基本信息
| 登记号 | CTR20130780 | 试验状态 | 进行中 |
|---|---|---|---|
| 申请人联系人 | Neta R. Nelson | 首次公示信息日期 | 2013-10-21 |
| 申请人名称 | 杭州泰格医药科技有限公司/ BHR Pharma, LLC/ Fresenius Kabi Austria GmbH | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20130780 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | 黄体酮脂肪乳 | ||
| 药物类型 | |||
| 临床申请受理号 | 企业选择不公示 | ||
| 适应症 | 重症创伤性脑损伤 | ||
| 试验专业题目 | 关于黄体酮治疗重症创伤性脑损伤有效性和安全性的随机、双盲、安慰剂对照III期临床研究 | ||
| 试验通俗题目 | 重症创伤性脑损伤患者中静脉用黄体酮的有效性和安全性 | ||
| 试验方案编号 | BHR-100-301 | 方案最新版本号 | |
| 版本日期: | 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 | 1 2 3 | ||||
|---|---|---|---|---|---|
| 联系人姓名 | Neta R. Nelson | 联系人座机 | 请联系泰必达 | 联系人手机号 | 请联系泰必达 |
| 联系人Email | 请联系泰必达 | 联系人邮政地址 | 607 Herndon Parkway, Suite 110 Herndon, VA, USA | 联系人邮编 | 20170 |
三、临床试验信息
1、试验目的
SyNAPSe试验将研究在受伤后8小时内给予静脉（i.v.）黄体酮治疗120小时是否能对重症创伤性脑损伤患者改善其恢复。
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 |
3、受试者信息
| 年龄 | 16/18岁(最小年龄)至 70岁(最大年龄) | ||
|---|---|---|---|
| 性别 | 男+女 | ||
| 健康受试者 | 无 | ||
| 入选标准 | 1 年龄在16岁-70岁（含16岁和70岁）的男女患者（或当地法规要求的最低年龄限）。 2 体重为45-135kg（含45和135kg） 3 研究治疗开始前遭受闭合性头部外伤不超过8小时 4 根据病史及临床检查诊断为TBI 5 复苏术后GCS评分在4-8分（包括） 6 至少有一侧瞳孔有反应 7 因与入院时CT扫描一致的异常情况而证实的TBI（弥漫性损伤II-VI, Marshall CT分级） 8 根据ICP监测指示 | ||
| 排除标准 | 1 研究者判断的预期存活时间不足24小时 2 根据研究者判断，不能或不愿意遵循方案直至完成末次访视的受试者（受伤后6个月） 3 入院后长时间持续和/或不能纠正的低氧（Pa02< 60 mmHg）或低血压（收缩压< 90 mmHg） 4 任何脊髓损伤 5 妊娠 6 穿通性头部外伤 7 随机化时双侧瞳孔散大固定 8 怀疑主要由其它原因引起的昏迷（如酒精） 9 单纯的硬膜外血肿 10 以前存在重大临床疾病或在入院时可确定的慢性疾病，并有可能影响功能预后 11 复苏术后严重的心脏或血流动力学不稳定 12 已知在受伤30天内接受过其它研究药物或手术治疗 13 对黄体酮及相关药物或输液成份有过敏反应史 14 根据研究者的判断，具有任何不稳定或可能危害研究过程中患者安全及其依从性的疾病 | ||
4、试验分组
| 试验药 | 序号 名称 用法 1 中文通用名:黄体酮脂肪乳 用法用量:在第1小时内静输注药的负荷剂量为0.71 mg/kg/hr，然后以 0.5 mg/kg/hr剂量进行119小时的连续维持输注。 |
|---|---|
| 对照药 | 序号 名称 用法 1 中文通用名:不含黄体酮的脂肪乳 用法用量:在第1小时内安慰剂的负荷剂量为0.71 mg/kg/hr，然后以 0.5 mg/kg/hr剂量进行119小时的连续维持输注。 |
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 格拉斯哥预后评分 受伤后6个月 企业选择不公示 |
|---|---|
| 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 GOS评价 TBI后3个月时 企业选择不公示 2 GOS-E评价 TBI后3个月及6个月 企业选择不公示 3 SF-36 TBI后第3个月和6个月 企业选择不公示 4 ICP、CPP及TIL变化 入院及第6天输液后 企业选择不公示 5 CT扫描判断的颅内病理改变 入院及第6天输液后 企业选择不公示 6 死亡率 TBI后1个月及6个月 企业选择不公示 |
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
无
四、研究者信息
1、主要研究者信息
暂未填写此信息
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家或地区 | 省（州） | 城市 |
|---|---|---|---|---|---|
| 1 | Groupe Hospitalier Pellegrin | France | Aquitaine | Bordeaux | |
| 2 | H？pital Central – CHU de Nancy | France | Limousin, Lorraine | Nancy | |
| 3 | H？pital Pierre Wertheimer | France | Rhone-Alpes | Bron | |
| 4 | Berufsgenossenschaftliche Kliniken | Germany | Sachsen-Anhalt | Halle | |
| 5 | Charité – Universit？tsmedizin Berlin | Germany | Berlin | Berlin | |
| 6 | Klinikum der J.W. Goethe-Universit？t | Germany | Hessen | Frankfurt | |
| 7 | Klinikum Nürnberg | Germany | Bayern | Nürnberg | |
| 8 | Krankenhaus Merheim | Germany | Nordrhein-Westfalen | K？ln | |
| 9 | Niels-Stensen-Kliniken | Germany | Niedersachsen | Osnabrück | |
| 10 | Universit？tsklinikum Gie？en und Marburg gGmbH | Germany | Hessen | Marburg | |
