PROSERA 研究

意在改善肺动脉高压患者的生活

搜索研究地点

欢迎参加 PROSERA 研究

希望这些信息对您有用。如果您有兴趣参加本项研究，请点击此处以查看研究摘要。您可以下载或打印此摘要，然后将其带去与您的医生或专科医生讨论。

研究介绍

什么是 PROSERA 研究？

PROSERA 研究是一项 3 期临床试验研究，旨在帮助研究者了解一种名为塞拉替尼 (Seralutinib)* 的吸入性研究医学产品未来是否可以安全、有效地用于治疗成年肺动脉高压患者。

认识了解肺动脉高压

肺动脉高压是一种罕见的进展性疾病，当为肺供血的小血管内细胞过度生长时，这种疾病就产生了。这种过度生长导致动脉变得更窄、更硬，扰乱了通过心脏和肺部的血流。

导致肺动脉高压发病和进展的途径有三个，三者相互关联，分别是：炎症、增殖和纤维化。当身体损伤激活免疫系统以启动修复过程时，就会出现炎症。在肺动脉高压患者体内，这种炎症反应被异常激活并导致肺血管壁内细胞过度增长，这种现象被称为增殖。细胞的增殖引发血管壁增厚，导致肺部小动脉变得狭窄、紧缩，进而最终造成组织的灵活性改变。随着疾病进展，这些血管壁会出现疤痕、变得僵硬，这个现象被称为纤维化。肺动脉高压的症状包括呼吸短促、胸痛、疲劳和/或乏力。

观看 Luke Howard 教授（肺科顾问医生）对于肺动脉高压的详细讲解

试验用研究药物

PROSERA 研究是一项随机双盲临床试验，这意味着每位参与者将被随机分配去接受塞拉替尼或安慰剂。为了对照这两个治疗组的表现，必须保证参与者和研究医生都不知道参与者将接受哪种治疗。这是标准做法，有助于防止医生在评估参与者结果时失之偏颇，提高了研究结果的可靠性。

塞拉替尼
我们希望通过 PROSERA 研究了解塞拉替尼对体内导致与肺动脉高压相关的炎症、增殖和纤维化的特异性途径的影响。目前还没有靶向所有这些特异性途径的治疗方案。

开展本项研究是为了观察往当前已获批准的治疗方案加入塞拉替尼，是否可以经由阻断这些途径来预防或逆转肺动脉高压的影响。塞拉替尼被制成微小的干粉，用小型手持设备吸入给药。研究过程中，我们也希望了解塞拉替尼的安全性和耐受性。

安慰剂
安慰剂看起来像活性药物，但不含任何活性药物。使用安慰剂的意义在于，让研究团体可以用一种标准化的方法比较塞拉替尼的有效性和安全性。

本项研究有哪些安排？

研究的每个阶段都会要求您接受一些检测和程序。这些检测旨在跟踪您的健康状况和病情改善，可能包括以下检测项目：

病史和体检

血检和尿检

6 分钟步行测试

此项检测将要求您在 6 分钟内步行尽可能远的距离

超声心动图和心电图

旨在提供心脏影像并检查心率和心律的检测

肺功能检测

此项检测将要求您做深呼吸，然后对着一台机器吹气以测量您的肺功能水平

右心导管检查

一个旨在测量肺内血压和心脏右侧的血流和功能的程序。筛选时必须接受右心导管检查，除非您在最近 6 个月内已接受过这项检查

* 塞拉替尼尚未被美国美国食品药品监督管理局 (FDA) 以及任何其他监管机构批准做商业用途。

我有参与资格吗？

请回答下列问题以确定您是否有资格参加 PROSERA 研究。

回答完所有问题后，请点击 “提交”。. 请注意，点击“提交” 并不意味着您同意参加本项研究。

问题 1

您是不是年龄在 18 岁至 75 岁的成人？

问题 2

您是否已被确诊肺动脉高压？

问题 3

您是否正在接受至少一种针对肺动脉高压疾病的药物治疗？

问题 4

您的身体质量指数 (BMI) 是否在 17 至 40 kg/m2 之间？

如果您不确定您的 BMI 数据，请点击 此处 以帮助您计算您的身体质量指数

问题 5

您有可能正在怀孕吗？

问卷已提交

感谢您提交问卷。

×

基于您的回答内容，我们认为您 可能 有资格参加 PROSERA 研究. 如果您有兴趣参加 PROSERA 研究. 请咨询您的医生。点击 此处 以查看摘要，您可以下载或打印此摘要，然后将其带去与您的医生或专科医生讨论。

×

基于您的回答内容，我们认为您 目前可能不符合 我们认为您目前可能不符合参加本项研究的条件。如果日后您对这些问题的回答有任何变化，请重新答题以再次接受资格评估。如果您已被确诊肺动脉高压且仍有兴趣参加 PROSERA 研究, 请联系您的医生或专科医生， 他们或许能为您提供进一步的建议。感谢您关注 PROSERA 研究. 谢谢您。

