免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / 达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究
达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究
基本信息
| 登记号 | CTR20131054 | 试验状态 | 已完成 |
|---|---|---|---|
| 申请人联系人 | 汪涛 | 首次公示信息日期 | 2014-04-02 |
| 申请人名称 | 百时美施贵宝（中国）投资有限公司/ Bristol-Myers Squibb Company | ||
公示的试验信息
一、题目和背景信息
| 登记号 | CTR20131054 | ||
|---|---|---|---|
| 相关登记号 | |||
| 药物名称 | 达沙替尼 | ||
| 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 | 新诊断的成人慢性期慢性髓性白血病患者 | ||
| 试验专业题目 | 比较达沙替尼和伊马替尼治疗新诊断的慢性髓细胞白血病慢性期受试者的随机、多中心、开放性3 期临床研究 | ||
| 试验通俗题目 | 达沙替尼和伊马替尼治疗慢性髓细胞白血病的对照研究 | ||
| 试验方案编号 | CA180-056 | 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
|
||||
|---|---|---|---|---|---|
| 联系人姓名 | 汪涛 | 联系人座机 | 010-65632538 | 联系人手机号 | |
| 联系人Email | Tao.wang4@bms.com | 联系人邮政地址 | 北京市朝阳区建外大街永安里甲16号CBD国际大厦18层 | 联系人邮编 | 100022 |
三、临床试验信息
1、试验目的
在新诊断的慢性期Ph+ CML受试者中，比较达沙替尼和伊马替尼治疗
12个月的完全细胞遗传学缓解（CCyR）率。同时观察治疗的安全性。
2、试验设计
| 试验分类 | 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 | 开放 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 年龄 | 18岁(最小年龄)至 105岁(最大年龄) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 性别 | 男+女 | ||||||||||||||||||
| 健康受试者 | 无 | ||||||||||||||||||
| 入选标准 |
|
||||||||||||||||||
| 排除标准 |
|
||||||||||||||||||
4、试验分组
| 试验药 |
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 对照药 |
|
5、终点指标
| 主要终点指标及评价时间 |
|
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 次要终点指标及评价时间 |
|
6、数据安全监查委员会（DMC）
无
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
| 1 | 姓名 | 王建祥 | 学位 | 职称 | 主任医师 | |
|---|---|---|---|---|---|---|
| 电话 | 022-23909120 | wangjx@ihcams.ac.cn | 邮政地址 | 天津市南京路288号 | ||
| 邮编 | 300020 | 单位名称 | 中国医学科学院血液病医院 | |||
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 | 福建协和医院 | 中国 | 福建 | 福州 | |
| 2 | 中国医学科学院血液病医院 | 王建祥 | 中国 | 天津 | 天津 |
| 3 | 北京大学人民医院 | 中国 | 北京 | 北京 | |
| 4 | 上海瑞金医院 | 沈志祥 | 中国 | 上海 | 上海 |
| 5 | 上海瑞金医院 | 中国 | 上海 | 上海 | |
| 6 | 北京大学人民医院 | 黄晓军 | 中国 | 北京 | 北京 |
| 7 | 福建协和医院 | 胡建达 | 中国 | 福建 | 福州 |
| 8 | Hospital Britanico | Bullorsky, Eduardo | Argentina | BUENOS AIRES | Buenos Aires |
| 9 | Hospital Italiano La Plata | Milone, Jorge | Argentina | BUENOS AIRES | La Plata |
| 10 | Hospital General De Agudos J.M. Ramos Mejia | Moiraghi, Beatriz | Argentina | BUENOS AIRES | Capital Federal |
| 11 | Fundaleu | Pavlovsky, Carolina | Argentina | BUENOS AIRES | Capital Federal |
| 12 | Royal Brisbane &Women'S Hospital | Durrant, Simon Trevor | Australia | Queensland | Brisbane |
| 13 | Royal Perth Hospital | Herrmann, Richard | Australia | Western Australia | Perth |
| 14 | Nicol, Andrew | Nicol, Andrew | Australia | Queensland | Greenslopes |
| 15 | Southern Health-Monash Medical Centre | Opat, Stephen | Australia | Victoria | Clayton |
| 16 | The Canberra Hospital | Prosser, Ian | Australia | ACT | WODEN |
| 17 | Newcastle Mater Misericordiae Hospital | Rowlings, Philip | Australia | New South Wales | Waratah |
| 18 | The Mater Private Centre For Haematology & Oncology | Taylor, Kerry | Australia | Queensland | South Brisbane |
| 19 | Universitaetsklinikum Innsbruck | Gastl, Guenther | Austria | Innsbruck | Innsbruck |
