이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

중국 피험자의 편두통 예방을 위한 리메게판트의 안전성 및 효과에 대해 알아보기 위한 연구.

2026년 8월 12일 업데이트: Pfizer

중국 참가자의 편두통 예방을 위한 리메게판트의 효능 및 안전성을 평가하기 위한 3상, 무작위, 이중맹검, 위약 대조 연구

이 연구의 목적은 편두통 예방에 도움이 되는 Rimegepant의 효과에 대해 알아보는 것입니다.

이 연구는 다음과 같은 참가자를 찾고 있습니다.

  • 18세 이상의 남녀입니다.
  • 편두통 병력이 최소 1년 이상 있어야 합니다.
  • 이 연구를 시작하기 전에 편두통 치료제를 복용하지 않았습니다. 연구는 4단계 및 11회의 방문을 포함하여 약 30주 동안 계속됩니다. 연구를 위해 선택된 참가자는 치료 그룹에 무작위로 배정됩니다. 그 후 참가자는 12주 이중 맹검 치료(DBT) 단계에 들어갑니다. DBT 단계를 마친 후 일부 선택된 참가자는 12주 오픈 라벨 확장(OLE) 단계에 들어갈 수 있습니다. 참가자는 치료 종료(EOT) 방문을 위해 24주 말에 연구 현장으로 돌아올 것입니다. EOT 방문 후 약 14일 후에 후속 2주차 방문이 있을 것입니다.

참가자는 격일로 연구 약 1정을 복용해야 합니다. 당일 편두통이 있는지 여부에 관계없이 이를 따라야 합니다. OLE 단계 동안에만 참가자가 예정되지 않은 투약일에 편두통이 있는 경우, Rimegepant 구강붕해정(ODT) 1정을 편두통에 대한 급성 치료제로 복용할 수 있으며, 필요한 경우 최대 1정을 복용할 수 있습니다. 달력 일당 Rimegepant. 연구 팀은 연구 클리닉을 정기적으로 방문하는 동안 각 참가자가 연구 치료를 어떻게 하고 있는지 살펴볼 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