后续响应

如果您认为本项临床试验研究可能适合您并且您也有兴趣参加，请下载此摘要或将其发送给您的医生或专科医生以做进一步讨论。

PROSERA 研究时间表

PROSERA 研究将持续开展至少 24 周，包括筛选、治疗和随访约诊环节。

本项研究包含 4 个部分：

1

筛选

最长 4 周

Circle

筛选

最长 4 周

预筛选

  • 您将被要求在筛选前 12 周内继续按照当前的肺动脉高压用药方案进行治疗，剂量不变。

确认您有参加本项研究的资格

  • 筛选期，最长 4 周
  • 全面体检，包括病史讨论
  • 血样和尿样检测
  • 对您的心脏和肺进行检测和检查（例如超声心动图和心电图、6 分钟步行测试 和肺功能检测）
  • 筛选时必须接受右心导管检查，除非您在最近 6 个月内已接受过这项检查

2

治疗期

最短 24 周

Circle

治疗期

最短 24 周

研究期

  • 筛选结束后，您将被随机化分组以接受塞拉替尼或安慰剂胶囊，每天两次，通过干粉吸入器吸入给药
  • 整个研究过程中，您将被要求完成检查约诊，这是为了监测您的病情并评估研究药物的安全性
  • 您和研究医生都不知道您将接受哪种药物
  • 本项研究将持续最长 48 周或者直至 PROSERA 研究中的最后一名患者结束 24 周治疗

3a

随访

最后一剂治疗后第 4 周左右

Circle

随访

最后一剂治疗后第 4 周左右

接受最后一剂治疗后

  • 如果您决定不参加 PROSERA-EXT 研究（开放标签扩展研究），则您需要在接受完最后一剂治疗后的第 4 周左右完成一次随访约诊
  • 在您停止接受治疗之后，研究医生可以通过随访监测您的健康状况
  • 检测项目可能包括全面体检以及血样和尿样检测

3b

PROSERA-EXT

长期研究

Circle

PROSERA-EXT

长期研究

开放标签扩展研究

  • 一旦您结束了主研究，您将有机会加入一项名为 PROSERA-EXT 的开放标签扩展 (OLE) 研究的机会
  • 您将有机会继续使用塞拉替尼或者（如果您先前使用的是安慰剂）改用塞拉替尼

4

研究结束

Circle

研究结束

结果

  • 研究结束并且研究报告制作完毕之后，研究结果将公布在以下网站上：https://euclinicaltrials.eu 以及 http://www.ClinicalTrials.gov
  • 一旦本项研究对所有参与者终结，您将可以从您的研究医生处获悉，您接受的是塞拉替尼还是安慰剂

4

研究结束

Circle

研究结束

结果

  • 研究结束并且研究报告制作完毕之后，研究结果将公布在以下网站上：https://euclinicaltrials.eu 以及 http://www.ClinicalTrials.gov
  • 一旦本项研究对所有参与者终结，您将可以从您的研究医生处获悉，您接受的是塞拉替尼还是安慰剂

研究地点

搜索

输入您所在城市的名称或邮政编码，地图上会以蓝色小点显示离您最近的研究中心。

Kurume University Hospital

Distance

Address:

Kurume University Hospital, Pharmaceutical Department, ６７ Asahi-machi, Kurume-shi, Fukuoka 830-0011

获得指引

Hospital Universitario San Ignacio

Distance

Address:

Carrera 7 No. 40-62, Oficina 726. Investigaciones, Bogota, Bogota 110231

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Fundacion Neumologica Colombiana

Distance

Address:

Carrera 13 B Numero 161-85, Piso 3. Usaquen, Bogota, Bogota 110131

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LMU Klinikum Großhadern, Med. V

Distance

Address:

Marchininistr. 15, München, 81377

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Fundacion Clinica Shaio

Distance

Address:

Diagonal 115A 70 C 75, Bogota, Colombia 111121

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Hospital São Paulo

Distance

Address:

Rua Napoleão De Barros 715, Vila Clementino, Sao Paulo, Sao Paulo 04024-002

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Instituto do Coração - HCFMUSP

Distance

Address:

Avenida Doutor Enéas Carvalho De Aguiar 155 , 1 Andar. Cerqueira César, Sao Paulo, Sao Paulo 05403-000

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Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Distance

Address:

Avenida Ipiranga 6690, Centro de Pesquisa Clinica. 4º Andar, Porto Alegre, Rio Grande do Sul 90610-000

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Hospital Dia do Pulmão

Distance

Address:

Rua Engenheiro Paul Werner 1141, Itoupava Seca, Blumenau, Santa Catarina 89030-101

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Nagoya University Hospital

Distance

Address:

Nagoya University Hospital, Center for Advanced Medicine and Clinical Research, 65 Tsurumai-cho, Showa-ku, Nagoya-Shi, Aichi 466-8560