| 20 | Universitaetsklinik Salzburg | Greil, Richard | Austria | Salzburg | Salzburg |
| 21 | Klinikum Kreuzschwestern Wels | Thaler, Josef | Austria | Wels | Wels |
| 22 | Department Fuer Haematologie | Valent, Peter | Austria | Wien | Wien |
| 23 | Cliniques Universitaires Saint-Luc | Ferrant, Augustin | Belgium | Bruxelles | Bruxelles |
| 24 | Az Sint-Jan | Van Droogenbroeck, Jan | Belgium | Brugge | Brugge |
| 25 | Santa Casa De Misericordia De Sao Paulo | Chiattone, Carlos Sergio | Brazil | Sao Paulo | Sao Paulo |
| 26 | Fundacao Hospital Amaral Carvalho | Colturato, Vergílio | Brazil | Sao Paulo | Jau |
| 27 | Universidade Estadual De Campinas | De Souza, Carmino | Brazil | Sao Paulo | Campinas |
| 28 | Hospital Das Clinicas - Fundacao Pro-Sangue - Hemocentro | Dorlhiac Llacer, Pedro E | Brazil | Sao Paulo | Sao Paulo |
| 29 | Hospital Das Clínicas De Ribeir？o Preto | Falc？o, Roberto Passeto | Brazil | Sao Paulo | Ribeir？o Preto |
| 30 | Instituto Nacional De Cancer | Moellmann-Coelho, Arthur | Brazil | Rio De Janeiro | Rio De Janeiro |
| 31 | Hosp Clin Univ Fed Do Parana | Pasquini, Ricardo | Brazil | Parana | Curitiba |
| 32 | Hospital Das Clínicas De Porto Alegre - Ufrs | Silva, Lucia Mariano | Brazil | Rio Grande Do Sul | Porto Alegre |
| 33 | Hospital Brigadeiro | Zanichelli, Maria Aparecida | Brazil | Sao Paulo | Sao Paulo |
| 34 | Oncomed | Orlandi, Francisco | Chile | METROPOLITANA | Santiago |
| 35 | Hospital Del Salvador | Undurraga, Maria Soledad | Chile | METROPOLITANA | Santiago |
| 36 | Instituto Nacional De Cancerologia | Enciso, Leonardo | Colombia | Bogota | Bogota |
| 37 | Clinica Colombia | Ramirez, Carlos | Colombia | Bogota | Bogota |
| 38 | Fakultni Nemocnice Olomouc | Faber, Edgar | Czech Republic | Olomouc | Olomouc |
| 39 | Ustav Hematologie A Krevni Transfuze | Klamova, Hana | Czech Republic | Prague 2 | Prague 2 |
| 40 | University Hospital | Mayer, Jiri | Czech Republic | Brno - Bohunice | Brno - Bohunice |
| 41 | Fakultni Nemocnice Hradec Kralove | Voglova, Jaroslava | Czech Republic | Hradec Kralove | Hradec Kralove |
| 42 | Aalborg Univ Hosp | Helleberg Rasmussen, Inge | Denmark | Aalborg | Aalborg |
| 43 | Odense University Hospital | Marcher, Claus | Denmark | Odense | Odense |
| 44 | Aarhus University Hospital | Stentoft, Jesper | Denmark | Aarhus C | Aarhus C |
| 45 | Hopital Morvan | Berthou, Christian | France | Brest Cedex 02 | Brest Cedex 02 |
| 46 | Chu Dupuytren | Bordessoule, Dominique | France | Limoges | Limoges |
| 47 | Institut Paoli-Calmettes | Charbonnier, Aude | France | Marseille Cedex 9 | Marseille Cedex 9 |
| 48 | Hotel Dieu - Chu De Nantes | Dubruille, Viviane | France | Na | Nantes Cedex 1 |
| 49 | Chu Pontchaillou | Escoffre-Barbe, Martine | France | Rennes | Rennes |
| 50 | Centre Hospitalier Regional Et Universitaire De Lille | Facon, Thierry | France | Lille Cedex | Lille Cedex |
| 51 | C H R U De Nancy Hopital De Brabois | Guerci-Bresler, Agnes | France | Vandoeuvre Les Nancy | Vandoeuvre Les Nancy |
| 52 | Centre Investigation Clinique | Guilhot, Francois | France | Poitiers Cedex | Poitiers Cedex |
| 53 | Hopital Civil | Herbrecht, Raoul | France | Na | Strasbourg |
