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Eine Studie, um mehr über die Sicherheit und Wirkung von Rimegepant zur Vorbeugung von Migräne bei chinesischen Probanden zu erfahren.

12. August 2026 aktualisiert von: Pfizer

Eine randomisierte, doppelblinde, placebokontrollierte Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Rimegepant zur Migräneprävention bei chinesischen Teilnehmern

Der Zweck dieser Studie ist es, mehr über die Wirkungen von Rimegepant bei der Vorbeugung von Migräne zu erfahren.

Diese Studie sucht Teilnehmer, die:

  • Sind männlich und weiblich ab 18 Jahren.
  • Migräne seit mindestens 1 Jahr.
  • Hatte vor Beginn dieser Studie keine Medikamente gegen Migräne eingenommen. Die Studie wird etwa 30 Wochen dauern, einschließlich 4 Phasen und 11 Visiten. Die für die Studie ausgewählten Teilnehmer werden nach dem Zufallsprinzip den Behandlungsgruppen zugeteilt. Danach treten die Teilnehmer in eine 12-wöchige doppelblinde Behandlungsphase (DBT) ein. Nach Abschluss der DBT-Phase können einige ausgewählte Teilnehmer in eine 12-wöchige Open-Label-Extension-Phase (OLE) eintreten. Die Teilnehmer kommen am Ende von Woche 24 für den Besuch am Ende der Behandlung (EOT) zum Studienzentrum zurück. Etwa 14 Tage nach dem EOT-Besuch findet ein Folgebesuch in Woche 2 statt.

Die Teilnehmer werden gebeten, jeden zweiten Kalendertag 1 Tablette des Studienmedikaments einzunehmen. Dies muss unabhängig davon befolgt werden, ob sie an diesem Tag Migräne haben oder nicht. Nur während der OLE-Phase, wenn ein Teilnehmer an einem nicht planmäßigen Einnahmetag Migräne hat, kann er 1 Tablette Rimegepant oral auflösende Tablette (ODT) als Akutbehandlung für seine Migräne einnehmen, falls erforderlich, mit maximal 1 Tablette Rimegepant pro Kalendertag. Das Studienteam wird bei den regelmäßigen Besuchen in der Studienklinik prüfen, wie es jedem Teilnehmer mit der Studienbehandlung geht.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

787

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

1. Zielpopulation: Der Teilnehmer hat seit mindestens 1 Jahr Migräne (mit oder ohne Aura) im Einklang mit einer Diagnose gemäß der Internationalen Klassifikation von Kopfschmerzerkrankungen, 3. Ausgabe, einschließlich der folgenden:

  1. Alter des Beginns der Migräne vor dem 50. Lebensjahr
  2. Migräneattacken dauern im Durchschnitt 4 bis 72 Stunden, wenn sie nicht behandelt werden
  3. Pro Teilnehmerbericht 4 bis 18 Migräneattacken mittlerer oder schwerer Intensität pro Monat innerhalb der letzten 3 Monate vor dem Screening-Besuch (Monat ist für die Zwecke dieses Protokolls als 4 Wochen definiert)
  4. 6 oder mehr Migränetage während der Beobachtungsphase
  5. Nicht mehr als 18 Kopfschmerztage während der Beobachtungsphase
  6. Fähigkeit, Migräneanfälle von Spannungs-/Clusterkopfschmerzen zu unterscheiden.
  7. Teilnehmer mit Kontraindikationen für die Verwendung von Triptanen können eingeschlossen werden, sofern sie alle anderen Studieneintrittskriterien erfüllen.

Ausschlusskriterien:

  1. Der Teilnehmer hat eine Vorgeschichte von basilarer Migräne oder hemiplegischer Migräne.
  2. Teilnehmer mit Kopfschmerzen, die an 19 oder mehr Tagen pro Monat (Migräne oder Nicht-Migräne) in einem der 3 Monate vor dem Screening-Besuch auftreten.
  3. Teilnehmer werden ausgeschlossen, wenn sie auf > 2 der 9 Medikamentenkategorien zur vorbeugenden Behandlung von Migräne nach einer angemessenen therapeutischen Studie in den letzten 3 Jahren nach Einschätzung des Prüfarztes kein therapeutisches Ansprechen hatten.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: DBT Rimegepant/OLE Rimegepant

DBT-Phase (Wochen 1 bis 12): Die Teilnehmer erhalten 12 Wochen lang eine orale Einzeldosis Rimegepant oral auflösende Tablette (ODT) EOD.

OLE-Phase (Wochen 13 bis 24): Teilnehmer, die weiterhin die Studieneintrittskriterien erfüllen, treten in die OLE-Phase ein und erhalten 12 Wochen lang eine orale Einzeldosis Rimegepant ODT EOD. Wenn Teilnehmer an einem Tag, an dem sie keine Rimegepant-Dosierung planen, eine Migräne haben, können sie an diesem Kalendertag eine Tablette Rimegepant ODT einnehmen, um eine Migräne zu behandeln (Dosierung nach Bedarf [PRN]).
Arzneimittel: Rimegepant
Rimegepant
Andere Namen:
  • PF-07899801, BHV-3000
Placebo-Komparator: DBT Placebo/OLE Rimegepant

DBT-Phase (Wochen 1 bis 12): Die Teilnehmer erhalten 12 Wochen lang eine orale Einzeldosis Placebo, die auf Rimegepant ODT EOD abgestimmt ist.

OLE-Phase (Wochen 13 bis 24): Teilnehmer, die weiterhin die Studieneintrittskriterien erfüllen, treten in die OLE-Phase ein und erhalten 12 Wochen lang eine orale Einzeldosis Rimegepant ODT EOD. Wenn Teilnehmer an einem Tag, an dem sie keine Rimegepant-Dosierung planen, eine Migräne haben, können sie an diesem Kalendertag eine Tablette Rimegepant ODT einnehmen, um eine Migräne zu behandeln (PRN-Dosierung).
Arzneimittel: Placebo
passendes Placebo
Arzneimittel: Rimegepant
Rimegepant
Andere Namen:
  • PF-07899801, BHV-3000

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Ermittler

  • Studienleiter: Pfizer CT.gov Call Center, Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Mai 2023

Primärer Abschluss (Tatsächlich)

25. August 2025

Studienabschluss (Tatsächlich)

10. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

30. März 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2023

Zuerst gepostet (Tatsächlich)

12. April 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • C4951019 (Alias Study Number)
  • BHV3000-319 (Andere Kennung: Alias Study Number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Pfizer gewährt Zugang zu individuellen anonymisierten Teilnehmerdaten und zugehörigen Studiendokumenten (z. Protokoll, statistischer Analyseplan (SAP), klinischer Studienbericht (CSR)) auf Anfrage von qualifizierten Forschern und vorbehaltlich bestimmter Kriterien, Bedingungen und Ausnahmen. Weitere Einzelheiten zu Pfizers Kriterien für die gemeinsame Nutzung von Daten und das Verfahren zur Beantragung des Zugriffs finden Sie unter: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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