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The University of Tokyo Hospital

Distance

Address:

The University of Tokyo Hospital, Clinical Research Promotion Center, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655

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Kyorin University Hospital

Distance

Address:

Kyorin University Hospital, Clinical Trial Management Office, 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611

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Evangelismos General Hospital of Athens

Distance

Address:

Ypsilantou 45-47, , 3rd Floor Pateras Building, 1st Intensive Care Unit Department, Athens, 10676, Athina, Attiki 106 76

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Mater Misericordiae University Hospital (MMUH)

Distance

Address:

Eccles Street, Phibsborough, Dublin 7, Dublin, Ireland D07 R2WY

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AKH Wien - Medizinische Universität Wien

Distance

Address:

Währinger Gürtel 18-20, Innere Medizin II – Kardiologie, Ebene 6, 6.L2.07, Vienna, Vienna 1090

获得指引

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

Distance

Address:

Strada di Fiume 447, Polo Cardiologico - S.C. Cardiologia, 1st Floor, Trieste, Friuli-Venezia Giulia 34149

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Royal Free Hospital

Distance

Address:

Rheumatology Office, Pond Street, Lower Ground, Room 301, London, N/A NW3 2QG

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Royal Hallamshire Hospital

Distance

Address:

Glossop Road, Clinical Research Facility (STH22777), Sheffield, S10 2JF

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Freeman Hospital

Distance

Address:

Freeman Road, High Heaton, Newcastle Upon Tyne, Tyne and Wear NE7 7DN

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University Health Network, Toronto General Hospital

Distance

Address:

200 Elizabeth Street, 12EN-240, Toronto, Ontario M5G 2C4

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Peter Lougheed Centre

Distance

Address:

Peter Lougheed Centre, 3500 26 Ave NE, Respiratory Research Rm 1100, Calgary, Alberta T1Y 6J4

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Brigham and Womens Hospital

Distance

Address:

15 Francis St. , Carrie Hall CA-310, Boston, Massachusetts 02115

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ABRAF - Brazilian Pulmonary Hypertension and Related Diseases Association

Distance

Address:

R. Dr. Virgílio de Carvalho Pinto, 445 - Pinheiros, São Paulo - SP, 05415-030, Brazil

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Peter Lougheed Centre

Distance

Address:

3500 26 Ave NE, Rm 1100, Calgary, Alberta T1Y 6J4

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University of Ottawa Heart Institute

Distance

Address:

40 Ruskin St, Pulmonary Hypertension Dept, Ottawa, Ontario K1Y 4W7

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NHO Okayama Medical Center

Distance

Address:

NHO Okayama Medical Center, Clinical Study Management, Main Building 3F, 1711-1 Tamasu, Kita-ku, Okayama-shi, Okayama 701-1192

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Penn Pulmonary Vascular Disease Program

Distance

Address:

3737 Market St, Philadelphia, Pennsylvania 19104

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The Wesley Research Institute

Distance

Address:

451 Coronation Drive, Level 8, East Wing, Auchenflower, QLD 4066

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Klinikum der Universität zu Köln, Herzzentrum, PAH-Ambulanz

Distance

Address:

Kerpener Str. 62, 50937 Köln, Germany

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King Fahad Medical City

Distance

Address:

Makkah Al Mukarramah Branch Road, As, Sulaymaniyah, Riyadh, 12231

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Rhode Island Hospital

Distance

Address:

593 Eddy St, Providence, RI 02903, United States

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King Faisal Specialist Hospital and Research Center

Distance

Address:

Al Takhassusi Street, Riyadh, 11211

获得指引

UT Health Science Center, San Antonio

Distance

Address:

7703 Floyd Curl Dr, San Antonio, TX 78229, United States

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LHSC

Distance

Address:

800 Commissioners Rd E Rm E1633, London, ON N6A 5W9, Canada

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Aarhus Universitetshospital

Distance

Address:

Palle Juul-Jensens Blvd. 99, 8200 Aarhus, Denmark

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Instituto Cardiovascular de Buenos Aires

Distance

Address:

Av. del Libertador 6302, C1428 Cdad. Autónoma de Buenos Aires, Argentina

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Mediprax Centrum

Distance

Address:

Strada Petru Maior 6-8, Cluj-Napoca 400002, Romania

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University of Cincinnati

Distance

Address:

200 Albert Sabin Way, Suite 1001, Cincinnati, Ohio 45267

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Tufts Medical Center

Distance

Address:

800 Washington St, Boston, MA 02111, United States

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INSTITUTUL INIMII

Distance

Address:

Calea Moților 19-21, Cluj-Napoca 400001, Romania

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AHEPA University General Hospital of Thessaloniki

Distance

Address:

Kiriakidi 1, Thessaloniki 546 36, Greece

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Instituto Medico Rio Cuarto

Distance

Address:

