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中国人被験者の片頭痛を予防するためのリメゲパントの安全性と効果について学ぶための研究。

2026年8月12日 更新者：Pfizer

中国人参加者における片頭痛予防のための Rimegepant の有効性と安全性を評価するための第 3 相、無作為化、二重盲検、プラセボ対照試験

この研究の目的は、片頭痛の予防に役立つリメゲパントの効果について学ぶことです。

この調査では、次のような参加者を求めています。

  • 18歳以上の男女です。
  • 少なくとも 1 年間の片頭痛の病歴がある。
  • この研究の開始前に片頭痛の薬を服用していませんでした。 この研究は、4 つのフェーズと 11 回の来院を含め、約 30 週間続きます。 研究のために選択された参加者は、無作為に治療グループに割り当てられます。 その後、参加者は 12 週間の二重盲検治療 (DBT) フェーズに入ります。 DBT フェーズの終了後、一部の選択された参加者は、12 週間の非盲検延長 (OLE) フェーズに入る場合があります。 参加者は、治療終了（EOT）訪問のために24週の終わりに研究サイトに戻ります。 EOT訪問の約14日後にフォローアップの第2週訪問があります。

参加者は、1 日おきに 1 錠の治験薬を服用するよう求められます。 これは、その日に片頭痛があるかどうかに関係なく、従う必要があります。 OLE フェーズの間のみ、参加者が予定外の投薬日に片頭痛を患っている場合、必要に応じて、片頭痛の急性治療として Rimegepant 口腔内崩壊錠 (ODT) 1 錠を最大 1 錠服用することができます。暦日あたりのリメゲパン。 研究チームは、研究クリニックでの定期的な訪問中に、各参加者が研究治療をどのように行っているかを調べます。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

787

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
      • Beijing、中国、100044
        • Peking University People's Hospital
      • Changzhi、中国、046000
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chongqing、中国、404000
        • Chongqing University Three Gorges 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、100853
        • Chinese PLA General Hospital
      • Beijing、Beijing Municipality、中国、100050
        • Beijing Friendship hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400016
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing、Chongqing Municipality、中国、400010
        • The fourth people's hospital of chongqing
    • Fujian
      • Fuzhou、Fujian、中国、350025
        • The 900th Hospital of Joint Logistics Support Force, PLA
    • Gansu
      • Lanzhou、Gansu、中国、730030
        • Lanzhou University Second Hospital
    • Guangdong
      • Guangzhou、Guangdong、中国、510180
        • Guangzhou First People's Hospital
    • Hainan
      • Haikou、Hainan、中国、570311
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang、Hebei、中国、050051
        • Hebei General Hospital
    • Henan
      • Zhengzhou、Henan、中国、450014
        • People's Hospital of Zhengzhou
    • Hubei
      • Wuhan、Hubei、中国、430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Changsha、Hunan、中国、410013
        • The Third XIANGYA Hospital of Central South University
    • Inner Mongolia
      • Baotou、Inner Mongolia、中国、014010
        • The First Affiliated Hospital of Baotou Medical College
    • Jiangsu
      • Lianyungang、Jiangsu、中国、222002
        • 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
      • Suzhou、Jiangsu、中国、215006
        • The First Affiliated Hospital of Suzhou University
      • Wuxi、Jiangsu、中国、214023
        • Wuxi People's Hospital
      • Wuxi、Jiangsu、中国、214043
        • Wuxi No. 2 People's Hospital
      • Yangzhou、Jiangsu、中国、225001
        • Subei People's Hospital of Jiangsu province
      • Zhenjiang、Jiangsu、中国、212001
        • 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
      • Changchun、Jilin、中国、130000
        • The Second Hospital of Jilin University
    • Liaoning
      • Shenyang、Liaoning、中国、110067
        • The People's Hospital of Liaoning Province
    • Ningxia
      • 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's Hospital
      • Xianyang、Shaanxi、中国、712000
        • Xianyang Hospital of Yan'an University
    • Shandong
      • Dongying、Shandong、中国、257099
        • Shengli Oilfield Central Hospital
      • 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
      • Linyi、Shandong、中国、276034
        • Linyi 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
      • Taiyuan、Shanxi、中国、030001
        • The First Hospital of Shanxi Medical University
    • Yunnan
      • Kunming、Yunnan、中国、650032
        • First Affiliated Hospital of Kunming Medical University
      • Kunming、Yunnan、中国、650000
        • The Second Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310016
        • Sir Run Run Shaw Hospital
      • Wenzhou、Zhejiang、中国、325000
        • The First Affiliated Hosptial of Wenzhou Medical University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

