此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases

2026年10月27日 更新者：Boehringer Ingelheim

一项双盲，随机，安慰剂对照试验，评估了26周内Nerandomilast对全身性自身免疫性风湿性疾病相关的间质肺疾病（SARD-ILD）患者的疗效和安全性

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.

Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease.

Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

414

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100730
        • Peking Union Medical College Hospital
      • Beijing、中国、100020
        • Beijing Chao-Yang Hospital
      • Beijing、中国、100029
        • China-Japan Friendship Hospital
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
      • Chengdu、中国、610072
        • Sichuan Provincial People's Hospital
      • Guangzhou、中国、510080
        • Guangdong Provincial People's Hospital
      • Hangzhou、中国、310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou、中国、310003
        • The First Affiliated Hospital, Zhejiang University
      • Luoyang、中国、471000
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Macau、中国、999078
        • University Hospital_Macau University of Science and Technology
      • Nanchang、中国、330006
        • The First Affiliated Hospital of Nanchang University
      • Shanghai、中国、200040
        • Huashan Hospital, Fudan University
      • Tianjin、中国、30052
        • Tianjin Medical University General Hospital
      • Wuhan、中国、430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
      • Wuhan、中国、430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xiamen、中国、361003
        • First Affiliated Hospital of Xiamen University
      • Zhuzhou、中国、412007
        • Zhuzhou Central Hospital
  • 墨西哥
      • Chihuahua City、墨西哥、31020
        • Investigacion y Biomedicina de Chihuahua S.C.
      • Guadalajara、墨西哥、44160
        • Centro Integral en Reumatologia, SA. de CV.
      • Mexico City、墨西哥、14080
        • Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
      • Mexico City、墨西哥、03650
        • Soltmed Smo
      • Mexico City、墨西哥、06700
        • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
      • Monterrey、墨西哥、64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • Mérida、墨西哥、97070
        • Medical Care & Research SA de CV
  • 奥地利
      • Krems、奥地利、3500
        • Krems University Hospital
      • Wels、奥地利、4600
        • Klinikum Wels - Grieskirchen GmbH
  • 德国
      • Berlin、德国、10117
        • Charité - Universitätsmedizin Berlin
      • Berlin、德国、13125
        • Immanuel-Krankenhaus GmbH
      • Bonn、德国、53127
        • Universitätsklinikum Bonn AöR
      • Braunschweig、德国、38126
        • Städtisches Klinikum Braunschweig gGmbH
      • Bremen、德国、28325
        • Gesundheit Nord gGmbH | Klinikverbund Bremen
      • Cologne、德国、51149
        • Krankenhaus Porz am Rhein gGmbH
      • Düsseldorf、德国、40225
        • Universitätsklinikum Düsseldorf
      • Essen、德国、45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Freiburg im Breisgau、德国、79106
        • Universitätsklinikum Freiburg
      • Gommern、德国、39245
        • Helios Fachklinik Vogelsang-Gommern GmbH
      • Hanover、德国、30625
        • Medizinische Hochschule Hannover
      • Herne、德国、44649
        • St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
      • Kirchheim unter Teck、德国、73230
        • medius Kliniken gGmbH
      • Konstanz、德国、78464
        • Klinikum Konstanz
      • Lübeck、德国、23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Minden、德国、32429
        • Johannes Wesling Klinikum Minden
      • München、德国、80336
        • Klinikum der Universität München AÖR
      • Regensburg、德国、93049
        • Krankenhaus Barmherzige Brüder Regensburg
  • 意大利
      • Brescia、意大利、25123
        • ASST degli Spedali Civili di Brescia
      • Florence、意大利、50134
        • A. O. Universitaria Careggi
      • Milan、意大利、20132
        • Ospedale San Raffaele S.r.l.
      • Milan、意大利、20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
      • Padova、意大利、35128
        • Azienda Ospedaliera Universitaria di Padova
      • Pavia、意大利、27100
        • Fondazione IRCCS Policlinico S. Matteo
      • Roma、意大利、00161
        • AOU Policlinico Umberto I
  • 挪威
      • Nordbyhagen、挪威、1478
        • Akershus Universitetssykehus HF
      • Skien、挪威、N-3710
        • Sykehuset Telemark HF, Avd. Skien
  • 日本
      • Aichi, Toyoake、日本、470-1192
        • Fujita Health University Hospital
      • Fukuoka, Kitakyushu、日本、807-8556
        • Hospital of the University of Occupational and Environmental Health
      • Hiroshima, Hiroshima、日本、734-8551
        • Hiroshima University Hospital
      • Hokkaido, Sapporo、日本、060-8543
        • Sapporo Medical University Hospital
      • Hokkaido, Sapporo、日本、060-8648
        • Hokkaido University Hospital
      • Kagawa, Kita-gun、日本、761-0793
        • Kagawa University Hospital
      • Kanagawa, Kawasaki、日本、216-8511
        • St. Marianna University Hospital
      • Kanagawa, Sagamihara、日本、252-0375
        • Kitasato University Hospital
      • Kyoto, Kyoto、日本、606-8507
        • Kyoto University Hospital
      • Nagasaki, Nagasaki、日本、852-8501
        • Nagasaki University Hospital
      • Osaka, Takatsuki、日本、569-8686
        • Osaka Medical and Pharmaceutical University Hospital
      • Saitama, Iruma-gun、日本、350-0495
        • Saitama Medical University Hospital
      • Tokyo, Bunkyo-Ku、日本、113-8431
        • Juntendo University Hospital
      • Tokyo, Bunkyo-ku、日本、113-8603
        • Nippon Medical School Hospital
      • Tokyo, Shinjuku-ku、日本、160-8582
        • Keio University Hospital
  • 法国
      • Angers、法国、49933
        • HOP d'Angers
      • Bordeaux、法国、33076
        • HOP Pellegrin
      • Lille、法国、59037
        • Hôpital Claude Huriez