Hipólito Yrigoyen 1020, X5800 Río Cuarto, Córdoba, Argentina

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Attikon University General Hospital

Distance

Address:

Rimini 1, Chaidari 124 62, Greece

获得指引

Emergency Institute of Cardiovascular Diseases Prof. Dr. C. C. Iliescu

Distance

Address:

258 Fundeni Road, Bucharest, Bucharest 22328

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Hospital Universitario 12 de Octubre

Distance

Address:

Av. de Córdoba, s/n, Usera, 28041 Madrid, Spain

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Institute of Cardiovascular Diseases (Dedinje)

Distance

Address:

Heroja Milana Tepića 1, Beograd, Serbia

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Clinic of Cardiology, University Clinical Center of Serbia

Distance

Address:

Dr Koste Todorovića 8, Beograd, Serbia

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Irmandade Da Santa Casa de Misericordia de Porto Alegre

Distance

Address:

Rua Professor Annes Dias, 295 - 2° andar - Centro Histórico, Porto Alegre - RS, 90020-090, Brazil

获得指引

National Cerebral and Cardiovascular Center

Distance

Address:

6-1 Kishibeshinmachi, Suita, Osaka 564-8565, Japan

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Hospital Universitario de Toledo

Distance

Address:

Av. del Río Guadiana, 45007 Toledo, Spain

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Hospital Universitari i Politecnic La Fe de Valencia

Distance

Address:

Avinguda de Fernando Abril Martorell, 106, Quatre Carreres, 46026 València, Spain

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Royal Papworth Hospital NHS Foundation Trust

Distance

Address:

Papworth Rd, Trumpington, Cambridge CB2 0AY

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Krankenhaus Neuwittelsbach

Distance

Address:

Renatastraße 71A, 80639 München, Germany

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Universitätsmedizin Greifswald

Distance

Address:

Ferdinand-Sauerbruch-Straße , Klinik und Poliklinik für Innere Medizin B, Greifswald, Greifswald 17475

获得指引

Universitätsklinikum des Saarlandes

Distance

Address:

Kirrberger Str. 100, 66424 Homburg, Germany

获得指引

Hospital Universitario Dr. Jose Eleuterio González

Distance

Address:

Av. Dr. José Eleuterio González S/N, Mitras Centro, 64460 Monterrey, N.L., Mexico

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Unidad de Investigación Clínica En Medicina SC

Distance

Address:

De La Clínica 2520, Sertoma, 64718 Monterrey, N.L., Mexico

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Instituto Nacional de Cardiologia Dr. Ignacio Chavez

Distance

Address:

Belisario Domínguez Secc 16, 14080 Mexico City, CDMX, Mexico

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Ochsner Medical Center

Distance

Address:

1514 Jefferson Hwy, Jefferson, LA 70121, United States

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The Medical Research Group, Inc. 

Distance

Address:

7151 N Cedar Ave, Fresno, CA 93720, USA

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UAB Medicine

Distance

Address:

20th St Community Health Services Bldg, 930 20th St S, Birmingham, AL 35294, United States

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Baylor Scott & White Medical Center - Plano

Distance

Address:

1100 Allied Dr, Plano, TX 75093, United States

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Winchester Center for Lung Disease

Distance

Address:

789 Howard Avenue Fitkin, Building 209, New Haven, CT 06519, United States

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Baylor University Medical Center

Distance

Address:

3410 Worth St, Dallas, TX 75246, USA

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University Of Iowa Hospitals And Clinics

Distance

Address:

Iowa City, IA 52242, United States

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Temple University Hospital

Distance

Address:

3509 N Broad St, Philadelphia, PA 19140, United States

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Mayo Clinic Jacksonville

Distance

Address:

4500 San Pablo Rd S, Jacksonville, FL 32224, United States

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University of Maryland Medical Center

Distance

Address:

110 South Paca St, Baltimore, MD 21201, USA

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Enroll SpA - PPDS

Distance

Address:

Dr. Manuel Barros Borgoño 160, 7500587 Providencia, Región Metropolitana, Chile

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Instituto de Investigaciones Clinicas Quilmes

Distance

Address:

Sarmiento 315, B1878 Quilmes, Provincia de Buenos Aires, Argentina

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Royal Hobart Hospital

Distance

Address:

Cardiology Department, Level 2 48 Liverpool Street, Hobart, Tasmania 7000

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Vseobecna Fakultni Nemocnice V Praze

Distance

Address:

U Nemocnice 2, Ii. Interni Klinika Kardiologie A Angiologie Vfn A 1.lf Uk, Praha, Praha, hlavní mesto 128 08

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Rigshospitalet

Distance

Address:

Inge Lehmanns Vej 7, Clinic for heartdiseases , 2142, Copenhagen East, Capital 2100

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Fondazione IRCCS Policlinico San Matteo

Distance

Address:

Viale Golgi, 19, UOC Cardiology,DEA building,third floor,tower B , Pavia, 27100

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Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi-Via Massarenti

