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一项了解 Zavegepant 作为亚洲成人偏头痛急性治疗药物的研究

2026年4月29日 更新者：Pfizer

一项旨在评估 Zavegepant 鼻内 (IN) 治疗亚洲成人偏头痛急性治疗的有效性和安全性的 3 期、随机、双盲、安慰剂对照、平行组研究

本研究的目的是了解 zavegepant 与安慰剂相比在亚洲成人偏头痛急性治疗中的安全性和有效性。 偏头痛是一种非常痛苦的头痛，并伴有其他相关症状，如恶心、畏光和恐声症。 安慰剂是一种无害的治疗方法，没有医疗作用。

这项研究正在寻找以下参与者：

  • 在进入研究之前至少有 1 年的偏头痛病史。
  • 在进入研究之前的 3 个月内，每年有 2 至 8 次中度或重度偏头痛发作。
  • 在进入研究之前的 3 个月内，每年头痛的时间少于 15 天。 头痛可能是由偏头痛引起的，也可能不是。

本研究的参与者将通过鼻内途径接受 zavegepant 或安慰剂。 鼻内给药是指通过鼻子给药的药物。 如果参与者有中度或重度偏头痛，将服用 Zavegepant 或安慰剂。

该研究将比较接受 zavegepant 的人和接受安慰剂的人的经历。 这将有助于了解 zavegepant 对亚洲成年人是否安全有效。

参与者将参与这项研究长达约 16 周。 参与者将在研究诊所进行 3 次研究访问，并通过电话联系进行 1 次。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1414

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、100044
        • Peking University People's Hospital
      • Beijing、中国、100053
        • Xuanwu Hospital Capital Medical University
      • Chongqing、中国、404000
        • Chongqing University Three Gorges Hospital
      • Chongqing、中国
        • The fourth people's hospital of chongqing
      • Shanghai、中国、200120
        • Shanghai East Hospital
      • Tianjin、中国、300000
        • Tianjin Union Medical Center
    • Anhui
      • Hefei、Anhui、中国、230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing、Beijing Municipality、中国、100853
        • The First Medical Center of Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Hainan
      • Haikou、Hainan、中国、570311
        • Hainan General Hospital
    • Hebei
      • Wuhan、Hebei、中国、430060
        • Renmin Hospital of Wuhan University
    • Henan
      • Luoyang、Henan、中国、471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Luoyang、Henan、中国、471000
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou、Henan、中国、450000
        • People's Hospital of Zhengzhou
    • Hubei
      • Wuhan、Hubei、中国、430074
        • Wuhan Third Hospital
    • Hunan
      • Changsha、Hunan、中国、410013
        • The Third XIANGYA Hospital of Central South University
      • Changsha、Hunan、中国、410004
        • Changsha Central Hospital
    • Jiangsu
      • Lianyungang、Jiangsu、中国、222006
        • The Second People's Hospital of Lianyungang
      • Nanjing、Jiangsu、中国、210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou、Jiangsu、中国、215004
        • The Second Affiliated Hospital of Soochow University
      • Wuxi、Jiangsu、中国、214023
        • Wuxi People's Hospital
      • Wuxi、Jiangsu、中国、214125
        • Affiliated Hospital of Jiangnan University
      • Zhenjiang、Jiangsu、中国、212008
        • The Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Pingxiang、Jiangxi、中国、337055
        • Pingxiang People's Hospital
    • Jilin
      • Changchun、Jilin、中国、130000
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang、Liaoning、中国、110016
        • The People's Hospital of Liaoning Province
    • Ningxia
      • Yinchuan、Ningxia、中国、750001
        • The First People's Hospital of Yinchuan
      • Yinchuan、Ningxia、中国、750003
        • General Hospital of Ningxia Medical Hospital
    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an、Shaanxi、中国、710068
        • Shaanxi Provincial People' Hospital
      • Xi'an、Shaanxi、中国、710075
        • Xian Gaoxin Hospital
      • Xianyang、Shaanxi、中国、716099
        • Xianyang Hospital of Yan'an University
    • Shandong
      • Jinan、Shandong、中国、250012
        • Qilu Hospital of Shandong University
      • Jinan、Shandong、中国、250013
        • Jinan Central Hospital
      • Jining、Shandong、中国、272000
        • Affiliated Hospital of Jining Medical University
      • Liaocheng、Shandong、中国、252000
        • Liaocheng People's Hospital
      • Qingdao、Shandong、中国、266042
        • Qingdao Central Hospital
      • Rizhao、Shandong、中国、276800
        • People's Hospital of Rizhao
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huashan Hospital, Fudan University
      • Shanghai、Shanghai Municipality、中国、200123
        • Shanghai East Hospital
    • Shanxi
      • Changzhi、Shanxi、中国、046000
        • Heping Hospital Affiliated to Changzhi Medical College
    • Yunnan
      • Kunming、Yunnan、中国、650032
        • First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310016
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
      • Rui’an、Zhejiang、中国、325200
        • Ruian People's Hospital
      • Wenzhou、Zhejiang、中国、325000
        • The First Affiliated Hosptial of Wenzhou Medical University
  • 台湾
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital
      • Taipei、台湾、11490
        • Tri-Service General Hospital
      • Taoyuan、台湾、333
        • Chang Gung Medical Foundation-Linkou Branch
  • 韩国
      • Seoul、韩国、03181
        • Kangbuk Samsung Hospital
    • Gyeonggi-do
      • Seongnam-si、Gyeonggi-do、韩国、13620
        • Seoul National University Bundang Hospital
    • Kyǒnggi-do
      • Goyang-si、Kyǒnggi-do、韩国、10380
        • Inje University - Ilsan Paik Hospital
      • Hwaseong-si、Kyǒnggi-do、韩国、18450
        • Hallym University Dongtan Sacred Heart Hospital
      • Seongnam、Kyǒnggi-do、韩国、13620
        • Seoul National University Bundang Hospital
      • Uijeongbu-si、Kyǒnggi-do、韩国、11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
    • Pusan-kwangyǒkshi
      • Busan、Pusan-kwangyǒkshi、韩国、49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [seoul]
      • Seoul、Seoul-teukbyeolsi [seoul]、韩国、03080
        • Seoul National University Hospital
      • Seoul、Seoul-teukbyeolsi [seoul]、韩国、05505
        • Asan Medical Center
      • Seoul、Seoul-teukbyeolsi [seoul]、韩国、03722
        • Severance Hospital, Yonsei University Health System
      • Seoul、Seoul-teukbyeolsi [seoul]、韩国、01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul、Seoul-teukbyeolsi [seoul]、韩国、07804
        • Ewha Womans University Seoul 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

