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Pevonedistat 和 Venetoclax 联合阿扎胞苷治疗无法接受强化化疗的成人急性髓性白血病 (AML) 的研究 (PEVENAZA)

2026年8月26日 更新者：Takeda

Pevonedistat、Venetoclax 和阿扎胞苷对比 Venetoclax 加阿扎胞苷治疗不适合强化化疗的新诊断急性髓性白血病成人的随机、开放标签、对照 2 期研究

The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.

Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin).

Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: Pevonedistat + Venetoclax + Azacitidine combination arm group when compared with Arm B: Venetoclax + Azacitidine.

The study will enroll approximately 164 participants. Participants will be randomly assigned in 1:1 ratio to one of the two treatment groups in 28-day treatment cycles and which will remain disclosed to the participant and study doctor during the study:

  • Pevonedistat 20 mg/m^2 + Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400mg) + Azacitidine 75 mg/m^2
  • Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400 mg) + Azacitidine 75 mg/m^2

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner.

研究类型

介入性

注册 (实际的)

164

阶段

  • 阶段2

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton、Alberta、加拿大、T6G 2G3
        • University of Alberta
    • Ontario
      • London、Ontario、加拿大、N6A 5W9
        • London Health Sciences Centre
      • Ottawa、Ontario、加拿大、K1H 8L6
        • Ottawa Hospital
    • Quebec
      • Québec、Quebec、加拿大、G1J 1Z4
        • Hopital de L'enfant Jesus
  • 意大利
      • Bologna、意大利、40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Florence、意大利、50134
        • Azienda Ospedaliera Universitaria Careggi
      • Pavia、意大利、27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Calabria
      • Reggio Calabria、Calabria、意大利、89133
        • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
    • Lombardy
      • Monza、Lombardy、意大利、20900
        • ASST di Monza - Azienda Ospedaliera San Gerardo
    • Milano
      • Rozzano、Milano、意大利、20089
        • Istituto Clinico Humanitas
    • Piedmont
      • Orbassano、Piedmont、意大利、10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
      • Turin、Piedmont、意大利、10126
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
    • Umbria
      • Perugia、Umbria、意大利、06156
        • Ospedale Santa Maria Della Misericordia Di Perugia
  • 法国
      • Bobigny、法国、93009
        • Hopital Avicenne
      • Caen、法国、14033
        • Institut dHematologie de Basse Normandie
      • Grenoble、法国、38043
        • CHU de Grenoble
      • Lille、法国、59037
        • CHRU Lille
      • Nantes、法国、44093
        • CHRU Nantes
      • Nice、法国、06202
        • CHU de Nice
      • Paris、法国、75012
        • Hopital Saint Antoine
      • Paris、法国、75475
        • Hopital Saint Louis
      • Pierre-Bénite、法国、69495
        • Centre Hospitalier Lyon Sud
      • Poitiers、法国、86021
        • CHRU de Poitiers La Miletrie
      • Toulouse、法国、31059
        • EDOG - Institut Claudius Regaud - PPDS
    • Sarthe
      • Le Mans、Sarthe、法国、72000
        • Centre Hospitalier Le Mans
  • 波兰
      • Bydgoszcz、波兰、85-168
        • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
      • Gdansk、波兰、80-952
        • Uniwersyteckie Centrum Kliniczne
      • Lublin、波兰、20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、31-501
        • Szpital Uniwersytecki w Krakowie
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、02-776
        • Instytut Hematologii i Transfuzjologii
      • Warsaw、Masovian Voivodeship、波兰、02-106
        • MTZ Clinical Research Sp z o o
    • Podlaskie Voivodeship
      • Bialystok、Podlaskie Voivodeship、波兰、15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Banner MD Anderson Cancer Center
    • California
      • La Jolla、California、美国、92093
        • UC San Diego Moores Cancer Center
      • Orange、California、美国、92868
        • UC Irvine Medical Center
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami Miller School of Medicine
      • Orlando、Florida、美国、32804
        • AdventHealth (Florida Hospital) - Transplant Institute
    • Kentucky
      • Louisville、Kentucky、美国、40207
        • Norton Cancer Institute - Suburban
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • Missouri
      • Kansas City、Missouri、美国、64132
        • HCA Midwest Health - SCRI - PPDS
    • New York
      • Lake Success、New York、美国、11042
        • Northwell Health Cancer Institute
      • New York、New York、美国、10029-6574
        • Icahn School of Medicine at Mount Sinai
      • Stony Brook、New York、美国、11794
        • Stony Brook Medicine
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514-4221
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland、Ohio、美国、44106
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • The University of Oklahoma Health Sciences Center
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • Avera Cancer Institute
    • Texas
      • Houston、Texas、美国、77030
        • Houston Methodist Cancer Center
      • Lubbock、Texas、美国、79410
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Salt Lake City、Utah、美国、84143
        • Intermountain LDS Hospital
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia Health System
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • West Virginia University Hospital
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin

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:

  • Has morphologically confirmed diagnosis of AML (World Health Organization [WHO] criteria 2008). Participants may have newly diagnosed primary de novo AML or secondary AML (sAML), defined as AML after myelodysplastic syndromes (MDS) or myeloproliferative neoplasm (MPN), or therapy-related AML (t-AML) following cytotoxic therapy, and/or radiotherapy for a malignant or nonmalignant disease.

  • Is unfit for treatment with a standard arabinosylcytosine (Ara-C) and anthracycline induction regimen due to age or co-morbidities defined by 1 of the following:

    • ≥75 years of age. OR
    • ≥18 to <75 years of age with at least one of the following:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.

  • Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).

  • Severe pulmonary disorder (e.g., carbon monoxide lung diffusion capacity ≤65% or forced expiratory volume in 1 second ≤65%).

  • Creatinine clearance (CrCl) <45 mL/min (but ≥30 mL/min as part of general eligibility criteria).

  • Hepatic disorder with total bilirubin >1.5 times the upper limit of the normal range (ULN).

  • Has clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):

    • Total bilirubin ≤1.5 times the ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll with direct bilirubin ≤3 times the ULN of the direct bilirubin. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times the ULN.
    • Creatinine clearance (CrCl) ≥30 mL/min (calculated by the Modification of Diet in Renal Disease [MDRD] Study equation).
    • Albumin >2.7 g/dL.

  • White blood cell (WBC) count <25 × 10^9/L. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria before starting therapy.

Exclusion Criteria:

  • Has history of MPN with BCR-ABL1 translocation or AML with BCR-ABL1 translocation.

  • Has genetic diagnosis of acute promyelocytic leukemia.

  • Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation.

  • Has extramedullary AML without evidence of bone marrow involvement.

  • Had prior treatment with hypomethylating agents for AML (hypomethylating agent treatment for prior MDS is not exclusionary).

  • Has clinical evidence of or history of central nervous system involvement by AML.

  • Had diagnosed or treated for another malignancy (except for adequately treated carcinoma in situ of any organ or nonmelanoma skin cancer) within 1 year before randomization or previously diagnosed with another malignancy and have any evidence of residual disease that may compromise the administration of pevonedistat, venetoclax or azacitidine. Prior MDS is also allowed, but the participant cannot have received treatment for MDS within 14 days before first dose of any study drug.

  • Has a WBC count ≥25 × 10^9/L

  • Has uncontrolled human immunodeficiency virus (HIV) infection. Note: Known HIV positive participants who meet the following criteria will be considered eligible:

    • Cluster difference 4 (CD4) count >350 cells/mm^3.
    • Undetectable viral load.
    • Maintained on modern therapeutic regimens utilizing non-cytochrome P (CYP)-interactive agents.
    • No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections.

  • Participant is known to be positive for hepatitis B or C infection, with the exception of those with an undetectable viral load within 3 months (hepatitis B or C testing is not required for eligibility assessment).

  • Has hepatic cirrhosis.

  • Has uncontrolled coagulopathy or bleeding disorder.

  • Has high blood pressure which cannot be controlled by standard treatments.

  • Has prolonged rate QTc interval ≥500 msec, calculated according to institutional guidelines.

  • Has left ventricular ejection fraction (LVEF) <40%, based on echocardiogram or multi gated acquisition (MUGA) scan at screening (data to be available within last 3 months of screening).

  • As infection is a common feature of AML, participants with active infection are permitted to enroll provided that the infection is under control and no signs of systemic inflammatory response beyond low grade fever that makes participant clinically unstable in the opinion of the investigator. Participants with uncontrolled infection shall not be enrolled until infection is treated and brought under control.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Venetoclax + Azacitidine

Participants received venetoclax 100 milligram (mg) tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Days 3 through 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Days 1 through 21 or 28 as per Investigator's discretion. In addition, participants received azacitidine 75 milligrams per square meter (mg/m^2) intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, 8, and 9 in each cycle.
药品：Venetoclax

Venetoclax tablets.