| 11 | Universit？tsklinikum Hamburg-Eppendorf | Germany | Hamburg | Hamburg | |
| 12 | Universit？tsklinikum Heidelberg | Germany | Baden-Wuerttemberg | Heidelberg | |
| 13 | Universit？tsklinikum Ulm | Germany | Baden-Wuerttemberg | Ulm | |
| 14 | Universit？tsmedizin G？ttingen | Germany | Niedersachsen | G？ttingen | |
| 15 | Honvédelmi Minisztérium állami Egészségügyi K？zpont | Hungary | Budapest | Budapest | |
| 16 | Pécsi Tudományegyetem általános Orvostudományi Kar | Hungary | Baranya | Pécs | |
| 17 | Szegedi Tudományegyetem Szent-Gy？rgyi Albert Klinikai K？zpont | Hungary | - | Szeged | |
| 18 | Chaim Sheba Medical Center | Israel | - | Tel-Hashomer | |
| 19 | Hadassah Medical Organization | Israel | - | Jerusalem | |
| 20 | Rabin Medical Center | Israel | - | Petach-Tikva | |
| 21 | Rambam Medical Center | Israel | - | Haifa | |
| 22 | Tel Aviv Sourasky Medical Center | Israel | - | Tel Aviv | |
| 23 | Azienda Ospedaliera San Camillo Forlanini | Italy | - | Rome | |
| 24 | Azienda Ospedaliera San Gerardo | Italy | - | Monza | |
| 25 | Azienda Ospedaliero Universitaria Integrata di Verona | Italy | - | Verona | |
| 26 | Azienda Ospedaliero Universitaria Maggiore della Caritá | Italy | - | Novara | |
| 27 | zienda Ospedaliero Universitaria de Parma | Italy | - | Parma | |
| 28 | Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena | Italy | - | Milano | |
| 29 | Fondazione San Raffaele del Monte Tabor | Italy | - | Milano | |
| 30 | Ospedale Generale Regionale di Bolzano | Italy | - | Bolzano | |
| 31 | VU Medisch Centrum | Netherlands | Noord-Holland | Amsterdam | |
| 32 | Universitair Medisch Centrum Groningen | Netherlands | Groningen | Groningen | |
| 33 | Spitalul Clinic Judetean de Urgenta Timisoara | Romania | Timis | Timisoara | |
| 34 | Saint Petersburg Healthcare Institution “City Mariinsky Hospital” | Russia | - | St. Petersburg | |
| 35 | State Budget Educational Institution of Higher Professional Education “Kemerovskaya State Medical Academy of Federal Agency of Healthcare and Social Development” | Russia | - | Kemerovo | |
| 36 | State Budgeted Educational Institution of Higher Professional Education “Altai State Medical University” of Ministry of Health Care and Social Development of the Russian Federation | Russia | - | Barnaul | |
| 37 | State Educational Institution of High Professional Education “Bashkir State Medical University” | Russia | - | Ufa | |
| 38 | State Healthcare Facility “Murmansk Regional Clinical Hospital n.a. Bayandin” | Russia | - | Murmansk | |
| 39 | State Institution “Burdenko Neurosurgical Institute of RAMS” | Russia | - | Moscow | |
| 40 | State Institution of Health Care “Sverdlovsk Regional Clinical Hospital #1” | Russia | - | Yekaterinburg | |
| 41 | State Professional Institution of High Professional Education “Krasnoyarsk State Medical University named after Prof. V.F. Voyno-Yasenetsky of Ministry of Health and Social Development” | Russia | - | Krasnoyarsk | |
| 42 | Hospital Clínico Universitario De Valencia | Spain | - | Valencia | |
| 43 | Hospital General Universitario de Alicante | Spain | - | Alicante | |
