JNJ-81201887 (AAVCAGsCD59) 家长研究的长期扩展研究，对象为继发于年龄相关性黄斑变性 (AMD) 的地理萎缩 (GA)
JNJ-81201887 家长临床研究中继发于年龄相关性黄斑变性 (AMD) 的地理萎缩 (GA) 参与者的长期扩展研究
The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Study Contact
- 电话号码：844-434-4210
- 邮箱：Participate-In-This-Study1@its.jnj.com
学习地点
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Beijing、中国、100730
- 招聘中
- Beijing Tongren Hospital CMU
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Chengdu、中国、610041
- 招聘中
- West China Hospital Si Chuan University
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Shanghai、中国、200080
- 招聘中
- Shanghai General Hospital
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Glostrup Municipality、丹麦、2600
- 主动，不招人
- University Hospital Of Copenhagen, Glostrup Hospital
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-
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Alberta
-
Edmonton、Alberta、加拿大、T5H 0X5
- 完全的
- Alberta Retina Consultants
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-
-
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Budapest、匈牙利、1062
- 招聘中
- Eszak Pesti Centrumkorhaz Honvedkorhaz
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Pécs、匈牙利、7621
- 招聘中
- Ganglion Orvosi Központ
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Zalaegerszeg、匈牙利、8900
- 招聘中
- Zala Varmegyei Szent Rafael Korhaz
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-
-
-
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Ankara、土耳其（türkiye）、06230
- 招聘中
- Hacettepe University Medical Faculty
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Ankara、土耳其（türkiye）、06490
- 招聘中
- Baskent University Ankara Hospital
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Izmir、土耳其（türkiye）、35330
- 招聘中
- Dokuz Eylul University Medical Faculty
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-
-
-
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Bonn、德国、53127
- 招聘中
- Universitaets-Augenklinik Bonn
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Göttingen、德国、37075
- 招聘中
- Klinikum Gottingen der Georg August Universitat
-
Hanover、德国、30625
- 招聘中
- Medizinische Hochschule Hannover
-
Leipzig、德国、04103
- 招聘中
- Universitaetsklinikum Leipzig
-
Ludwigshafen am Rhein、德国、67063
- 招聘中
- Klinikum Ludwigshafen
-
Münster、德国、48145
- 招聘中
- Augenzentrum am St Franziskus Hospital Munster
-
Tübingen、德国、72076
- 招聘中
- Universitaetsklinikum Tuebingen
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-
-
-
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Ferrara、意大利、44124
- 招聘中
- Azienda Ospedaliero Universitaria di Ferrara
-
Milan、意大利、20157
- 招聘中
- ASST Fatebenefratelli Sacco
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Milan、意大利、20122
- 招聘中
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Milan、意大利、20132
- 招聘中
- IRCCS Ospedale San Raffaele
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Naples、意大利、80138
- 招聘中
- Azienda Ospedaliero Universitaria Luigi Vanvitelli
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Roma、意大利、00168
- 招聘中
- Fondazione Policlinico Universitario A Gemelli IRCCS
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-
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Prague、捷克语、15000
- 主动，不招人
- AXON Clinical s.r.o.