| 54 | Chu Purpan - Hopital Casselardit | Huguet, Francoise | France | Toulouse Cedex 09 | Toulouse Cedex 09 |
| 55 | Hopital Necker | Lefrere, Francois | France | Paris | Paris |
| 56 | Centre Hospitalier Lyon Sud | Michallet, Mauricette | France | Pierre Benite Cedex | Pierre Benite Cedex |
| 57 | Hopital Saint Eloi | Quittet, Philippe | France | Na | Montpellier Cedex 5 |
| 58 | Hopital Saint Louis | Rea, Delphine | France | Na | Paris Cedex 10 |
| 59 | Medizinische Hochschule Hannover | Ganser, Arnold | Germany | Hannover | Hannover |
| 60 | Universitaet Rostock Med Fakultaet | Junghanss, Christian | Germany | Rostock | Rostock |
| 61 | Campus Virchow Klinikum Der Charite | Le Coutre, Philipp | Germany | Berlin | Berlin |
| 62 | Med. Klinik 2 | Soekler, Martin | Germany | Tuebingen | Tuebingen |
| 63 | Universitaetsklinikum Ulm | Stegelmann, Frank | Germany | Ulm | Ulm |
| 64 | Medizinische Universitaetsklinik Freiburg | Waller, Cornelius | Germany | Freiburg | Freiburg |
| 65 | General Peripheral Hospital George Papanikolaou | Anagnostopoulos, Achilleas | Greece | Thessaloniki | Thessaloniki |
| 66 | General Hospital Gennimatas | Anagnostopoulos, Nikolaos | Greece | Athens | Athens |
| 67 | General Hospital Of Athens Evangelismos | Nikiforakis, Emmanuel | Greece | Athens | Athens |
| 68 | University Of Pecs | David, Mariann | Hungary | Pecs | Pecs |
| 69 | Fovarosi Egyesitett Szent Istvan Es Szent Laszlo Korhaz Es R | Fekete, Sandor | Hungary | Budapest | Budapest |
| 70 | Fovarosi Egyesitett Szent Istvan Es Szent Laszlo Korhaz Es R | Masszi, Tamas | Hungary | Budapest | Budapest |
| 71 | Semmelweis Korhaz 2 Belgyogyaszat Es Haematologia | Radvanyi, Gaspar | Hungary | Miskolc | Miskolc |
| 72 | Debreceni Egyetem Orvos-és Egészségtudományi Centrum | Udvardy, Miklos | Hungary | Debrecen | Debrecen |
| 73 | Hematology Clinic | Agarwal, Usha | India | Mumbai | Mumbai |
| 74 | Lakeshore Hospital & Research Centre Ltd | Gangadharan, V . P | India | Cochin | Cochin |
| 75 | All India Institute Of Medical Sciences | Kumar, Rajat | India | New Delhi | New Delhi |
| 76 | Christian Medical College | Mathews, Vikram | India | Vellore | Tamilnadu |
| 77 | Regional Cancer Centre | Narayanan, Geetha | India | Trivandrum | Trivandrum |
| 78 | Tata Memorial Hospital | Prabhash, Kumar | India | Mumbai | Mumbai |
| 79 | Prince Aly Khan Hospital | Saikia, Tapan | India | Mumbai | Mumbai |
| 80 | Vedanta Institute Of Medical Sciences | Shah, Sandip | India | Ahmedabad | Ahmedabad |
| 81 | Ospedale S.Eugenio | Abruzzese, Elisabetta | Italy | Roma | Roma |
| 82 | Universita' Degli Studi Sapienza Di Roma | Alimena, Giuliana | Italy | Rome | Rome |
| 83 | Azienda Ospedaliera Universitaria Careggi | Bosi, Alberto | Italy | Firenze | Firenze |
| 84 | Universita' Di Bologna | Cavo, Michele | Italy | Bologna | Bologna |
| 85 | Ospedale Ferrarotto | Di Raimondo, Francesco | Italy | Catania | Catania |
| 86 | Azienda Ospedaliera San Gerardo | Gambacorti-Passerini, Carlo | Italy | Monza (mb) | Monza (mb) |
| 87 | Ospedale Policlinico Consorziale | Liso, Vincenzo | Italy | Bari | Bari |
| 88 | Ospedale Niguarda Ca'Granda | Morra, Enrica | Italy | Milano | Milano |