药品：Azacitidine

Azacitidine IV or SC injection.
实验性的：Pevonedistat + Venetoclax + Azacitidine

Participants received pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle. In addition participants received venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Days 3 through 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion. Participants also received azacitidine 75 mg/m^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, 8, and 9 in each cycle.
药品：Venetoclax

Venetoclax tablets.

药品：Azacitidine

Azacitidine IV or SC injection.

药品：Pevonedistat

Pevonedistat IV infusion.

其他名称：
  • MLN4924
  • TAK-924

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
Event-Free Survival (EFS)
大体时间：Up to 22 months

EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts <5 percent (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than or equal to (≥) 1.0×10^9 per liter (10^9/L) (1000/microliter [µL]); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). For participants who achieved CR/CRi, if relapse was not observed by time of analysis, data was censored at the date of last disease assessment. If failed to achieve CR/CRi, date of treatment failure was set on day of randomization.
Up to 22 months

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to 36 months

OS was defined as the time from randomization to death from any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. OS was analyzed using the Kaplan-Meier method.
Up to 36 months
30-Day Mortality Rate
大体时间：Day 30

30-day mortality rate was defined as the percentage of participants who survived at most 30 days from the first dose of study drug.
Day 30
60-Day Mortality Rate
大体时间：Day 60

60-day mortality rate was defined as the percentage of participants who survived at most 60 days from the first dose of study drug.
Day 60
Percentage of Participants With Complete Remission (CR)
大体时间：Up to 36 months

CR rate was defined as the percentage of participants who achieved the CR as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL).
Up to 36 months
Percentage of Participants With Composite Complete Remission (CCR)
大体时间：Up to 36 months

CCR rate was defined as the percentage of participants who achieved the CR + CRi as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]).
Up to 36 months
Overall Response Rate (ORR)
大体时间：Up to 36 months

ORR was defined as the percentage of participants who achieved the CR + CRi + Partial Remission (PR) as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Up to 36 months
Percentage of Participants With CR + CRh
大体时间：Up to 36 months

CR + CRh rate was defined as the percentage of participants who achieved the CR + CRh as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRh was defined as bone marrow with <5% blasts, peripheral blood neutrophil count >0.5×10^3/µL and peripheral blood platelet count >0.5×10^5/µL.
Up to 36 months
Percentage of Participants With Leukemia Response
大体时间：Up to 36 months

Leukemia response rate was defined as the percentage of participants who achieved the CR + CRi + PR + morphological leukemia-free state [MLFS, marrow CR (mCR)]) as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. MLFS is defined as bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
Up to 36 months
Duration of CR and CRi
大体时间：Up to 36 months

Duration of CR and CRi was defined as the time from first documentation of CR or CRi to the date of first documentation of progressive disease (PD) or relapse from CR or CRi, and was summarized descriptively using the Kaplan Meier method based on the responders. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]).
Up to 36 months
Time to First CR, CRi and PR
大体时间：Up to 36 months

Time to first CR, CRi, and PR was defined as the time from randomization until the first documented CR, CRi or PR, whichever occurs first. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Up to 36 months
Plasma Concentration of Pevonedistat
大体时间：At multiple time points pre-dose and post-dose on Days 1, 3 and 5 in Cycle 1 and post-dose on Day 1 in Cycles 2 and 4 (cycle length= 28 days)

As pre-specified in the protocol, plasma concentration-time data were planned to contribute to future pharmacokinetic (PK) population and exposure response (safety/efficacy) analyses of pevonedistat.
At multiple time points pre-dose and post-dose on Days 1, 3 and 5 in Cycle 1 and post-dose on Day 1 in Cycles 2 and 4 (cycle length= 28 days)

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

Takeda

调查人员

  • 研究主任：Medical Director、Takeda

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。

一般刊物

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)

2020年10月13日

初级完成 (实际的)

2022年9月6日

研究完成 (实际的)

2025年10月6日

研究注册日期

首次提交

2020年2月4日

首先提交符合 QC 标准的

2020年2月11日

首次发布 (实际的)

2020年2月12日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Pevonedistat-2002
  • 2019-003117-33 (EudraCT编号)
  • U1111-1239-7581 (注册表标识符：WHO)
  • 2019 (美国 NIH 拨款/合同)
  • 2024-515424-36-00 (克蒂斯)

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

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD 共享访问标准

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 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.

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