| 44 | Hospital Parc Taulí | Spain | Barcelona | Sabadell | |
| 45 | Hospital Universitari i Politecnic La Fé de Valencia | Spain | - | Valencia | |
| 46 | Hospital Universitario de Bellvitge | Spain | - | Barcelona | |
| 47 | Hospital Universitario de Gran Canaria Dr. Negrín | Spain | - | Las Palmas de Gran Canaria | |
| 48 | Hospital Universitario 12 de Octubre | Spain | - | Madrid | |
| 49 | Hospital Universitario Germans Trias i Pujol | Spain | Barcelona | Badalona | |
| 50 | Hospital Universitario de Girona Dr. Josep Trueta | Spain | - | Girona | |
| 51 | Hospital Universitari Son Espases | Spain | Baleares | Palma de Mallorca | |
| 52 | Hospital Universitario del Valle de Hebrón | Spain | - | Barcelona | |
| 53 | Hospital Universitario Virgen del Rocio | Spain | - | Sevilla | |
| 54 | Leeds Teaching Hospitals NHS, Leeds General Infirmary | United Kingdom | England | Leeds | |
| 55 | 成都军区总医院 | 中国 | 四川 | 成都 | |
| 56 | 天津医科大学总医院 | 中国 | 天津 | 天津 | |
| 57 | 复旦大学附属华山医院 | 中国 | 上海 | 上海 | |
| 58 | 徐州医学院附属医院 | 中国 | 江苏 | 徐州 | |
| 59 | 福建医学院附属第一医院 | 中国 | 福建 | 福州 | |
| 60 | 上海交通大学医学院附属仁济医院 | 中国 | 上海 | 上海 | |
| 61 | 浙江大学医学院附属第二医院 | 中国 | 浙江 | 杭州 | |
| 62 | 山东大学第二医院 | 中国 | 山东 | 济南 | |
| 63 | Hospital Kuala Lumpur | Malaysia | Kuala Lumpur | Kuala Lumpur | |
| 64 | Hospital Raja Permaisuri Bainun | Malaysia | Perak | Ipoh | |
| 65 | Hospital Tengku Ampuan Afzan | Malaysia | Pahang | Kuantan | |
| 66 | Sarawak General Hospital | Malaysia | Sarawak | Kuching | |
| 67 | University Malaya Medical Centre | Malaysia | Kuala Lumpur | Kuala Lumpur | |
| 68 | National Neuroscience Institute | Singapore | Singapore | Singapore | |
| 69 | National University Hospital | Singapore | Singapore | Singapore | |
| 70 | Singapore General Hospital | Singapore | Singapore | Singapore | |
| 71 | National Taiwan University Hospital | 中国 | - | Taipei | |
| 72 | Taichung Veterans General Hospital | 中国 | - | Taichung | |
| 73 | Taipei Medical University – Wan Fang Hospital | 中国 | - | Taipei | |
| 74 | Hospital Central de Mendoza | Argentina | Mendoza | Mendoza | |
| 75 | Hospital Dr. José Maria Cullen | Argentina | Santa Fe | Santa Fe | |
| 76 | Hospital de Emergencias Clemente Alvarez (HECA) | Argentina | Santa Fe | Rosario | |
| 77 | Hospital Francisco Lopez Lima | Argentina | Rio Negro | General Roca | |
| 78 | Hospital Nacional “Profesor Alejandro Posadas” | Argentina | Buenos Aires | Buenos Aires | |
| 79 | Hospital Regional De Comodoro Rivadavia (HRCR) | Argentina | Chubut | Comodoro Rivadavia | |
| 80 | Hospital San Martin | Argentina | Entre Rios | Paraná | |
| 81 | Landesklinikum Wiener Neustadt | Austria | Lower Austria | Vienna | |
| 82 | Medizinische Universit？t Graz | Austria | Styria | Graz | |
| 83 | Medizinische Universit？t Innsbruck | Austria | Tyrol | Innsbruck | |
| 84 | Unfallkrankenhaus Salzburg | Austria | - | Salzburg | |
| 85 | ULB Erasme | Belgium | Brussels | Brussels | |
| 86 | Universitair Ziekenhuis Gent | Belgium | Oost-Vlaanderen | Gent | |
| 87 | University Hospital of the Free University Brussels (UZ Brussel) | Belgium | Brussels | Jette | |