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Prague、捷克语、100 34
- 主动，不招人
- Fakultni nemocnice Kralovske Vinohrady
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-
-
-
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Genk、比利时、3600
- 主动，不招人
- Ziekenhuis Oost-Limburg
-
Ghent、比利时、9000
- 主动，不招人
- UZ Gent
-
Leuven、比利时、3000
- 主动，不招人
- UZ Leuven Gasthuisberg
-
-
-
-
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Bydgoszcz、波兰、85 631
- 主动，不招人
- Oftalmika
-
Warsaw、波兰、01 258
- 主动，不招人
- Warszawski Szpital Okulistyczny
-
-
-
-
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East Melbourne、澳大利亚、3002
- 招聘中
- Centre for Eye Research Australia
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Strathfield、澳大利亚、2135
- 招聘中
- Strathfield Retina Clinic
-
Sydney、澳大利亚、2000
- 招聘中
- Sydney Retina Clinic and Day Surgery
-
Westmead、澳大利亚、2145
- 招聘中
- Sydney West Retina
-
-
-
-
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Stockholm、瑞典、171 64
- 主动，不招人
- S:t Eriks Ogonsjukhus
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-
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-
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Bern、瑞士、3010
- 招聘中
- Inselspital Universitatsspital Bern
-
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-
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Arizona
-
Tucson、Arizona、美国、85704
- 招聘中
- Retina Associates Southwest PC
-
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California
-
Fullerton、California、美国、92835
- 招聘中
- Retina Consultants of Orange County
-
La Jolla、California、美国、92093 0946
- 招聘中
- Shiley Eye Institute Jacobs Retina Center
-
Oxnard、California、美国、93036
- 招聘中
- California Retina Consultants
-
Pasadena、California、美国、91107
- 招聘中
- California Eye Medical Specialists
-
Poway、California、美国、92064
- 招聘中
- Retina Consultants San Diego
-
Walnut Creek、California、美国、94598
- 招聘中
- Bay Area Retina Associates
-
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Florida
-
Fort Lauderdale、Florida、美国、33308
- 招聘中
- Retina Group of Florida
-
Gainesville、Florida、美国、32607
- 招聘中
- VitreoRetinal Associates, PA
-
Pensacola、Florida、美国、32503
- 招聘中
- Retina Specialty Institute
-
St. Petersburg、Florida、美国、33711
- 招聘中
- Retina Vitreous Associates of Florida
-
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Georgia
-
Marietta、Georgia、美国、30060
- 招聘中
- Georgia Retina
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Marietta、Georgia、美国、30060
- 招聘中
- Marietta Eye Clinic
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Illinois
-
Lemont、Illinois、美国、60439
- 招聘中
- University Retina
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Indiana
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Carmel、Indiana、美国、46032
- 招聘中
- Midwest Eye Institute
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Maine
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Portland、Maine、美国、04101
- 招聘中
- Maine Eye Center
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Maryland
-
Baltimore、Maryland、美国、21204
- 招聘中
- Retina Specialists
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Chevy Chase、Maryland、美国、20815
- 招聘中
- The Retina Group of Washington
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Hagerstown、Maryland、美国、21740
- 招聘中
- Cumberland Valley Retina Consultants
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Ophthalmic Consultants of Boston
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Michigan
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Grand Rapids、Michigan、美国、49546
- 招聘中
- Foundation for Vision Research
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Minnesota
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Saint Louis Park、Minnesota、美国、55416
- 招聘中
- Retina Consultants of Minnesota
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Missouri
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St Louis、Missouri、美国、63128
- 招聘中
- The Retina Institute
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Nevada
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Reno、Nevada、美国、89502
- 招聘中
- Sierra Eye Associates
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New York
-
Liverpool、New York、美国、13088
- 招聘中
- Retina-Vitreous Surgeons of Central New York
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North Carolina
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Asheville、North Carolina、美国、28803
- 招聘中
- Asheville Eye Associates - Western Carolina Retinal Associates
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Durham、North Carolina、美国、27705
- 招聘中
- Duke Eye Center
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Hickory、North Carolina、美国、28602
- 招聘中
- Graystone Eye
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Wake Forest、North Carolina、美国、27587
- 招聘中
- NC Retina Associates
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Ohio
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Cincinnati、Ohio、美国、45242
- 招聘中
- Cincinnati Eye Institute
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Cleveland、Ohio、美国、44195
- 招聘中
- Cleveland Clinic Main Campus
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Oregon
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Eugene、Oregon、美国、97401
- 招聘中
- Verum Research LLC
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Springfield、Oregon、美国、97477