      • Paris、法国、75014
        • Hôpital Cochin
      • Paris、法国、75018
        • HOP Bichat
      • Rennes、法国、35203
        • HOP Sud
      • Strasbourg、法国、67091
        • HOP Civil
      • Toulouse、法国、31059
        • Hôpital Rangueil - CHU de Toulouse
  • 波多黎各
      • San Juan、波多黎各、00917
        • GCM Medical Group, PSC
  • 澳大利亚
    • New South Wales
      • Camperdown, Sydney、New South Wales、澳大利亚、2050
        • Royal Prince Alfred Hospital
      • Darlinghurst、New South Wales、澳大利亚、2010
        • St Vincent's Hospital Sydney
    • Queensland
      • Chermside、Queensland、澳大利亚、4032
        • The Prince Charles Hospital
    • Victoria
      • Heidelberg、Victoria、澳大利亚、3084
        • Austin Hospital
    • Western Australia
      • Murdoch、Western Australia、澳大利亚、6150
        • Fiona Stanley Hospital
  • 瑞士
      • Aarau、瑞士、CH-5001
        • Cantonal Hospital of Aarau
      • Basel、瑞士、4031
        • Universitätsspital Basel
      • Geneva、瑞士、1205
        • Hopitaux Universitaires de Geneve (HUG)
      • Neuchâtel、瑞士、2000
        • Neuchatel Hospital Network
      • Sankt Gallen、瑞士、9007
        • Kantonsspital St.Gallen
      • Zurich、瑞士、8091
        • University Hospital Zurich
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale、Arizona、美国、85259
        • Mayo Clinic-Arizona
    • California
      • Los Angeles、California、美国、90095
        • University of California Los Angeles
      • San Diego、California、美国、92108
        • Paradigm Clinical Research - San Diego
    • Colorado
      • Denver、Colorado、美国、80206
        • National Jewish Health
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University School of Medicine
    • Florida
      • Brandon、Florida、美国、33511
        • Meris Clinical Research-Brandon-69466
      • Miami、Florida、美国、33125
        • Miami VA Healthcare System
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
      • Augusta、Georgia、美国、30912
        • Augusta University
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
      • Chicago、Illinois、美国、60637
        • The University of Chicago Medical Center
      • Evanston、Illinois、美国、60201
        • Northshore University Health System
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
      • Rochester、Minnesota、美国、55902
        • Mayo Clinic, Rochester
    • Nebraska
      • Omaha、Nebraska、美国、68198-1230
        • University of Nebraska Medical Center
    • New York
      • Great Neck、New York、美国、11021
        • Northwell Health
      • New York、New York、美国、10017
        • NYU Langone Health
      • New York、New York、美国、10032
        • New York Presbyterian Hospital -Columbia University
    • North Carolina
      • Salisbury、North Carolina、美国、28144
        • Onsite Clinical Solutions
      • Winston-Salem、North Carolina、美国、27103
        • Southeastern Research Center-Winston Salem-69289
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • Temple Lung Center
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston、Texas、美国、77030
        • The University of Texas Health Science Center at Houston
      • San Antonio、Texas、美国、78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City、Utah、美国、84108
        • University of Utah Health Sciences Center
    • West Virginia
      • Beckley、West Virginia、美国、25801
        • Rheumatology and Pulmonary Clinic
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • University of Wisconsin
  • 英国
      • Antrim、英国、BT41 2RL
        • Antrim Area Hospital
      • Bath、英国、BA1 3NG
        • Royal United Hospital, Bath
      • Birmingham、英国、B9 5SS
        • Heartlands Hospital
      • Leeds、英国、LS7 4SA
        • Chapel Allerton Hospital
      • London、英国、NW3 2QG
        • Royal Free Hospital
      • London、英国、SW17 0QT
        • St George's Hospital
      • London、英国、WC1E 6BT
        • University College Hospital
      • Londonderry、英国、BT47 6SB
        • Altnagelvin Area Hospital
      • Luton、英国、LU4 8RB
        • Luton & Dunstable University Hospital
      • Preston、英国、PR2 9HT
        • NIHR Lancashire Clinical Research Facility
      • Sheffield、英国、S5 7AU
        • Northern General Hospital
      • Truro、英国、TR1 3LJ
        • Royal Cornwall Hospital
      • Westcliffe-on-Sea、英国、SS0 0RY
        • Southend University Hospital
  • 荷兰
      • Heerlen、荷兰、6419 PC
        • Zuyderland Medisch Centrum
      • Nieuwegein、荷兰、3435 CM
        • St. Antonius Ziekenhuis
      • Rotterdam、荷兰、3015
        • Erasmus Medisch Centrum-ROTTERDAM-50697
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona、西班牙、08026
        • Hospital Santa Creu i Sant Pau
      • Bilbao、西班牙、48013
        • Hospital de Basurto
      • Córdoba、西班牙、14004
        • Hospital Universitario Reina Sofía
      • Huelva、西班牙、21005
        • Hospital Juan Ramón Jimenez
      • L'Hospitalet de Llobregat、西班牙、08907
        • Hospital Universitari de Bellvitge
      • Madrid、西班牙、28040
        • Fundación Jiménez Díaz
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28034
        • Hospital Universitario Ramon Y Cajal
      • Santiago de Compostela、西班牙、15706
        • Hospital Clínico de Santiago
      • Seville、西班牙、41009
        • Hospital Universitario Virgen De La Macarena
      • Seville、西班牙、41013
        • Hospital Virgen del Rocio
      • Valencia、西班牙、46017
        • Hospital Dr. Peset
      • Vigo、西班牙、36312
        • Complejo Hospitalario Universitario de Vigo
  • 韩国
      • Seongnam、韩国、13620
        • Seoul National University Bundang Hospital
      • Seoul、韩国、03080
        • Seoul National University Hospital
      • Seoul、韩国、04401
        • Soonchunhyang University Hospital Seoul
      • Seoul、韩国、02447
        • Kyung Hee University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as

    • Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
    • Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent >10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review

  • No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:

    • No improvement in absolute forced vital capacity (FVC) % predicted >5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted >5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
    • No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)

  • FVC ≥45% of predicted normal at Visit 1

  • Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1

  • Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:

    • If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
    • If using rituximab, participants must have completed their first cycle >6 months prior to Visit 2

  • If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2

  • In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned

  • Further inclusion criteria apply

Exclusion Criteria:

  • Organising pneumonia as predominant pattern in the HRCT
  • Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1
  • Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
  • Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
  • Any suicidal behaviour in the past 2 years
  • Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
  • Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
  • Further exclusion criteria apply

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Nerandomilast

Participants with SARD-ILDs will receive nerandomilast.
药品：Nerandomilast

Nerandomilast

其他名称：
  • 杰斯凯德®
安慰剂比较：Placebo

Participants with SARD-ILDs will receive placebo.
药品：Placebo matching nerandomilast

Placebo matching nerandomilast

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
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
大体时间：At baseline and at Week 26

QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC.

Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD [%] is the QILD volume [mL] as a percent of the total lung volume.

A higher QILD percentage or volume indicates a higher extent of disease.
At baseline and at Week 26

次要结果测量

结果测量
措施说明
大体时间
第26周HRCT的血管体积基线的绝对变化[％]
大体时间：基线和第26周
基线和第26周
在基线的整个试验中，整个试验中补充氧气中的基线的绝对变化
大体时间：基线和第52周
基线和第52周
试验期间首次补充氧气在基线时使用氧气
大体时间：直到第52周
直到第52周
在试验期间，基线的与感染相关的不良事件（AES）的发生
大体时间：最多1年
最多1年
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
大体时间：At baseline and at Week 26

QLF will be assessed via qHRCT. QLF are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion.

Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD [%] is the QILD volume [mL] as a percent of the total lung volume.

A higher QILD percentage or volume indicates a higher extent of disease.
At baseline and at Week 26
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
大体时间：At baseline and at Week 26

QGGO will be assessed via qHRCT. QGGO are quantitative measures of different radiological patterns associated with lung fibrosis. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung.

Quantification of HRCT scans will be performed centrally via a machine learning algorithm.

A higher QGGO percentage or volume indicates a higher extent of disease.
At baseline and at Week 26
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
大体时间：At baseline and at Week 26

FVC will be assessed using standardised spirometry equipment which will be provided centrally with supplies of precalibrated disposable flow sensors. Spirometry will be conducted with the participant in a seated position. It is preferable that the same trained individual (i.e. PFT specialist or pulmonologist) performs the PFTs for a given participant. The best of 3 efforts will be defined as the highest FVC obtained on any of three blows meeting the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (with a maximum of eight attempts). Predicted normal values will be calculated according to global lung function initiative (GLI).
At baseline and at Week 26

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月13日

初级完成 (估计的)

2027年4月15日

研究完成 (估计的)

2027年4月28日

研究注册日期

首次提交

2025年1月28日

首先提交符合 QC 标准的

2025年1月28日

首次发布 (实际的)

2025年2月4日

研究记录更新

最后更新发布 (实际的)

2026年10月28日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1305-0046
  • U1111-1305-5857 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))
  • 2024-512849-17-00 (注册表标识符：CTIS (EU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Once the criteria in section "time frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents -upon signing of a "Document Sharing Agreement". For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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.

订阅