787

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
      • Beijing, 중국, 100044
        • Peking University People's Hospital
      • Changzhi, 중국, 046000
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chongqing, 중국, 404000
        • Chongqing University Three Gorges Hospital
      • Tianjin, 중국, 300000
        • Tianjin Union Medical Center
    • Anhui
      • Hefei, Anhui, 중국, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing Municipality, 중국, 100050
        • Beijing Friendship hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, 중국, 400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing Municipality, 중국, 400010
        • The fourth people's hospital of chongqing
    • Fujian
      • Fuzhou, Fujian, 중국, 350025
        • The 900th Hospital of Joint Logistics Support Force, PLA
    • Gansu
      • Lanzhou, Gansu, 중국, 730030
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510180
        • Guangzhou First People's Hospital
    • Hainan
      • Haikou, Hainan, 중국, 570311
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, 중국, 050051
        • Hebei General Hospital
    • Henan
      • Zhengzhou, Henan, 중국, 450014
        • People's Hospital of Zhengzhou
    • Hubei
      • Wuhan, Hubei, 중국, 430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Changsha, Hunan, 중국, 410013
        • The Third XIANGYA Hospital of Central South University
    • Inner Mongolia
      • Baotou, Inner Mongolia, 중국, 014010
        • The First Affiliated Hospital of Baotou Medical College
    • Jiangsu
      • Lianyungang, Jiangsu, 중국, 222002
        • The Second People's Hospital of Lianyungang
      • Nanjing, Jiangsu, 중국, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, 중국, 215004
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, 중국, 215006
        • The First Affiliated Hospital of Suzhou University
      • Wuxi, Jiangsu, 중국, 214023
        • Wuxi People's Hospital
      • Wuxi, Jiangsu, 중국, 214043
        • Wuxi No. 2 People's Hospital
      • Yangzhou, Jiangsu, 중국, 225001
        • Subei People's Hospital of Jiangsu province
      • Zhenjiang, Jiangsu, 중국, 212001
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Pingxiang, Jiangxi, 중국, 337055
        • Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, 중국, 130000
        • The First Hospital of Jilin University
      • Changchun, Jilin, 중국, 130000
        • The Second Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, 중국, 110067
        • The People's Hospital of Liaoning Province
    • Ningxia
      • Yinchuan, Ningxia, 중국, 750003
        • General Hospital of Ningxia Medical Hospital
    • Shaanxi
      • Xi'an, Shaanxi, 중국, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, 중국, 710068
        • Shaanxi Provincial People's Hospital
      • Xianyang, Shaanxi, 중국, 712000
        • Xianyang Hospital of Yan'an University
    • Shandong
      • Dongying, Shandong, 중국, 257099
        • Shengli Oilfield Central Hospital
      • Jinan, Shandong, 중국, 250012
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, 중국, 250013
        • Jinan Central Hospital
      • Jining, Shandong, 중국, 272000
        • Affiliated Hospital of Jining Medical University
      • Liaocheng, Shandong, 중국, 252000
        • Liaocheng People's Hospital
      • Linyi, Shandong, 중국, 276034
        • Linyi People's Hospital
      • Qingdao, Shandong, 중국, 266042
        • Qingdao Central Hospital
      • Rizhao, Shandong, 중국, 276800
        • People's Hospital of Rizhao
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200040
        • Huashan Hospital Fudan University
      • Shanghai, Shanghai Municipality, 중국, 200123
        • Shanghai East Hospital
    • Shanxi
      • Taiyuan, Shanxi, 중국, 030001
        • The First Hospital of Shanxi Medical University
    • Yunnan
      • Kunming, Yunnan, 중국, 650032
        • First Affiliated Hospital of Kunming Medical University
      • Kunming, Yunnan, 중국, 650000
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310016
        • Sir Run Run Shaw Hospital
      • Wenzhou, Zhejiang, 중국, 325000
        • The First Affiliated Hosptial of Wenzhou Medical University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

1. 대상 모집단: 참가자는 다음을 포함하여 국제 두통 장애 분류, 제3판에 따른 진단과 일치하는 편두통(조짐이 있거나 없는) 병력이 최소 1년 이상 있습니다.

  1. 50세 이전의 편두통 발병 연령
  2. 편두통 발작은 치료하지 않으면 평균 4~72시간 지속됩니다.
  3. 참가자 보고서당, 스크리닝 방문 전 마지막 3개월 이내에 매월 중등도 또는 중증 강도의 편두통 발작 4~18회(이 프로토콜의 목적을 위해 한 달은 4주로 정의됨)
  4. 관찰 단계 동안 6일 이상의 편두통
  5. 관찰 단계 동안 18일 이하
  6. 편두통 발작과 긴장성/군발성 두통을 구별하는 능력.
  7. 트립탄 사용에 대한 금기 사항이 있는 참가자는 다른 모든 연구 참가 기준을 충족하는 경우 포함될 수 있습니다.

제외 기준:

  1. 참가자는 기저 편두통 또는 편마비 편두통의 병력이 있습니다.
  2. 스크리닝 방문 전 3개월 중 어느 한 달에 한 달에 19일 이상(편두통 또는 비편두통) 발생하는 두통이 있는 참가자.
  3. 연구자의 판단에 따라 지난 3년 동안 적절한 치료 시도 후 편두통 예방 치료의 9개 약물 범주 중 > 2개에서 치료 반응이 없는 참가자는 제외됩니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: DBT 리메게판트/OLE 리메게판트

DBT 단계(1~12주): 참가자는 12주 동안 rimegepant 구강 붕해 정제(ODT) EOD를 단일 경구 투여받습니다.