| 89 | Irccs Policlinico S Matteo | Orlandi, Ester Maria | Italy | Pavia | Pavia |
| 90 | Azienda Ospedaliera San Luigi Gonzaga | Saglio, Giuseppe | Italy | Orbassano (to) | Orbassano (to) |
| 91 | Yokohama City University Medical Center | Fujisawa, Shin | Japan | KANAGAWA | Yokohama |
| 92 | Iwate Medical University Hospital | Ishida, Yoji | Japan | IWATE | Morioka-shi |
| 93 | Tohoku University Hospital | Ishizawa, Kenichi | Japan | Miyagi | Sendai-City |
| 94 | Saitama Medical Center, Jichi Medical University | Kanda, Yoshinobu | Japan | SAITAMA | Saitama |
| 95 | Kameda Clinic Of Medical Corporation Tesshokai | Matsue, Kosei | Japan | CHIBA | Kamogawa-shi |
| 96 | Osaka City University Hospital | Nakamae, Hirohisa | Japan | OSAKA | Osaka-shi |
| 97 | Tokyo Metropolitan Komagome Hospital | Ohashi, Kazuteru | Japan | TOKYO | Bunkyo-ku |
| 98 | Fukuoka University Hospital | Tamura, Kazuo | Japan | FUKUOKA | Fukuoka |
| 99 | Okayama University Hospital | Tanimoto, Mitsune | Japan | OKAYAMA | Okayama-shi |
| 100 | University Hospital Kyoto Prefectural University Of Medicine | Taniwaki, Masafumi | Japan | KYOTO | Kyoto-shi |
| 101 | Nagoya Daini Red Cross Hospital | Uchida, Toshiki | Japan | AICHI | Nagoya |
| 102 | Ntt Medical Center Tokyo | Usuki, Kensuke | Japan | TOKYO | Shinagawa-ku |
| 103 | Imamura Bun-In Hospital | Utsunomiya, Atae | Japan | KAGOSHIMA | Kagoshima-shi |
| 104 | Instituto Nacional De Ciencias Medicas Y Nutricion S.Z. | Aguayo Gonzalez, Alvaro | Mexico | Distrito Federal | Delegacion Tlalpan |
| 105 | Centro Medico Nacional La Raza | Ayala Sanchez, Jose Luis Manuel | Mexico | Distrito Federal | Mexico |
| 106 | Instituto Nacional De Cancerologia | Cervera, Eduardo | Mexico | Distrito Federal | Mexico City |
| 107 | Hospital Universitario Dr. Jose Eleuterio Gonzalez | Gomez Almaguer, David | Mexico | Nuevo Leon | Monterrey |
| 108 | Clinica N°25 Imss | Hernandez Valdes, Roberto | Mexico | Nuevo Leon | Monterrey |
| 109 | Hospital General De Mexico | Kassack Ipina, Juan Julio | Mexico | Distrito Federal | Mexico, D. F. |
| 110 | Centro Medico Nacional Siglo Xxi | Meillon Garcia, Luis Antonio | Mexico | Distrito Federal | Mexico, D. F. |
| 111 | Hospital General De Culiacan Dr. Bernardo J. Gastelum | Rivas Llamas, Ramon | Mexico | Sinaloa | Culiacan |
| 112 | Umc Nijmegen | Schattenberg, A.V.M.B | Netherlands | Nijmegen | Nijmegen |
| 113 | Umc Groningen | Vellenga, Edo | Netherlands | Groningen | Groningen |
| 114 | Instituto Nacional De Enfermedades Neoplasicas | Casanova, Luis | Peru | Lima | Lima |
| 115 | Hospital Nacional Alberto Seguin -Essalud Arequipa | Malaga Zenteno, Jose | Peru | Arequipa | Arequipa |
| 116 | Hospital Nacional Edgardo Rebagliati Martins | Navarro, Juan | Peru | Lima | Lima |
| 117 | Zespot Szpitali Miejskich | Grosicki, Sebastian | Poland | Chorzow | Chorzow |
| 118 | Odz. Hematologii I Chorob Rozrostowych Ukl.Krwiotworczego | Komarnicki, Mieczyslaw | Poland | Poznan | Poznan |
| 119 | Klinika Hematologii Um W Lodzi, Woj.Szpital Spec | Robak, Tadeusz | Poland | Lodz | Lodz |
| 120 | Oddzial Kliniczny Kliniki Hematologii | Skotnicki, Aleksander | Poland | Krakow | Krakow |