1.対象集団：参加者は、以下を含む国際頭痛分類第3版による診断と一致する片頭痛（前兆の有無にかかわらず）の病歴が少なくとも1年あります。

  1. 片頭痛の発症年齢が50歳未満
  2. 未治療の場合、片頭痛の発作は平均して 4 ～ 72 時間続きます
  3. 参加者の報告によると、スクリーニング訪問前の過去3か月以内に月あたり4〜18回の中等度または重度の片頭痛発作（このプロトコルの目的のために月は4週間と定義されています）
  4. 観察段階で片頭痛が 6 日以上
  5. 観察段階での頭痛日数は 18 日以内
  6. 片頭痛発作と緊張性/群発頭痛を区別する能力。
  7. トリプタンの使用が禁忌である参加者は、他のすべての試験参加基準を満たしている場合に含めることができます。

除外基準:

  1. -参加者は脳底片頭痛または片麻痺性片頭痛の病歴があります。
  2. -スクリーニング訪問前の3か月のいずれかで、頭痛が1か月に19日以上発生する参加者（片頭痛または非片頭痛）。
  3. 研究者の判断により、過去3年間の適切な治療試験の後、片頭痛の予防治療の9つの投薬カテゴリーのうち2つ以上で治療反応がなかった場合、参加者は除外されます。

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：DBT リメゲパント/OLE リメゲパント

DBT フェーズ (第 1 週から第 12 週): 参加者は、12 週間、rimegepant 口腔内崩壊錠 (ODT) EOD の単回経口投与を受けます。

OLE フェーズ (第 13 週から第 24 週): 引き続き試験参加基準を満たしている参加者は、OLE フェーズに入り、12 週間、rimegepant ODT EOD の単回経口投与を受けます。 参加者が、rimegepant を投与する予定がない日に片頭痛を発症した場合は、その暦日に rimegepant ODT を 1 錠服用して片頭痛を治療することができます (必要に応じて [PRN] 投与)。
薬：リメゲパント
リメゲパント
他の名前：
  • PF-07899801、BHV-3000
プラセボコンパレーター：DBT プラセボ/OLE リメゲパント

DBT フェーズ (第 1 週から第 12 週): 参加者は、rimegepant ODT EOD に一致するプラセボの単回経口投与を 12 週間受けます。

OLE フェーズ (第 13 週から第 24 週): 引き続き試験参加基準を満たしている参加者は、OLE フェーズに入り、12 週間、rimegepant ODT EOD の単回経口投与を受けます。 参加者が、rimegepant を投与する予定のない日に片頭痛がある場合は、その暦日に rimegepant ODT を 1 錠服用して片頭痛を治療することができます (PRN 投与)。
薬：プラセボ
一致するプラセボ
薬：リメゲパント
リメゲパント
他の名前：
  • PF-07899801、BHV-3000

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年5月15日

一次修了 (実際)

2025年8月25日

研究の完了 (実際)

2025年12月10日

試験登録日

最初に提出

2023年3月30日

QC基準を満たした最初の提出物

2023年3月30日

最初の投稿 (実際)

2023年4月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月3日

QC基準を満たした最後の更新が送信されました

2026年8月12日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • C4951019 (Alias Study Number)
  • BHV3000-319 (その他の識別子：Alias Study Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

ファイザーは、匿名化された個々の参加者データおよび関連する研究文書へのアクセスを提供します (例: プロトコル、統計分析計画 (SAP)、臨床研究報告書 (CSR)) は、有資格の研究者からの要求に応じて、特定の基準、条件、および例外に従います。 ファイザーのデータ共有基準とアクセス要求プロセスの詳細については、https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests をご覧ください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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