OLE 단계(13주에서 24주): 연구 참여 기준을 계속 충족하는 참가자는 OLE 단계에 들어가 12주 동안 rimegepant ODT EOD의 단일 경구 투여를 받습니다. 참가자가 rimegepant를 투여할 예정이 없는 날에 편두통이 있는 경우, 해당 날짜에 rimegepant ODT 1정을 복용하여 편두통을 치료할 수 있습니다(필요에 따라 [PRN] 투여).
의약품: 리메판트
리메판트
다른 이름들:
  • PF-07899801, BHV-3000
위약 비교기: DBT 위약/OLE Rimepant

DBT 단계(1~12주): 참가자는 12주 동안 rimegepant ODT EOD와 일치하는 위약을 단일 경구 투여받습니다.

OLE 단계(13주에서 24주): 연구 참여 기준을 계속 충족하는 참가자는 OLE 단계에 들어가 12주 동안 rimegepant ODT EOD의 단일 경구 투여를 받습니다. 참가자가 rimegepant를 투여할 예정이 아닌 날에 편두통이 있는 경우, 해당 날짜에 rimegepant ODT 1정을 복용하여 편두통을 치료할 수 있습니다(PRN 투여).
의약품: 위약
일치하는 위약
의약품: 리메판트
리메판트
다른 이름들:
  • PF-07899801, BHV-3000

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
기간: OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 12)
A migraine day(MD) was defined as any calendar day participant experienced a qualified migraine headache (onset,continuation,or recurrence), per electronic diary(eDiary). A qualified migraine headache was defined as a migraine with/without aura,lasted for >=30 minutes with >=2 pain features (unilateral location,pulsating quality[throbbing],moderate/severe pain intensity,aggravated by or caused avoidance of routine physical activity [e.g. walking/climbing stairs]) and/or with >=1 of the following associated symptoms (nausea and/or vomiting, both photophobia and phonophobia).The number(no.) of md per month (m) was prorated to 28 days and derived as:OP:28*[total no.of MD in OP analysis period]/(total no.of efficacy data day in OP analysis period), monthly (4-week interval) on-DBT efficacy analysis period: 28*(total no.of MD in m)/(total no. of efficacy data days in m),overall DBT in on-DBT efficacy analysis period:28*(total no.of MD through m3)/(total no.of efficacy data day through m3).
OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 12)

