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使用 MATE 评分的他克莫司/依维莫司与他克莫司/MMF 在小儿心脏移植受者中的比较 (TEAMMATE)

2026年7月7日 更新者：Kevin Daly、Boston Children's Hospital

III 期多中心开放标签随机临床试验比较依维莫司和低剂量他克莫司与他克莫司和吗替麦考酚酯在移植后 6 个月预防小儿心脏移植后的长期并发症

TEAMMATE 试验将在移植后 6 个月招募来自 25 个中心的 210 名儿童心脏移植患者，并对每位患者进行 2.5 年的随访。 一半的参与者将接受依维莫司和低剂量他克莫司，另一半将接受他克莫司和霉酚酸酯。 该试验将确定哪种治疗能更好地降低冠状动脉血管病变、慢性肾病和活检证实的急性细胞排斥反应的累积风险，而不会增加由于所有原因（例如，肾移植）引起的移植物丢失。 感染、PTLD、抗体介导的排斥反应）。

研究概览

地位

完全的

条件

干预/治疗

详细说明

在当今时代，儿科心脏移植 (HT) 后的中位生存期为 15 年。 这意味着，由于与心脏移植相关的并发症，很大一部分在儿童时期接受移植手术的患者无法存活到成年，或需要进行心脏再移植。 这些并发症包括心脏移植排斥反应、感染、冠状动脉疾病、移植后淋巴组织增生性疾病（PTLD；一种在移植受者中出现的淋巴瘤）和肾衰竭。 大多数并发症并非源于心脏移植本身，而是源于通常用于抑制免疫系统以防止排斥反应的药物。 在美国，他克莫司 (TAC) 和吗替麦考酚酯 (MMF) 在过去十年中已成为小儿心脏移植免疫抑制的护理标准。 虽然在 TAC 和 MMF 时代儿科生存率显着提高，但 HT 后并发症仍然是将中位生存期限制在 15 年的主要问题。 最近，依维莫司 (EVL) 已成为一种潜在的替代免疫抑制剂，当与低剂量他克莫司 (LDTAC) 联合给药时，它可以比 TAC/MMF 更有效地预防排斥反应、冠状动脉疾病和肾衰竭。 初步研究表明，EVL 及其第一代类似物西罗莫司在 HT 后的儿童中具有良好的耐受性，无论它是针对冠状动脉疾病、慢性肾病或移植后 4-6 个月的经验开始的努力防止这些并发症的发生1。 然而，研究通常仅限于使用历史对照的单中心经验，并且没有足够的统计功效来证明治疗差异。 这将是第一个在儿科心脏移植中维持免疫抑制的多中心随机临床试验，以系统地评估 EVL 与 LDTAC 与 TAC/MMF 的安全性和有效性，以防止导致死亡/移植物丢失的长期并发症。 主要不良移植事件（MATE）评分将作为推动试验的主要终点。 由于目前没有食品和药物管理局 (FDA) 批准的用于心脏移植后儿童的免疫抑制剂（所有处方都是标签外的）并且支持试验的市场激励措施有限，研究人员通过 2016 财年同行评审为试验提供资金由国会指导的医学研究计划国防部办公室赞助的医学研究计划临床试验奖。 值得注意的是，与成人相比，如果可以最大限度地减少移植后并发症，儿童的潜在预期寿命会大大延长，这使得预防晚期并发症成为儿科心脏移植社区的当务之急。

研究类型

介入性

注册 (实际的)

211

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

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • Children's of Alabama
    • Arizona
      • Phoenix、Arizona、美国、85016
        • Phoenix Children's Hospital
    • California
      • Loma Linda、California、美国、92354
        • Loma Linda University
      • Los Angeles、California、美国、90027
        • Children's Hospital Los Angeles
      • Los Angeles、California、美国、90095
        • UCLA Mattel Children's Hospital
      • Palo Alto、California、美国、94304
        • Stanford University
    • Colorado
      • Aurora、Colorado、美国、80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • Children's National Medical Center
    • Florida
      • Gainesville、Florida、美国、32610-0297
        • University of Florida Congenital Heart Center
      • Hollywood、Florida、美国、33021
        • Joe DiMaggio Children's Hospital
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Children's Healthcare of Atlanta Emory
    • Illinois
      • Chicago、Illinois、美国、60611
        • Lurie Children's Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Medical Center
    • Missouri
      • St Louis、Missouri、美国、63110
        • Washington University in St. Louis School of Medicine
    • New York
      • New York、New York、美国、10032
        • Children's Hospital of New York
      • The Bronx、New York、美国、10803
        • Children's Hospital at Montefiore
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • The Children's Hospital of Philadelphia
      • Pittsburgh、Pennsylvania、美国、15224
        • Children's Hospital of Pittsburgh of University of Pittsburgh School of Medicine
    • Texas
      • Dallas、Texas、美国、75235
        • Children's Health Dallas University of Texas Southwestern
      • Houston、Texas、美国、77027
        • Texas Children's Hospital
    • Utah
      • Salt Lake City、Utah、美国、84132
        • Primary Children's Hospital
    • Washington
      • Seattle、Washington、美国、98105
        • Seattle Children's Hospital
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Children's Hospital 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