Distance

Address:

Via Massarenti 9, Cardiologic department, 21 building, Bologna, Emilia-Romagna 40138

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Azienda Ospedaliera Monaldi

Distance

Address:

Via Leonardo Bianchi, 80131 Napoli NA, Italy

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Royal Brompton Hospital

Distance

Address:

Sydney Street, Pulmonary Hypertension Service, London, London SW3 6NP

获得指引

Golden Jubilee National Hospital

Distance

Address:

Agamemnon Street, R&D, Glasgow, West Dunbartonshire G81 4DY

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Universitätsklinikum Halle (Saale)

Distance

Address:

Ernst-Grube-Str. 40, Halle , Sachsen-Anhalt 06120

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Universitätsklinikum Dresden

Distance

Address:

Fetscherstr. 74, Dresden, Dresden 01307

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Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg

Distance

Address:

Röntgenstraße 1, Zentrum für pulmonale Hypertonie, Heidelberg, Heidelberg 69126

获得指引

DRK Kliniken Berlin Westend

Distance

Address:

Spandauer Damm 130, Kardiologie/Hochhaus 6.Etage , Berlin, Berlin 14050

获得指引

Universitätsklinikum Hamburg-Eppendorf

Distance

Address:

Martinistr. 52, Zentrum für Onkologie, Studienzentrale Pneumologie, Hamburg, Hamburg 20246

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Universitätsklinikum Giessen und Marburg GmbH

Distance

Address:

Klinikstr. 33, Gießen, Hessen 35392

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Medizinische Hochschule Hannover

Distance

Address:

Carl-Neuberg Straße 1, Klinik für Pneumologie und Infektiologie, Hannover, Hannover 30625

获得指引

Intermountain Medical Center

Distance

Address:

5121 Cottonwood St, Murray, UT 84107, United States

获得指引

University of Southern California-Keck School of Medicine

Distance

Address:

1640 Marengo St Ste 700, Los Angeles, California 90033-1057

获得指引

University of Missouri Health Care

Distance

Address:

One Hospital Drive, Medicine- Pulmonary Environment, CE432, Columbia, Missouri 65212

获得指引

University of Illinois at Chicago

Distance

Address:

909 S Wolcott Ave, Chicago, IL 60612, United States

获得指引

Massachusetts General Hospital

Distance

Address:

55 Fruit St, Boston, MA 02114, United States

获得指引

VA Greater Los Angeles Healthcare System - Cardiology

Distance

Address:

11301 Wilshire Blvd, Bldg. 500, Cardiology Section 111-E Room 4438, Los Angeles, California 90073

获得指引

Stanford University Medical Center

Distance

Address:

300 Pasteur Dr, Stanford, California 94305-2200

获得指引

The George Washington University Medical Faculty Associates

Distance

Address:

2150 Pennsylvania Ave NW , Suite 4-412, Washington, District of Columbia 20037

获得指引

Emory Clinic

Distance

Address:

1365 Clifton Rd NE, Atlanta, Georgia 30322-1013

获得指引

Medical College of Wisconsin

Distance

Address:

8701 W Watertown Plank Rd, Medicine- Pulmonary and Critical Care, 8th Floor of Hub, Milwaukee, Wisconsin 53226

获得指引

Washington University School of Medicine - Center for Advanced Medicine

Distance

Address:

660 S Euclid Ave, MSC 8052-43-14, Saint Louis, Missouri 63110

获得指引

UPMC Presbyterian Hospital

Distance

Address:

200 Lothrop St, Pittsburgh, PA 15213, United States

获得指引

University of Colorado - Health Sciences Center

Distance

Address:

12605 East 16th Avenue, Pulmonary Hypertension Clinic, Aurora, Colorado 80045

获得指引

University of North Carolina at Chapel Hill

Distance

Address:

UNC at Chapel Hill , 130 Mason Farm Road, CB 7020, Chapel Hill, North Carolina 27599

获得指引

Inova Fairfax Hospital

Distance

Address:

3300 Gallows Rd, Falls Church, VA 22042, United States

获得指引

Cleveland Clinic

Distance

Address:

9500 Euclid Ave, Cleveland, OH 44106, United States

获得指引

National University of Singapore

Distance

Address:

5 Lower Kent Ridge Road, Singapore, Singapore 119082

获得指引

National Heart Centre

Distance

Address:

5 Hospital Drive, Singapore, Singapore 169609

获得指引

Pontificia Universidad Catolica de Chile

Distance

Address:

Portugal 61, 8320000 Santiago, Región Metropolitana, Chile

获得指引

Hospital Privado Centro Médico de Córdoba S.A

Distance

Address:

Cordoba, Provincia de Cordoba X5016KEH

获得指引

Nepean Hospital

Distance

Address:

Nepean Hospital, Cardiac Services Level 5, Building C, NSW, 2747

获得指引

Onassis Cardiac Surgery Center

Distance

Address:

Leof. Andrea Siggrou 356, Kallithea 176 74, Greece

获得指引

Institut Klinicke A Experimentalni Mediciny

Distance

Address:

Vídeňská 1958, 140 21 Praha 4, Czechia

获得指引

Ordensklinikum Linz Elisabethinen

Distance

Address:

Fadingerstraße 1, 4020 Linz, Austria

获得指引

VU University Medical Center

Distance

Address:

De Boelelaan 1117, 1081 HV Amsterdam, Netherlands

获得指引

Erasmus University Medical Center

Distance

Address:

Dr. Molewaterplein 40, Rotterdam, Zuid-Holland 3015 GD

获得指引

Hospital Universitario Vall d'Hebron

Distance

Address:

Vall d'Hebron 119-129, Barcelona, Barcelona 08035

获得指引

IRCCS Opsedale Policlinico San Martino

Distance

Address:

Largo Rosanna Benzi 10, Genova, Liguria 16132

获得指引

Klinikum Würzburg Mitte gGmbH

Distance

Address:

Salvatorstraße 7, 97074 Würzburg, Germany

获得指引

Northwestern University

Distance

Address:

240 E Huron St, Chicago, IL 60611, USA

获得指引

University of Minnesota

Distance

Address:

420 Delaware Street MMC 508 Minneapolis, MN 55455, Minnesota, Minnesota

获得指引

Norton Pulmonary Specialists

Distance

Address:

100 W Market St Ste 2, Louisville, Kentucky 40202-1332

获得指引

Duke University Medical Center

Distance

Address:

330 Trent Dr, Durham, NC 27710, USA

获得指引

Medical University of South Carolina

Distance

Address:

96 Jonathan Lucas St, Charleston, SC 29425, USA

获得指引

St. Luke's Health - Baylor St. Luke's Medical Center - Houston, TX

Distance

Address:

7200 Cambridge St, Houston, TX 77030, USA

获得指引

Cardiologia Palermo

Distance

Address:

Comunidad Autonoma de Buenos Aires, Ciudad Autonoma de Buenos Aires C1425BNG

获得指引

Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

Distance

Address:

Borowa 14/18, 05-400 Otwock, Poland

获得指引

UZ Leuven Campus Gasthuisberg

Distance

Address:

Herestraat 49, 3000 Leuven, Belgium

获得指引

Complejo Asistencial Universitario de Salamanca – H. Clinico

Distance

Address:

P.º de San Vicente, 58, 37007 Salamanca, Spain

获得指引

Hospital Universitario Marques de Valdecilla

Distance

Address:

Av. de Valdecilla, s/n, 39008 Santander, Cantabria, Spain

获得指引

Puerta de Hierro Majadahonda University Hospital

Distance

Address:

C. Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain

获得指引

Hammersmith Hospital

Distance

Address:

72 Du Cane Rd, London W12 0HS

获得指引

University of Connecticut

Distance

Address:

263 Farmington Ave, Farmington, CT 06032, USA

获得指引

Aurora Saint Luke's Medical Center

Distance

Address:

2900 W Oklahoma Ave, Milwaukee, WI 53215, United States

获得指引

University of Nebraska Medical Center

Distance

Address:

42nd and, Emile St, Omaha, NE 68198, United States

获得指引

UC Davis Health Medical Center

Distance

Address:

Pulmonary, Critical Care and Sleep Medicine Research , Sacramento, California 95817

获得指引

University of Rochester

Distance

Address:

601 Elmwood Ave, Rochester, NY 14642, USA

获得指引

Allegheny General Hospital

Distance

Address:

320 E North Ave, Pittsburgh, PA 15212, United States

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Centro Hospitalar de Santo António

Distance

Address:

Largo do Prof. Abel Salazar, 4099-001 Porto, Portugal

获得指引

Hospital Universitario Son Espases

Distance

Address:

Carretera de Valldemossa, 79, Nord, 07120 Palma, Illes Balears, Spain

获得指引

Northside Hospital

Distance

Address:

1000 Johnson Ferry Rd NE, Atlanta, GA 30342, USA

获得指引

NYU Langone Health

Distance

Address:

462 1st Ave., New York, NY 10016, USA

获得指引

Sanatorio Parque S.A.