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 筛选时年龄为 18 岁或以上的亚洲参与者。

  • 筛选访视前至少有 1 年偏头痛病史（有或无先兆）的参与者，符合《国际头痛疾病分类》第三版的诊断，包括以下情况：

    1. 偏头痛发作持续 1 年以上，发病年龄在 50 岁之前。
    2. 如果不治疗，偏头痛发作平均会持续约 4-72 小时。
    3. 过去 3 个月内每月中度或重度疼痛发作不超过 8 次。
    4. 参与者必须能够区分偏头痛发作和紧张性/丛集性头痛。
    5. 在筛选访视前 3 个月和整个筛选阶段，每年至少有 2 次持续的中度或重度偏头痛发作（参与者自我报告）。
    6. 在筛选访视前 3 个月和整个筛选阶段，每月头痛（偏头痛或非偏头痛）的天数少于 15 天（参与者自我报告）。
    7. 如果接受预防性偏头痛药物的参与者在筛选访视前至少 3 个月保持稳定剂量，并且预计剂量在治疗结束访视期间不会发生变化，则允许他们继续接受治疗。
    8. 有曲坦类药物使用禁忌症的参与者只要符合所有其他研究进入标准即可被纳入。

排除标准：

  • 有视网膜偏头痛、基底偏头痛或偏瘫性偏头痛病史。
  • 不受控制、不稳定或最近诊断的心血管或心脏代谢疾病的病史或当前证据。
  • 重度抑郁症、焦虑症或其他严重的精神障碍。
  • 干扰研究评估的急性或慢性疼痛综合征、精神疾病、痴呆或严重神经系统疾病（偏头痛除外）。
  • 可能影响鼻用产品的给药或吸收的情况。
  • 药物过度使用引起的头痛。

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
安慰剂比较：安慰剂
药品：安慰剂
在治疗阶段服用单剂量的匹配安慰剂。
实验性的：扎韦格潘特
Zavegepant 鼻内 10 mg
药品：扎韦格潘特
参与者将在治疗阶段接受足以治疗 1 次中度或重度偏头痛的单次活性剂量。