不超过 21年 (孩子、成人)

接受健康志愿者

不

描述

纳入标准：

  1. 原位心脏移植
  2. 移植时年龄 < 21 岁
  3. 随机分组时免疫抑制稳定，无依维莫司、他克莫司或吗替麦考酚酯的禁忌症
  4. 计划在研究地点进行为期 30 个月的后续研究。
  5. 能够提供知情同意的受试者或法定成年代表（一般情况下，将征求 12 岁或以上儿童的同意）。

排除标准：

  1. 多器官移植（例如 心肺或心肝）。
  2. 已知对依维莫司、西罗莫司、他克莫司或霉酚酸酯 (MMF) 或药品成分过敏。
  3. 接受维持性皮质类固醇治疗的患者在随机分组时剂量超过强的松 0.1 mg/kg/天。
  4. 排斥高风险定义为主动排斥、复发性（≥ 2 次 2R 级排斥反应）细胞排斥反应、复发性排斥反应（≥ 2 次任何级别的排斥反应）伴有血流动力学损害、类固醇耐药排斥反应或未解决的抗体介导排斥反应心脏移植后6个月
  5. 移植物功能障碍（LVEF <40% 或楔压 >22 mmHg 或心脏指数 <2.2 升/分/平方米)
  6. CKD 4 期或 5 期（eGFR <30 ml/min/1.73 平方米）
  7. 中度或重度蛋白尿
  8. 活动性感染需要住院治疗或药物治疗。
  9. 存在持续伤口愈合问题、需要继续治疗的临床显着伤口感染或现场首席研究员认为存在其他严重手术并发症的患者。
  10. 空腹血清胆固醇≥300 mg/dL 或大于或等于 7.75 mmol/L，并且空腹甘油三酯≥正常上限 (ULN) 的 2.5 倍。 注意：如果超过其中一个或两个阈值，则只有在开始使用适当的降脂药物并确认血清胆固醇和甘油三酯水平降低至排除范围以下后，才能纳入患者。
  11. 不受控制的糖尿病。
  12. 在心脏移植后的前 6 个月内诊断出移植后淋巴增生性疾病 (PTLD)。
  13. 不遵守医疗方案的历史。
  14. 接受细胞色素 P450 3A4 (CYP3A4) 强诱导剂或抑制剂药物治疗且不能停止治疗的患者
  15. 在研究期间怀孕或哺乳或打算怀孕的患者。

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：依维莫司/低剂量他克莫司

依维莫司大约 0.6 mg/m2/剂量，每 12 小时口服一次，持续 30 个月。 调整依维莫司剂量以达到 3-8 ng/ml 的谷浓度。

他克莫司 0.0125 mg/kg/剂量，每 12 小时口服一次，持续 30 个月。 （将调整他克莫司剂量以达到 3-5 ng/ml 的谷浓度，直到受试者在心脏移植后 1 年。 心脏移植后 1 年后，将调整他克莫司剂量以达到 2.5-4.5 ng/mL 的谷浓度。）
药品：依维莫司
依维莫司片
其他名称：
  • 佐特雷斯
药品：他克莫司
他克莫司胶囊或悬浮液
其他名称：
  • 程序
有源比较器：他克莫司/吗替麦考酚酯

他克莫司 0.05 mg/kg/剂量，每 12 小时口服一次，持续 30 个月。 （将调整他克莫司剂量以达到 7-10 ng/ml 的谷浓度，直到受试者在心脏移植后 1 年。 心脏移植后 1 年后，将调整他克莫司剂量以达到 5-8 ng/mL 的谷浓度。）