| 88 | University Hospital Gasthuisberg | Belgium | Flemish Brabant | Leuven | |
| 89 | Ziekenhuis Oost-Limburg, Location Sint Jan | Belgium | Limburg | Genk | |
| 90 | Fakultní nemocnice Brno Neurochirurgická klinika | Czech Republic | - | Brno | |
| 91 | Fakultní nemocnice Královské Vinohrady | Czech Republic | - | Praha | |
| 92 | Fakultní nemocnice Plzeň, Neurochirurgicé odd？lení | Czech Republic | - | Plzeň | |
| 93 | Fakultní nemocnice u sv. Anny v Brn？, Neurochirurgická klinika | Czech Republic | - | Brno | |
| 94 | Tampere University Hospital | Finland | Western Finland | Tampere | |
| 95 | Centre Hospitalier Universitaire H？pital Nord | France | Provence Alpes Cote D’Azur | Marseille | |
| 96 | Centre Hospitalier Universitaire de Grenoble- Hópital Michallon | France | Rhone-Alpes | Grenoble | |
| 97 | Centre Hospitalier Universitaire de Limoges | France | Limousin, Lorraine | Limoges | |
| 98 | University of Oklahoma Medical Center | United States | Oklahoma | Oklahoma City | |
| 99 | Queen Elizabeth Hospital | United Kingdom | England | Birmingham | |
| 100 | Royal Preston Hospital | United Kingdom | England | Fulwood, Preston | |
| 101 | Southampton University Hospital | United Kingdom | England | Southampton | |
| 102 | The James Cook University Hospital | United Kingdom | England | Middlesbrough | |
| 103 | The Royal London Hospital | United Kingdom | England | London | |
| 104 | University Hospital Coventry | United Kingdom | England | Coventry | |
| 105 | University of South Alabama Medical Center | United States | Alabama | Mobile | |
| 106 | LAC+USC Medical Center | United States | California | Los Angeles | |
| 107 | University of California San Diego Medical Center | United States | California | San Diego | |
| 108 | Denver Health Medical Center | United States | Colorado | Denver | |
| 109 | Christiana Care Health System Hospital | United States | Delaware | Newark | |
| 110 | Delray Medical Center | United States | Florida | Delray Beach | |
| 111 | Tallahassee Memorial Healthcare | United States | Florida | Tallahassee | |
| 112 | Tampa General Hospital | United States | Florida | Tampa | |
| 113 | John H. Stroger, Jr., Hospital of Cook County | United States | Illinois | Chicago | |
| 114 | Advocate Lutheran General Hospital | United States | Illinois | Park Ridge | |
| 115 | Saint John’s Hospital | United States | Illinois | Springfield | |
| 116 | Wishard Health Services | United States | Indiana | Indianapolis | |
| 117 | Methodist Hospital | United States | Indiana | Indianapolis | |
| 118 | Mercy Medical Center | United States | Iowa | Des Moines | |
| 119 | University of Iowa Hospitals and Clinics | United States | Kansas | Iowa City | |
| 120 | University of Kansas Medical Center | United States | Kansas | Kansas City | |
| 121 | University of Louisville Clinical Research Center | United States | Kentucky | Louisville | |
| 122 | Eastern Maine Medical Center | United States | Maine | Bangor | |
| 123 | Maine Medical Center | United States | Maine | Portland | |
