco | United States | Florida | Melbourne |
| East Coast Institute for Research | Ferris George, Jr. | United States | Florida | St. Augustine |
| East Coast Institute for Research | Albert Seals | United States | Florida | Jacksonville |
| Presence Saint Joseph Medical Center | Ahmad Abdul-Karim | United States | Illinois | Joliet |
| Jacksonville Center for Clinical Research | Michael Koren | United States | Florida | Jacksonville |
| Suncoast Research Group, LLC | Hector Jimenez | United States | Florida | Miami |
| Watson Clinic Center for Research | Kevin Browne | United States | Florida | Lakeland |
| Watson Clinic Center for Research | William Wallace | United States | Georgia | Savannah |
| UZ Leuven Gasthuisberg | Hein HEIDBUCHEL | Belgium | Vlaams Brabant | LEUVEN |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 北京安贞医院 | 同意 | 2013-06-20 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 80 人；
国际: 1500 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 65 人 ；
国际: 1504 人；
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：登记人暂未填写该信息；
第一例受试者入组日期
国内：2013.3.29；
国际：2012-10-03；
试验终止日期
国内：2014-02-28；
国际：2014-01-24；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