霉酚酸酯 600 mg/m2/剂量，每 12 小时口服一次，持续 30 个月。
药品：他克莫司
他克莫司胶囊或悬浮液
其他名称：
  • 程序
药品：霉酚酸酯
霉酚酸酯胶囊或悬浮液
其他名称：
  • 赛普普

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
EFFICACY: MATE-3 Score
大体时间：30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
30 months post-randomization
SAFETY: MATE-6 Score
大体时间：30 months post-randomization
MATE-6 is a validated score ranging from 0 to 24. The score adds together each subscore so that it represents the cumulative burden of all six major adverse transplant events: Coronary Artery Vasculopathy (CAV), Chronic Kidney Disease (CKD), Biopsy-proven Acute Cellular Rejection (ACR), pathologic diagnosis of Antibody-Mediated Rejection (AMR), Infection, and Post-Transplant Lymphoproliferative Disorder (PTLD). Complete details of the score can be found in the study protocol. A higher score represents a worse outcome.
30 months post-randomization

次要结果测量

结果测量
措施说明
大体时间
Efficacy: Overall Patient Survival
大体时间：Up to 30 months post-randomization
Number of participants who experienced death from any cause
Up to 30 months post-randomization
Efficacy: Overall Allograft Survival
大体时间：Up to 30 months post-randomization
Number of participants who experienced death or heart re-transplantation
Up to 30 months post-randomization
Efficacy: Change in Kidney Function
大体时间：0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Change in estimated glomerular filtration rate (eGFR) using the modified Schwartz equation. A positive number indicates improved kidney function, a negative number indicates worsened kidney function.
0 to 6 months, 0 to 12 months, 0 to 30 months post-randomization
Efficacy: Freedom From CKD Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE. A chronic kidney disease MATE was defined as an eGFR < 60 ml/min/1.73 m^2 during follow-up or worsening by at least one MATE score if < 60 ml/min/1.73 m^2 at baseline. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From CAV Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) cardiac allograft vasculopathy (CAV) during follow up as graded by the angiography core laboratory. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From BP-ACR Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) biopsy-proven Acute Cellular Rejection (ACR) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite Failure
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) the composite of death, graft loss, 2R/3R acute cellular rejection or rejection with hemodynamic compromise. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: EuroQOL EQ-5D Y (Youth Version)
大体时间：30 months post-randomization
The EuroQOL EQ-5D Y uses a visual-analog scale and asks the participant to mark an X on the line to show how good or bad your is health TODAY. The scale ranges from 0 to 100.
30 months post-randomization
Safety: Freedom From AMR
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a pathologic diagnosis of Antibody-Mediated Rejection (AMR) MATE Event. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Infection
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a serious infection MATE during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From PTLD
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a Post-Transplant Lymphoproliferative Disorder (PTLD) MATE event during follow-up. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Number of Participants Experiencing Adverse Events
大体时间：From enrollment to 30 months after enrollment
Adverse events reported throughout the study. Adverse events are classified by CTCAE classification. Serious adverse events include CTCAE classes 3, 4, and 5.
From enrollment to 30 months after enrollment
Safety: Freedom From Major Transplant Events (Composite)
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) any MATE event, this includes chronic kidney disease, cardiac allograft vasculopathy, acute cellular rejection, antibody mediated rejection, serious infection, and post-transplant lymphoproliferative disease. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CKD Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a chronic kidney disease MATE of Grade 2 or greater (eGFR <45 ml/min/1.73 m^2 or on dialysis) or death due to chronic kidney disease. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity CAV Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a cardiac allograft vasculopathy MATE of Grade 2 or greater. Grade 2 or greater is the same as having International Society of Heart and Lung Transplantation cardiac allograft vasculopathy Grade 2 or 3 or death due to cardiac allograft vasculopathy. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity ACR Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) an acute cellular rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart & Lung Transplantation acute cellular rejection grade 2 or grade 3 or rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to acute cellular rejection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity AMR Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) an antibody mediated rejection MATE of Grade 2 or greater. Grade 2 or greater is the equivalent of treated rejection with an assigned International Society of Heart & Lung Transplantation antibody mediated rejection grade 2 or grade 3 or antibody mediated rejection with hemodynamic compromise (decreased ejection fraction, need for IV medicine to support heart, need for mechanical circulatory support) or death due to antibody mediated rejection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity Infection Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a serious infection MATE of Grade 2 or greater. Grade 2 infections require treatment with intravenous antibiotics or antivirals for 5 or more days. Grade 3 includes treatment of sepsis, endocarditis, invasive infection, or infection leading to respiratory failure. Grade 4 is death due to infection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Safety: Freedom From Grade 2 or Greater Severity PTLD Event