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With >=50% Reduction From the OP in the Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
기간: OP (screening of 4 weeks prior to randomization), DBT Phase (Weeks 1 to 12)
A MD was defined as any calendar day participant experienced a qualified migraine headache(onset,continuation,or recurrence),per eDiary. A qualified migraine headache was defined as a migraine with/without aura,lasted for >=30 minutes with >=2 pain features(unilateral location,pulsating quality [throbbing], moderate/severe pain intensity, aggravated by or caused avoidance of routine physical activity [e.g. walking/climbing stairs]) and/or with >=1 of the following associated symptoms(nausea and/or vomiting, both photophobia and phonophobia).The number of MD per month was prorated to 28 days and derived as: OP: 28*[total number of MD in OP analysis period]/(total number of efficacy data days in OP analysis period), monthly (4-week interval) on-DBT efficacy analysis period: 28*(total number of MD in month)/(total number of efficacy data days in month),overall DBT in on-DBT efficacy analysis period:28*(total number of MD through month 3)/(total no .of efficacy data days through month 3).
OP (screening of 4 weeks prior to randomization), DBT Phase (Weeks 1 to 12)
Mean Change From the OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of the DBT Phase
기간: OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 4)
A MD was defined as any calendar day participant experienced a qualified migraine headache(onset,continuation,or recurrence),per eDiary. A qualified migraine headache was defined as a migraine with/without aura,lasted for >=30 minutes with >=2 pain features (unilateral location,pulsating quality[throbbing],moderate/severe pain intensity,aggravated by or caused avoidance of routine physical activity[e.g. walking/climbing stairs]) and/or with >=1 of the following associated symptoms (nausea and/or vomiting, both photophobia and phonophobia).The number of MD per month was prorated to 28 days and derived as:OP:28*[total number of MD in OP analysis period]/(total number of efficacy data days in OP analysis period), monthly (4-week interval) on-DBT efficacy analysis period: 28*(total number of MD in month)/(total number of efficacy data days in month), overall DBT in on-DBT efficacy analysis period:28*(total number of MD through month 3)/(total number of efficacy data days through month 3).
OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 4)
Mean Change From the OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase
기간: OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 9 to 12)
A MD was defined as any calendar day participant experienced a qualified migraine headache(onset,continuation,or recurrence),per eDiary. A qualified migraine headache was defined as a migraine with/without aura,lasted for >=30 minutes with >=2 pain features (unilateral location,pulsating quality[throbbing],moderate/severe pain intensity,aggravated by or caused avoidance of routine physical activity [e.g. walking/climbing stairs]) and/or with >=1 of the following associated symptoms (nausea and/or vomiting, both photophobia and phonophobia).The number of MD per month was prorated to 28 days and derived as:OP:28*[total number of MD in OP analysis period]/(total number of efficacy data days in OP analysis period), monthly (4-week interval) on-DBT efficacy analysis period: 28*(total number of MD in month)/(total number of efficacy data days in month),overall DBT in on-DBT efficacy analysis period:28*(total number of MD through month 3)/(total number of efficacy data days through month 3).
OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 9 to 12)
Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase
기간: Baseline, DBT phase (Week 12)
MSQoL:14-item instrument validated in 3 domains:restrictive role function,preventative role function and emotional function.Role function-restrictive domain consisted of 7 items that described how migraine limits one's daily social and work-related activities.Participants were required to respond to items using a 6-point scale ranging from 1-6, where 1=none of the time,2=little bit of the time,3=some of the time,4=good bit of the time,5=most of the time and 6=all of the time.Item scores were recorded using(7-original score).Raw dimension scores for restrictive role function domain were computed as a sum of recorded item scores(7-42) and rescaled from 0-100 scale such that lowest score(0) indicated poor quality of life(QOL) and highest scores(100) indicated better QOL.Change from baseline was calculated as MSQoL role function-restrictive domain score at Week 12 of DBT phase minus MSQoL role function-restrictive domain score at baseline.Data collected on Day 1 was referred to Baseline.
Baseline, DBT phase (Week 12)
Mean Number of Acute Migraine Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
기간: DBT phase (Weeks 1 to 12)
Acute migraine-specific medication day was defined as any calendar day during which the participant took a migraine-specific medication (triptan). Acute migraine medication days were defined as either acute migraine-specific medication day or migraine day with "yes" response to the question about taking other medications to treat headache or aura. The number of migraine day per month was prorated to 28 days and derived as: OP: 28*[total number of migraine day in the OP analysis period]/(total number of efficacy data days in the OP analysis period), monthly (i.e., 4-week interval) in the on-DBT efficacy analysis period: 28*(total number of migraine day in the month)/(total number of efficacy data days in the month), overall DBT in the on-DBT efficacy analysis period: 28*(total number of migraine day through month 3)/(total number of efficacy data days through month 3).
DBT phase (Weeks 1 to 12)