Distance

Address:

Blvd. Oroño 860, S2000 Rosario, Santa Fe, Argentina

获得指引

Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil

Distance

Address:

1 Pl. de l'Hôpital, 67000 Strasbourg, France

获得指引

Hospital Provincial Dr. Jose Maria Cullen

Distance

Address:

Av. Gdor. Freyre 2138, S3000EOM S3000EOM, Santa Fe, Argentina

获得指引

INTEGRIS Family Care Central

Distance

Address:

3400 Northwest Expy Building C, Suite 500, Oklahoma City, OK 73112, United States

获得指引

Mayo Clinic

Distance

Address:

200 1st St SW, Rochester, MN 55905, United States

获得指引

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Distance

Address:

Bolívar 1334, W3400CDS Corrientes, Argentina

获得指引

Tel Aviv Sourasky Medical Center

Distance

Address:

Weizmann St 6, Tel Aviv-Yafo, Israel

获得指引

Meir MC

Distance

Address:

Tchernichovsky St 59, Kefar Sava, 4428164, Israel

获得指引

The Chaim Sheba Medical Center

Distance

Address:

Derech Sheba 2, Ramat Gan, Israel

获得指引

Hadassah University Hospital Ein-Karem

Distance

Address:

Kalman Ya'akov Man St, Jerusalem, Israel

获得指引

Lady Davis Carmel Medical Center

Distance

Address:

Mikhal St 7, Haifa, 3436212, Israel

获得指引

Rabin Medical Center

Distance

Address:

ז'בוטינסקי 39, Petah Tikva, 4941492, Israel

获得指引

Seoul National University Hospital

Distance

Address:

101 Daehak-ro, Jongno-gu, Seoul, South Korea

获得指引

Samsung Medical Center

Distance

Address:

81 Irwon-ro, Gangnam-gu, Seoul, South Korea

获得指引

Gachon University Gil Medical Center

Distance

Address:

21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea

获得指引

Severance Hospital Yonsei University Health System

Distance

Address:

50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea

获得指引

Asan Medical Center

Distance

Address:

88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea

获得指引

The Catholic University of Korea, Seoul St. Mary's Hospital

Distance

Address:

222 Banpo-daero, Seocho-gu, Seoul, South Korea

获得指引

Macquarie University Hospital

Distance

Address:

Level 3, 75 Talavera Rd, Macquarie Park NSW 2113, Australia

获得指引

St Vincents Hospital Melbourne

Distance

Address:

41 Victoria Parade, Fitzroy VIC 3065, Australia

获得指引

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Distance

Address:

Eivenių g. 2, 50161 Kaunas, Lithuania

获得指引

P.Stradins Clinical University Hospital

Distance

Address:

Pilsoņu iela 13, Zemgales priekšpilsēta, Rīga, LV-1002, Latvia

获得指引

Piedmont Healthcare

Distance

Address:

275 Collier Rd NW unit 450, Atlanta, GA 30309, United States

获得指引

Centro Hospital Universitário de Coimbra, EPE

Distance

Address:

Praceta Professor Mota Pinto, 3004-561 Coimbra, Portugal

获得指引

Centro Hospitalar de Vila Nova de Gaia e Espinho

Distance

Address:

R. Conceição Fernandes S/N, 4434-502 Vila Nova de Gaia, Portugal

获得指引

Centro Hospitalar de Lisboa Norte E.P.E – Hospital Pulido Valente

Distance

Address:

Alameda das Linhas de Torres 117, 1769-001 Lisboa, Portugal

获得指引

Targu-Mures Emergency Clinical County Hospital

Distance

Address:

Strada Gheorghe Marinescu 50, Târgu Mureș 540136, Romania

获得指引

Krakowski Szpital Specjalistyczny im. Sw.Jana Pawla II

Distance

Address:

Prądnicka 80, 31-202 Kraków, Poland

获得指引

Hôpital Erasme (Cliniques Universitaires de Bruxelles)

Distance

Address:

Rte de Lennik 808, 1070 Bruxelles, Belgium

获得指引

Hospital Universitario Virgen del Rocio

Distance

Address:

Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

获得指引

Hospital Costa del Sol

Distance

Address:

A-7, Km 187, 29603 Marbella, Málaga, Spain

获得指引

Hospital Clinic de Barcelona

Distance

Address:

Carrer de Villarroel, 170, 08036 Barcelona, Barcelona, Spain

获得指引

Azienda Ospedaliero Universitaria Policlinico Umberto I

Distance

Address:

Viale del Policlinico, 155, 00161 Roma RM, Italy

获得指引

CHU de LILLE-Institut Cœur Poumon

Distance

Address:

Bd du Professeur Jules Leclercq, 59000 Lille, France

获得指引

CHU de Nancy-Hopital Brabois Adulte

Distance

Address:

4 Av. de Bourgogne, 54500 Vandœuvre-lès-Nancy, France

获得指引

CHRU de Poitiers La Miletrie

Distance

Address:

2 Rue de la Milétrie, 86000 Poitiers, France

获得指引

Centre Hospitalier Universitaire de Bicêtre

Distance

Address:

78 Rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France

获得指引

CHU Montpellier- Hôpital Arnaud de VIlleneuve

Distance

Address:

371 Avenue du Doyen Gaston Giraud, Montpellier, Hérault, France

获得指引

Hôpital Pasteur

Distance

Address:

Hôpital Pasteur, 30 Voie Romaine, Nice, France

获得指引

Allianze Pulmonary Research, LLC

Distance

Address:

Maramar Plaza Bldg, Suite 200, Guaynabo, San Juan 00968

获得指引

University of California Irvine

Distance

Address:

333 City Blvd W Ste 400, Orange, California 92868-2994, United States

获得指引

Oregon Health and Science University

Distance

Address:

3181 Southwest Sam Jackson Park Road, Portland, Oregon 97239, United States

获得指引

Wexner Medical Center at The Ohio State University

Distance

Address:

410 W 10th Ave, Columbus, Ohio 43210-1240, United States

获得指引

Jeffrey S. Sager, MD Medical Corporation

Distance

Address:

2428 Castillo St. Ste D, Santa Barbara, California 93105-5311, United States

获得指引

University of New Mexico Health Sciences Center

Distance

Address:

915 Camino de Salud, NE, Albuquerque, NM 87131, United States

获得指引

Houston Methodist Hospital

Distance

Address:

6550 Fannin St, Houston, TX 77030, United States

获得指引

University of Michigan

Distance

Address:

South State Street, Ann Arbor, MI 48109, United States

获得指引

Pulmonary Associates of Richmond, Inc.

Distance

Address:

Richmond, Virginia 23230, United States

获得指引

University of Kansas Medical Center

Distance

Address:

Kansas City, Kansas 66160, United States

获得指引

搜索当地的患者支持团体

用鼠标移动地图，点击红色大头针以搜索您所在地当地的支持团体

跨国支持团体

肺动脉高压联盟

www.allianceforpulmonaryhypertension.com

欧洲肺动脉高压协会

www.phaeurope.org

拉丁美洲肺动脉高压学会

www.sociedadlatinahp.org

全球过敏和呼吸道患者平台

www.gaapp.org

常见问题

PROSERA 研究介绍

什么是临床试验研究？

临床试验是一种旨在探索新治疗方案并且评估其对人类健康结果的影响的研究。

什么是“知情同意”？

知情同意过程将向您提供关于临床试验研究的信息以便您决定是否参与。此过程涉及的活动包括：

  • 报告关于研究的所有细节
  • 总结开展此项研究的原因
  • 自愿做决定

知情同意过程为您提供了一个成为自己的医疗保健决策的知情参与者的机会。您自主（自愿）选择参加一项临床试验研究——在充分知晓此举意味着什么的基础上。您必须阅读并签署《知情同意书》才能参加本项研究。

过去是否曾开展过关于塞拉替尼的研究？结果如何？

2 期 TORREY 研究曾对塞拉替尼展开试验。更多关于 TORREY 研究的详细说明可在此处找到： https://www.gossamerbio.com/pipeline/pipeline-overview/

我需要参加这项研究多长时间？

首先要经过一个为期 4 周的、旨在评估您是否有参与资格的筛选期，然后，本项研究将持续最长 48 周或直至最后一名参与者结束 24 周治疗，最后一剂治疗后 4 周内完成一次随访访视（总共 10-15 次访视）。所有参加完本项研究的人都将被邀请参加 PROSERA-EXT 研究以继续接受/改用塞拉替尼。

在研究期间我是否可以继续使用我当前正在使用的肺动脉高压治疗药？

可以，除研究治疗以外，您还可以使用最多三种药物来帮助您控制肺动脉高压。

我是否会因为参加这项研究而获得报酬？

是。我们将向您免费提供研究药物、设备、检测和程序，报销您为参加本项研究付出的时间和产生的相关费用。

我可能会遭遇什么副作用？

来自 2 期 TORREY 研究参与者的报告称最常见的副作用是轻度至中度咳嗽。这个副作用可能与通过干粉吸入器给药有关。如果您在接受研究药物治疗期间遭遇任何副作用，请尽快报告研究医生。

什么是“安慰剂”？

一种看起来像活性药物，但不含任何有效药物的治疗方案。

如果被分配到安慰剂组，是否可以选择改用研究药物？

治疗期结束时，您将有机会参加 PROSERA-EXT 研究以继续接受塞拉替尼或者（如果您原来接受的是安慰剂）改用塞拉替尼。

隐私、撤药、费用和许可

如果我参加本项研究，你们会如何处理我的个人信息？

您的基本个人信息可能会被记录在您的研究医疗记录中，包括您的姓名、联系方式、性别、身高、体重和种族、您的病史信息以及在您参加研究期间收集到的临床数据。

我们将对您的信息保密，不会在未经您同意的情况下发布任何会暴露您身份的信息，除非应法律要求。

我可以提前退出临床试验吗？

您可以随时改变主意并撤回您的同意，理由不限，您应获得的常规医学治疗不会因此受到影响。

如果您对您的参与资格或 PROSERA 研究仍有疑问，请联系您的医生或专科医生。

共享与本项研究有关的信息

复制并粘贴下方链接以便与朋友或家人共享关于 PROSERA 研究的信息

ClinicalTrials.gov euclinicaltrials.eu