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
Percentage of Participants With Pain Freedom at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
大体时间：At 2 hours post-dose
MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Pain Relief at 15 Minutes Post-dose
大体时间：At 15 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 15 minutes post-dose
Percentage of Participants With Pain Relief at 30 Minutes Post-dose
大体时间：At 30 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 30 minutes post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 2 hours post-dose
Percentage of Participants Who Returned to Normal Function at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
大体时间：From 2 hours post-dose to 24 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose
大体时间：From 2 hours post-dose to 48 hours post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). This outcome of sustained pain relief was defined as pain intensity being mild or none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants Who Returned to Normal Function at 30 Minutes Post-dose
大体时间：At 30 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 30 minutes post-dose) were reported.
At 30 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 60 Minutes Post-dose
大体时间：At 60 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 60 minutes post-dose) were reported.
At 60 minutes post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Freedom from phonophobia was defined as phonophobia absent at specified time point for participants with the phonophobia present at the time of dosing. In this outcome measure, percentage of participants who had phonophobia at the time of dosing and then recorded phonophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Freedom from photophobia was defined as photophobia absent at specified time point for participants with the photophobia present at the time of dosing. In this outcome measure, percentage of participants who had photophobia at the time of dosing and then recorded photophobia absent at the time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose
大体时间：At 2 hours post-dose
Freedom from nausea was defined as nausea absent at specified time point for participants with the nausea present at the time of dosing. In this outcome measure, percentage of participants who had nausea at the time of dosing and then recorded nausea absent at time of evaluation (i.e., 2 hours post-dose) were reported.
At 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose
大体时间：From 2 hours post-dose to 24 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 24 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose
大体时间：From 2 hours post-dose to 48 hours post-dose
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe). Sustained pain freedom was defined as pain intensity being none at all time points from 2 to 48 hours post-dose with missing data <=1 time point from 3 to 8 hours post-dose.
From 2 hours post-dose to 48 hours post-dose
Percentage of Participants With Pain Relapse at Any Time Point After 2 Hours Post-dose to 48 Hours Post-dose
大体时间：From after 2 hours post-dose to 48 hours post-dose
Pain relapse was defined as pain intensity of mild, moderate, or severe at any time point after 2 hours to 48 hours post-dose for participants with pain intensity of none at 2 hours post-dose. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
From after 2 hours post-dose to 48 hours post-dose
Percentage of Participants Taking Rescue Medication Within 24 Hours Post-dose
大体时间：Within 24 hours post-dose
Participants who did not experience relief (pain intensity of none or mild) of their migraine headache at the end of 2 hours post-dose, or the migraine was relieved at 2 hours post-dose, but then recurred to a moderate or severe pain intensity level, were permitted to use the following rescue medications: aspirin, ibuprofen, naproxen (or any other type of nonsteroidal anti-inflammatory drug), acetaminophen up to 1000 mg/day (this included Excedrin Migraine), antiemetics (for example, metoclopramide or promethazine), or baclofen.
Within 24 hours post-dose
Percentage of Participants With Pain Relief at 60 Minutes Post-dose
大体时间：At 60 minutes post-dose
Pain relief was defined as pain intensity being none or mild at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
At 60 minutes post-dose
Percentage of Participants Who Returned to Normal Function at 15 Minutes Post-dose
大体时间：At 15 minutes post-dose
Participants recorded their functional disability level using a 4-point numeric rating scale (0= normal, 1= mildly impaired, 2= severely impaired, 3= required bedrest). In this outcome measure, percentage of participants who had functional disability (mildly impaired, severely impaired, or required bedrest) at the time of dosing and then returned to normal function level at the time of evaluation (i.e., 15 minutes post-dose) were reported.
At 15 minutes post-dose
Number of Participants With Adverse Events (AEs) of Moderate or Severe Intensity: On-Treatment Period
大体时间：On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activity/activities of daily living (ADL), causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With AEs of Moderate or Severe Intensity: Follow-up Period
大体时间：Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Moderate AE: A type of AE that was usually alleviated with additional specific therapeutic intervention. The event interfered with usual ADL, causing discomfort, but posed no significant or permanent risk of harm to the research participant. Severe AE: A type of AE that interrupted usual ADL, or significantly affected clinical status, or might have required intensive therapeutic intervention.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Serious Adverse Events (SAEs): On-Treatment Period
大体时间：On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With SAEs: Follow-up Period
大体时间：Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic, or other situations.
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Local Irritation AEs: On-Treatment Period
大体时间：On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Local Irritation AEs: Follow-up Period
大体时间：Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local irritation AEs were associated with intranasal administration of study intervention (e.g., dysgeusia, nasal discomfort, oropharyngeal pain, throat irritation, and laryngeal discomfort).
Follow-up period: Follow-up period was after the EOT visit and through the follow-up visit, up to 33 days
Number of Participants With Grade 3 to 4 Hematological Test Abnormalities: On-Treatment Period
大体时间：On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Hematological test abnormalities included: anemia, eosinophilia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophils count decreased, platelet count decreased and white blood cell decreased. Only those hematology test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The hematological test abnormalities grade 3 to 4 were graded according to the common terminology criteria for adverse events (CTCAE) version (v) 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Number of Participants With Grade 3 to 4 Clinical Chemistry Test Abnormalities: On-Treatment Period
大体时间：On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 days
Clinical chemistry test abnormalities included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, creatine phosphokinase (CPK) increased, chronic kidney disease, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia and hyponatremia. Only those clinical chemistry test categories in which at least one participant in at least one reporting arm experienced a Grade 3 or Grade 4 abnormality were reported in this outcome measure. The clinical chemistry test abnormalities grade 3 to 4 were graded according to the CTCAE v 5.0.
On-treatment period: On-treatment period was from the administration of study intervention and through the EOT visit, up to 10 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

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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)

2023年11月29日

初级完成 (实际的)

2025年5月30日

研究完成 (实际的)

2025年5月30日

研究注册日期

首次提交

2023年8月3日

首先提交符合 QC 标准的

2023年8月3日

首次发布 (实际的)

2023年8月14日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年4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

  • C5301008
  • NCT05989048 (注册表标识符：ClinicalTrials.gov)

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

辉瑞将提供对个人去识别化参与者数据和相关研究文件（例如， 应合格研究人员的要求，并遵守某些标准、条件和例外情况，提供协议、统计分析计划 (SAP)、临床研究报告 (CSR)）。 有关辉瑞数据共享标准和请求访问流程的更多详细信息，请访问：https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。

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

是的

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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