- 招聘中
- Cascade Medical Research Institute, LLC
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Pennsylvania
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Erie、Pennsylvania、美国、16505
- 招聘中
- Erie Retina Research
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South Carolina
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Beaufort、South Carolina、美国、29902
- 招聘中
- Charleston Neuroscience Institute, LLC
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Texas
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Austin、Texas、美国、78750
- 招聘中
- Austin Clinical Research
-
Dallas、Texas、美国、75390
- 招聘中
- UT Southwestern Medical Center
-
Dallas、Texas、美国、75231
- 招聘中
- Texas Retina Associates
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San Antonio、Texas、美国、78240
- 招聘中
- Retina Associates Of South Texas P A
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The Woodlands、Texas、美国、77384
- 招聘中
- Retina Consultants of Texas
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Willow Park、Texas、美国、76087
- 招聘中
- Strategic Clinical Research Group
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Utah
-
Salt Lake City、Utah、美国、84132
- 招聘中
- University of Utah
-
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Virginia
-
Lynchburg、Virginia、美国、24502
- 招聘中
- Piedmont Eye Center
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Norfolk、Virginia、美国、23502
- 招聘中
- Wagner Kapoor Research institute
-
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Washington
-
Spokane、Washington、美国、99204
- 招聘中
- Spokane Eye Clinical Research
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-
-
-
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Bristol、英国、BS1 2LX
- 主动，不招人
- Bristol Eye Hospital
-
Headington、英国、OX3 9DU
- 主动，不招人
- Oxford Eye Hospital
-
London、英国、W1G 9AX
- 主动，不招人
- The Retina Clinic London
-
Newcastle upon Tyne、英国、NE1 4LP
- 完全的
- Royal Victoria Infirmary
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-
-
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Nijmegen、荷兰、6525 GA
- 主动，不招人
- Radboudumc
-
Rotterdam、荷兰、3011
- 主动，不招人
- Het Oogziekenhuis Rotterdam
-
-
-
-
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Coimbra、葡萄牙、3000 075
- 主动，不招人
- Uls Coimbra - Hosp. Univ. Coimbra
-
Coimbra、葡萄牙、3030 163
- 主动，不招人
- Espaco Medico de Coimbra
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Porto、葡萄牙、4200 319
- 主动，不招人
- Uls Sao Joao
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-
-
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Barcelona、西班牙、08021
- 招聘中
- Centro de Oftalmologia Barraquer
-
Barcelona、西班牙、08022
- 招聘中
- Centro Medico Teknon S.L.
-
Barcelona、西班牙、08022
- 招聘中
- Inst. Cat. de Retina
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Burjassot、西班牙、46100
- 招聘中
- Clinica Oftalvist Valencia
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Córdoba、西班牙、14012
- 招聘中
- Hosp. La Arruzafa
-
Madrid、西班牙、28041
- 招聘中
- Hosp. Univ. 12 de Octubre
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Madrid、西班牙、28046
- 招聘中
- Clinica Baviera Madrid Castellana
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Madrid、西班牙、28040
- 招聘中
- Hosp Univ Fund Jimenez Diaz
-
Majadahonda、西班牙、28222
- 招聘中
- Hosp. Univ. Pta. de Hierro Majadahonda
-
Pamplona、西班牙、31008
- 招聘中
- Clinica Univ. de Navarra
-
Sant Cugat del Vallès、西班牙、08195
- 招聘中
- Idc Salud Hosp. Gral. de Catalunya
-
Seville、西班牙、41013
- 招聘中
- Hosp. Virgen Del Rocio
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Zaragoza、西班牙、50009
- 招聘中
- Hosp. Clinico Univ. Lozano Blesa
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)
- Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study
- Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations
Exclusion Criteria:
- There are no exclusion criteria for this LTE study
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm A: JNJ-81201887 Low Dose
Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 [NCT05811351]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study. |
No study intervention will be administered as part of this LTE study. |
|
实验性的：Arm B: JNJ-81201887 High dose
Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 [NCT05811351]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study. |
No study intervention will be administered as part of this LTE study. |
|
假比较器：Arm C: Sham Procedure
Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study. |
No study intervention will be administered as part of this LTE study. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs)
大体时间：Upto 5 Years
|
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention. |
Upto 5 Years
|
|
Number of Participants with Abnormal Findings in Clinical Laboratory Assessments
大体时间：Upto 5 Years
|
Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported. |
Upto 5 Years
|
|
Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations
大体时间：Upto 5 Years
|
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported. |
Upto 5 Years
|
|
Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
大体时间：Baseline up to 42 months
|
BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa. |
Baseline up to 42 months
|
合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 81201887MDG3002
- 2022-500747-21-00 (注册表标识符：EUCT number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.