| 121 | Klinika Hematologii Instytutu Hematologii I Transfuzjologii | Warzocha, Krzysztof | Poland | Warsaw | Warsaw |
| 122 | The Catholic University Of Korea , Seoul St. Mary'S Hospital | Kim, Dong-Wook | Republic of Korea | Seoul | Seoul |
| 123 | Asan Medical Center | Lee, Kyoo-Hyung | Republic of Korea | Seoul | Seoul |
| 124 | Spitalul Clinic Coltea Clinica De Hematologie | Anca Roxana, Lupu | Romania | Bucuresti | Bucuresti |
| 125 | Spitalul Municipal De Urgenta Timisoara Clinica De Hematolog | Ionita, Hortensia Marioara | Romania | Timisoara | Timisoara |
| 126 | Institutul Oncologic Ioan Chiricuta Clinica De Hematologie | Petrov, Liubomir | Romania | Cluj Napoca | Cluj Napoca |
| 127 | Institutul Clinic Fundeni Centrul De Hematologie | Stoia, Razvan | Romania | Bucuresti | Bucuresti |
| 128 | Russian Research Institute Of Hematology And Transfusiology | Abdylkadirov, Kudrat | Russian Federation | Saint-petersburg | Saint-petersburg |
| 129 | Moscow Region Research Clinical Institute | Golenkov, Anatoly | Russian Federation | Moscow | Moscow |
| 130 | National Research Hematology Center | Khoroshko, Nina | Russian Federation | Moscow | Moscow |
| 131 | Novosibirsk State Medical University | Pospelova, Tatiana | Russian Federation | Novosibirsk | Novosibirsk |
| 132 | Rostov State Medical University | Shatokhin, Yuri | Russian Federation | Rostov-on-don | Rostov-on-don |
| 133 | St.Pet State Medical University Named Afteri.P Pavlov | Zaritskey, Andrey Yu | Russian Federation | St.petersburg | St.petersburg |
| 134 | Hospital Del Mar | Alvarez, Alberto | Spain | Barcelona | Barcelona |
| 135 | Instituto Catalan De Oncologia | Boque, Concepcion | Spain | Barcelona | Barcelona |
| 136 | Hospital Clinic I Provincial | Cervantes, Francisco | Spain | Barcelona | Barcelona |
| 137 | Hospital Universitario La Paz | De Paz, Raquel | Spain | Madrid | Madrid |
| 138 | Hospital Universitario De Salamanca | Del Canizo, Consuelo | Spain | Salamanca | Salamanca |
| 139 | Hospital Carlos Haya De Malaga | Jimenez-Velasco, Antonio | Spain | Malaga | Malaga |
| 140 | Hospital Universitario Y Politecnico La Fe | Martinez-Dominguez, Jesus | Spain | Valencia | Valencia |
| 141 | Hospital Son Dureta | Novo, Andres | Spain | Palma De Mallorca | Palma De Mallorca |
| 142 | Comp. H. U. De Santiago | Perez, Manuel | Spain | Santiago De Compostela | Santiago De Compostela |
| 143 | Hosp Univ Virgen Macarena | Portero, Mari Angeles | Spain | Sevilla | Sevilla |
| 144 | Hospital General De Asturias | Ramirez Payer, Angel | Spain | Oviedo | Oviedo |
| 145 | Hospital Universitario De La Princesa | Steegmann, Juan Luis | Spain | Madrid | Madrid |
| 146 | Erciyes Universitesi Tip Fakultesi | Cetin, Mustafa | Turkey | Kayseri | Kayseri |
| 147 | Osmangazi Universitesi Tip Fakultesi | Gulbas, Zafer | Turkey | Eskisehir | Eskisehir |
| 148 | Hacettepe Universitesi Tip Fakultesi | Haznedaroglu, Ibrahim C | Turkey | Ankara | Ankara |
| 149 | Istanbul Universitesi Cerrahpasa Tip Fakultesi | Soysal, Teoman | Turkey | Istanbul | Istanbul |
| 150 | Singapore General Hospital | Chuah, Charles Thuan Heng | Singapore | Singapore | Singapore |
五、伦理委员会信息