| 124 | Baystate Medical Center | United States | Massachusetts | Springfield | |
| 125 | University of Massachusetts Memorial Medical Center | United States | Massachusetts | Worcester | |
| 126 | Bronson Methodist Hospital | United States | Michigan | Kalamazoo | |
| 127 | University of Missouri Health Care | United States | Missouri | Columbia | |
| 128 | Lester E. Cox Memorial Hospital | United States | Missouri | Springfield | |
| 129 | Nebraska Medical Center | United States | Nebraska | Omaha | |
| 130 | Robert Wood Johnson University Hospital | United States | New Jersey | New Brunswick | |
| 131 | Albany Medical Center Hospital | United States | New York | Albany | |
| 132 | New York Medical College | United States | New York | Valhalla | |
| 133 | Mission Hospital | United States | North Carolina | Asheville | |
| 134 | Carolinas Medical Center | United States | North Carolina | Charlotte | |
| 135 | Duke University Medical Center | United States | North Carolina | Durham | |
| 136 | Wake Forest University-Baptist Medical Center | United States | North Carolina | Winston-Salem | |
| 137 | Summa Health System | United States | Ohio | Akron | |
| 138 | MetroHealth Medical Center | United States | Ohio | Cleveland | |
| 139 | Miami Valley Hospital | United States | Ohio | Dayton | |
| 140 | Saint Elizabeth Health Center | United States | Ohio | Youngstown | |
| 141 | CHRU de Lille- Hópital Roger Salengro | France | Nord Pas-de-Calais | Lille | |
| 142 | Groupe Hospitalier La Salpêtrière | France | Ile-de-France | Paris | |
| 143 | Legacy Emmanuel Hospital | United States | Oregon | Portland | |
| 144 | University of Pittsburgh Medical Center | United States | Pennsylvania | Pittsburgh | |
| 145 | Allegheny General Hospital | United States | Pennsylvania | Pittsburgh | |
| 146 | Medical University of South Carolina | United States | South Carolina | Charleston | |
| 147 | Palmetto Clinical Trial Services | United States | South Carolina | Columbia | |
| 148 | Johnson City Medical Center | United States | Tennessee | Johnson City | |
| 149 | Vanderbilt University Medical Center | United States | Tennessee | Nashville | |
| 150 | University Medical Center of El Paso | United States | Texas | El Paso | |
| 151 | University of Virginia Health System | United States | Virginia | Charlottesville | |
| 152 | Cabell Huntington Hospital | United States | West Virginia | Huntington | |
| 153 | West Virginia University Hospital | United States | West Virginia | Morgantown | |
| 154 | University of Wisconsin Hospital and Clinics | United States | Madison | Wisconsin |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | na | 2011-06-23 |
六、试验状态信息
1、试验状态
进行中 （招募中）
2、试验人数
| 目标入组人数 | |
|---|---|
| 已入组人数 | 国际: 登记人暂未填写该信息； |
| 实际入组总人数 | 国际: 登记人暂未填写该信息； |
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 | 国际：登记人暂未填写该信息； |
|---|---|
| 第一例受试者入组日期 | 国际：登记人暂未填写该信息； |
| 试验完成日期 | 国际：登记人暂未填写该信息； |
七、临床试验结果摘要
| 序号 | 版本号 | 版本日期 |
|---|---|---|
| 暂未填写此信息 | ||
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