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En studie for å lære om sikkerheten og effekten av Rimegepant for å forhindre migrene hos kinesiske fag.

12. august 2026 oppdatert av: Pfizer

En fase 3, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Rimegepant for migreneforebygging hos kinesiske deltakere

Hensikten med denne studien er å lære om effekten av Rimegepant for å forhindre migrene.

Denne studien søker etter deltakere som:

  • Er mann og kvinne på 18 år eller eldre.
  • Har minst 1 års historie med migrene.
  • Tok ingen medisiner mot migrene før starten av denne studien. Studien vil pågå i rundt 30 uker, inkludert 4 faser og 11 besøk. Deltakere som velges ut til studien vil bli tilfeldig fordelt i behandlingsgrupper. Deretter vil deltakerne gå inn i en 12-ukers Double-blind Treatment (DBT) fase. Etter å ha fullført DBT-fasen, kan noen utvalgte deltakere gå inn i en 12-ukers Open-label Extension (OLE) fase. Deltakerne vil komme tilbake til studiestedet på slutten av uke 24 for slutten av behandling (EOT)-besøk. Det vil være en oppfølging uke 2-besøk rundt 14 dager etter EOT-besøket.

Deltakerne vil bli bedt om å ta 1 tablett studiemedisin annenhver kalenderdag. Dette må følges uavhengig av om de har migrene den dagen eller ikke. Kun i løpet av OLE-fasen, hvis en deltaker har migrene på en ikke-planlagt doseringsdag, kan de ta 1 tablett Rimegepant oralt disintegrerende tablett (ODT) som akutt behandling for migrene, om nødvendig, med maksimalt 1 tablett Rimegepant per kalenderdag. Studieteamet vil se på hvordan hver enkelt deltaker har det med studiebehandlingen under de vanlige besøkene på studieklinikken.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

787

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

1. Målpopulasjon: Deltakeren har minst 1 års historie med migrene (med eller uten aura) i samsvar med en diagnose i henhold til International Classification of Headache Disorders, 3. utgave, inkludert følgende:

  1. Alder for debut av migrene før 50 år
  2. Migreneanfall varer i gjennomsnitt 4 til 72 timer hvis de ikke behandles
  3. Per deltakerrapport, 4 til 18 migreneanfall av moderat eller alvorlig intensitet per måned i løpet av de siste 3 månedene før screeningbesøket (måned er definert som 4 uker for formålet med denne protokollen)
  4. 6 eller flere migrenedager under observasjonsfasen
  5. Ikke mer enn 18 dager med hodepine i observasjonsfasen
  6. Evne til å skille migreneanfall fra spenning/clusterhodepine.
  7. Deltakere med kontraindikasjoner for bruk av triptaner kan inkluderes forutsatt at de oppfyller alle andre kriterier for studiestart.

Ekskluderingskriterier:

  1. Deltakeren har en historie med basilar migrene eller hemiplegisk migrene.
  2. Deltakere med hodepine som oppstår 19 eller flere dager per måned (migrene eller ikke-migrene) i en av de 3 månedene før screeningbesøket.
  3. Deltakere ekskluderes hvis de ikke har hatt noen terapeutisk respons med > 2 av de 9 medikamentkategoriene for forebyggende behandling av migrene etter en adekvat terapeutisk utprøving i løpet av de siste 3 årene i henhold til etterforskerens vurdering.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DBT Rimegepant/OLE Rimegepant

DBT-fase (uke 1 til 12): Deltakerne vil motta en enkelt oral dose av rimegepant oral disintegration tablet (ODT) EOD i 12 uker.

OLE-fase (uke 13 til og med 24): Deltakere som fortsetter å oppfylle kriteriene for studiestart, vil gå inn i OLE-fasen og motta en enkelt oral dose av rimegepant ODT EOD i 12 uker. Hvis deltakerne har migrene på en dag de ikke er planlagt å dosere med rimegepant, kan de ta en tablett rimegepant ODT på den kalenderdagen for å behandle en migrene (etter behov [PRN]-dosering).
Legemiddel: Rimegepant
Rimegepant
Andre navn:
  • PF-07899801, BHV-3000
Placebo komparator: DBT Placebo/OLE Rimegepant

DBT-fase (uke 1 til og med 12): Deltakerne vil motta en enkelt oral dose placebo som matcher rimegepant ODT EOD i 12 uker.

OLE-fase (uke 13 til og med 24): Deltakere som fortsetter å oppfylle kriteriene for studiestart, vil gå inn i OLE-fasen og motta en enkelt oral dose av rimegepant ODT EOD i 12 uker. Hvis deltakerne har migrene på en dag de ikke er planlagt å dosere med rimegepant, kan de ta en tablett rimegepant ODT på den kalenderdagen for å behandle en migrene (PRN-dosering).
Legemiddel: Placebo
matchende placebo
Legemiddel: Rimegepant
Rimegepant
Andre navn:
  • PF-07899801, BHV-3000

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. mai 2023

Primær fullføring (Faktiske)

25. august 2025

Studiet fullført (Faktiske)

10. desember 2025

Datoer for studieregistrering

Først innsendt

30. mars 2023

Først innsendt som oppfylte QC-kriteriene

30. mars 2023

Først lagt ut (Faktiske)

12. april 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C4951019 (Alias Study Number)
  • BHV3000-319 (Annen identifikator: Alias Study Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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