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) a post-transplant lymphoproliferative disease MATE of Grade 2 or greater. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Freedom From Composite of CAV, CKD, BP-ACR, or Any CMV Infection
大体时间：From enrollment to 30 months after enrollment
Number of participants who are "free from" (have NOT experienced) at least one of cardiac allograft vasculopathy, chronic kidney disease with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73m2, treated acute cellular rejection, or any cytomegalovirus infection. A higher number of participants on this measure indicates a better outcome.
From enrollment to 30 months after enrollment
Efficacy: Change in CKD Stage
大体时间：Baseline visit through 30 months post-randomization
Change in chronic kidney disease stage where improvements in CKD stage can take on a negative value.
Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Calculated by Change From Baseline Visit
大体时间：Baseline visit through 30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in MATE-CKD score from baseline visit through 30 months post-randomization. CKD change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: MATE-3 Score Where CKD Score is Replaced by Change in CKD Stage
大体时间：Baseline visit through 30 months post-randomization
MATE-3 is a validated score ranging from 0 to 12. The score adds together each subscore so that it represents the cumulative burden of three major adverse transplant events: Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). For this version of the score, the chronic kidney disease score is replaced by the change in chronic kidney disease stage from the baseline visit through 30 months post-randomization. Chronic kidney disease stage change score can assume a negative value. This modified score can range from -2 to 12. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, MATE CKD Score, and Any CMV Infection.
大体时间：Baseline visit through 30 months post-randomization
Composite score ranging from 0 to 16. The score adds each subscore to represent the cumulative burden of three major adverse transplant events plus CMV infection. The three major adverse transplant events are Cardiac Allograft Vasculopathy (CAV), Chronic Kidney Disease (CKD), and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. Full details of the score can be found in the protocol. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Composite Score Consisting of MATE CAV, MATE BP-ACR, Change in CKD Stage, and Any CMV Infection.
大体时间：Baseline visit through 30 months post-randomization
Composite score ranging from -2 to 16. The score adds each subscore to represent the cumulative burden of Cardiac Allograft Vasculopathy (CAV), chronic kidney disease, and Biopsy-proven Acute Cellular Rejection (ACR). Any CMV infection is assigned a score of 1 with additional points using the MATE infection scoring criteria. The chronic kidney disease MATE score is replaced by change in CKD stage. A higher score represents a worse outcome.
Baseline visit through 30 months post-randomization
Efficacy: Lansky Scores
大体时间：Baseline
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Baseline
Efficacy: Lansky Scores
大体时间：18 months post-randomization
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
18 months post-randomization
Efficacy: Lansky Scores
大体时间：30 months post-randomization
Validated functional performance score, assigned by clinician assessment: Lansky score is assigned if < 16 years old at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
30 months post-randomization
Efficacy: Karnofsky Scores
大体时间：Baseline
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
Baseline
Efficacy: Karnofsky Scores
大体时间：18 months post-randomization
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
18 months post-randomization
Efficacy: Karnofsky Scores
大体时间：30 months post-randomization
Validated functional performance score, assigned by clinician assessment: Karnofsky score is assigned if >=16 years at randomization. Each score is on a 10-100 point scale and is assigned in 10-point increments (i.e. 10, 20, 30, etc.). A higher score represents a better outcome.
30 months post-randomization

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Boston Children's Hospital

合作者

United States Department of Defense
Stanford University

调查人员

  • 学习椅：Christopher S Almond, MD, MPH、Stanford University
  • 学习椅：Kevin P Daly, MD、Boston Children's Hospital
  • 首席研究员：Lynn A Sleeper, ScD、Boston Children's Hospital

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

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)

2018年1月29日

初级完成 (实际的)

2023年4月17日

研究完成 (实际的)

2023年5月17日

研究注册日期

首次提交

2017年12月18日

首先提交符合 QC 标准的

2017年12月21日

首次发布 (实际的)

2017年12月29日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年4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

  • P00025970
  • PR160574 (其他赠款/资助编号：U.S. Department of Defense)
  • IND 127980 (其他标识符：Food and Drug Administration)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

在美国制造并从美国出口的产品

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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