Number of Participants With Any On-Treatment Adverse Events (AEs) by Severity During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were graded per the common terminology criteria for adverse events (CTCAE) as grade 1 indicates mild AE, grade 2 indicates moderate AE, grade 3 indicates severe AE, grade 4 indicates life-threatening consequences and urgent intervention, and grade 5 indicates death related to AE. Number of participants who had grade 3 or 4 AEs were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Serious Adverse Events (SAEs) On-Treatment During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An SAE was any event that met any of the criteria: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant were considered an important medical event.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With AEs Leading to Study Intervention Discontinuation During the DBT Phase
기간: DBT phase: maximum of 12 weeks
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with AEs leading to discontinuation of study intervention during the DBT phase were reported.
DBT phase: maximum of 12 weeks
Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Test Abnormalities During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Laboratory test included hematology (hemoglobin, lymphocytes, white blood cell count [high, low], neutrophils and platelets), serum chemistry (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], albumin, bilirubin, creatine kinase [CK], calcium [high, low], glucose fasting and non-fasting [high, low], cholesterol [total], glucose [low], creatinine, LDL cholesterol, potassium, sodium [high, low], triglycerides, uric acid [urate] and estimated glomerular filtration rate [eGFR] modification of diet in renal disease [MDRD]) and urinalysis (urine glucose and urine protein). Laboratory abnormalities were graded according to CTCAE as grade 3 indicates severe AE, grade 4 indicates life-threatening consequences and urgent intervention. Number of participants who had non-zero grade 3 to 4 laboratory test abnormalities were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Any On-Treatment AEs by Severity During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. AEs were graded per the CTCAE as grade 1 indicates mild AE, grade 2 indicates moderate AE, grade 3 indicates severe AE, grade 4 indicates life-threatening consequences and urgent intervention, and grade 5 indicates death related to AE. Number of participants who had grade 3 or 4 AEs were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With SAEs On-Treatment During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An SAE was any event that met any of the criteria: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant were considered an important medical event.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With AEs Leading to Study Intervention Discontinuation on Treatment During the OLE Phase
기간: OLE phase: maximum of 12 weeks
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with AEs leading to discontinuation of study intervention during the OLE phase were reported.
OLE phase: maximum of 12 weeks
Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Test Abnormalities During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Laboratory test included hematology (hemoglobin, lymphocytes, white blood cell count [high, low], neutrophils and platelets), serum chemistry (ALP, ALT, AST, albumin, bilirubin, CK, calcium [high, low], glucose fasting and non-fasting [high, low], cholesterol [total], glucose [low], creatinine, LDL cholesterol, potassium, sodium [high, low], triglycerides, uric acid [urate] and eGFR MDRD) and urinalysis (urine glucose and urine protein). Laboratory abnormalities were graded according to CTCAE as grade 3 indicates severe AE, grade 4 indicates life-threatening consequences and urgent intervention. Number of participants who had non-zero grade 3 to 4 laboratory test abnormalities were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With ALT or AST Elevations >3* Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) Elevations >2*ULN On-Treatment During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of participants with ALT or AST elevations >3*ULN concurrent with TBL elevations >2*ULN in DBT phase were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With ALT or AST Elevations >3*ULN Concurrent With TBL Elevations >2*ULN On-Treatment During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of participants with ALT or AST elevations >3*ULN concurrent with TBL elevations >2*ULN in OLE phase were reported in this outcome measure.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Hepatic-related AEs On-Treatment During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with hepatic-related AEs during the DBT phase were reported.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Hepatic-related AEs Leading to Study Intervention Discontinuation On-Treatment During the DBT Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with hepatic-related AEs leading to discontinuation of study intervention during the DBT phase were reported.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Hepatic-related AEs On-Treatment During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with hepatic-related AEs during the OLE phase were reported.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
Number of Participants With Hepatic-Related AEs Leading to Study Intervention Discontinuation On-Treatment During the OLE Phase
기간: From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. In this outcome measure participants with hepatic-related AEs leading to discontinuation of study intervention during the OLE phase were reported.
From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 5월 15일

기본 완료 (실제)

2025년 8월 25일

연구 완료 (실제)

2025년 12월 10일

연구 등록 날짜

최초 제출

2023년 3월 30일

QC 기준을 충족하는 최초 제출

2023년 3월 30일

처음 게시됨 (실제)

2023년 4월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 12일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • C4951019 (Alias Study Number)
  • BHV3000-319 (기타 식별자: Alias Study Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

화이자는 식별되지 않은 개별 참가자 데이터 및 관련 연구 문서(예: 프로토콜, 통계 분석 계획(SAP), 임상 연구 보고서(CSR)) 자격을 갖춘 연구자의 요청에 따라 특정 기준, 조건 및 예외가 적용됩니다. 화이자의 데이터 공유 기준 및 액세스 요청 프로세스에 대한 자세한 내용은 https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests에서 확인할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다