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Een studie om meer te weten te komen over de veiligheid en effecten van Rimegepant om migraine bij Chinese proefpersonen te voorkomen.

12 augustus 2026 bijgewerkt door: Pfizer

Een gerandomiseerde, dubbelblinde, placebogecontroleerde fase 3-studie om de werkzaamheid en veiligheid van Rimegepant voor migrainepreventie bij Chinese deelnemers te evalueren

Het doel van deze studie is om meer te weten te komen over de effecten van Rimegepant om migraine te helpen voorkomen.

Deze studie is op zoek naar deelnemers die:

  • Zijn mannen en vrouwen van 18 jaar of ouder.
  • Minstens 1 jaar migraine hebben gehad.
  • Heeft vóór de start van deze studie geen medicatie voor migraine ingenomen. Het onderzoek duurt ongeveer 30 weken, inclusief 4 fasen en 11 bezoeken. Deelnemers die voor het onderzoek worden geselecteerd, worden willekeurig toegewezen aan behandelingsgroepen. Daarna gaan de deelnemers een dubbelblinde behandelingsfase (DBT) van 12 weken in. Na het beëindigen van de DBT-fase kunnen sommige geselecteerde deelnemers een 12 weken durende Open-label Extension (OLE)-fase ingaan. Deelnemers komen aan het einde van week 24 terug naar de onderzoekslocatie voor het bezoek aan het einde van de behandeling (EOT). Er is een vervolgbezoek in week 2 ongeveer 14 dagen na het EOT-bezoek.

Deelnemers wordt gevraagd om de andere kalenderdag 1 tablet studiegeneesmiddel in te nemen. Dit moet worden gevolgd, ongeacht of ze op die dag migraine hebben of niet. Alleen tijdens de OLE-fase, als een deelnemer migraine heeft op een niet-geplande doseringsdag, mag hij indien nodig 1 tablet Rimegepant oraal desintegrerende tablet (ODT) innemen als acute behandeling van zijn migraine, met een maximum van 1 tablet Rimegepant. Rimegepant per kalenderdag. Het studieteam zal tijdens de reguliere bezoeken aan de studiekliniek kijken hoe het met elke deelnemer gaat met de studiebehandeling.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

787

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • 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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

1. Doelpopulatie: Deelnemer heeft ten minste 1 jaar voorgeschiedenis van migraine (met of zonder aura) in overeenstemming met een diagnose volgens de International Classification of Headache Disorders, 3rd Edition, waaronder de volgende:

  1. Leeftijd waarop migraine begint vóór de leeftijd van 50 jaar
  2. Migraine-aanvallen duren gemiddeld 4 tot 72 uur als ze niet worden behandeld
  3. Per deelnemersrapport, 4 tot 18 migraineaanvallen van matige of ernstige intensiteit per maand in de laatste 3 maanden voorafgaand aan het screeningsbezoek (maand wordt gedefinieerd als 4 weken voor de doeleinden van dit protocol)
  4. 6 of meer migrainedagen tijdens de observatiefase
  5. Niet meer dan 18 hoofdpijndagen tijdens de observatiefase
  6. Vermogen om migraineaanvallen te onderscheiden van spannings-/clusterhoofdpijn.
  7. Deelnemers met contra-indicaties voor het gebruik van triptanen kunnen worden opgenomen op voorwaarde dat ze voldoen aan alle andere toelatingscriteria voor het onderzoek.

Uitsluitingscriteria:

  1. Deelnemer heeft een voorgeschiedenis van basale migraine of hemiplegische migraine.
  2. Deelnemers met hoofdpijn die 19 of meer dagen per maand optrad (migraine of niet-migraine) in een van de 3 maanden voorafgaand aan het screeningsbezoek.
  3. Deelnemers worden uitgesloten als ze geen therapeutische respons hebben gehad met > 2 van de 9 medicatiecategorieën van preventieve behandeling van migraine na een adequate therapeutische proef in de afgelopen 3 jaar volgens het oordeel van de onderzoeker.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: DBT Rimegepant/OLE Rimegepant

DBT-fase (week 1 tot en met 12): deelnemers krijgen een enkele orale dosis rimegepant oraal desintegrerende tablet (ODT) EOD gedurende 12 weken.

OLE-fase (week 13 tot en met 24): Deelnemers die blijven voldoen aan de toelatingscriteria voor het onderzoek, gaan de OLE-fase in en krijgen een enkele orale dosis rimegepant ODT EOD gedurende 12 weken. Als deelnemers migraine hebben op een dag dat ze geen dosis rimegepant hebben gepland, kunnen ze op die kalenderdag één tablet rimegepant ODT innemen om migraine te behandelen (dosering naar behoefte [PRN].
Geneesmiddel: Rimegepant
Rimegepant
Andere namen:
  • PF-07899801, BHV-3000
Placebo-vergelijker: DBT Placebo/OLE Rimegepant

DBT-fase (week 1 tot en met 12): deelnemers krijgen gedurende 12 weken een enkele orale dosis placebo die overeenkomt met rimegepant ODT EOD.

OLE-fase (week 13 tot en met 24): Deelnemers die blijven voldoen aan de toelatingscriteria voor het onderzoek, gaan de OLE-fase in en krijgen een enkele orale dosis rimegepant ODT EOD gedurende 12 weken. Als deelnemers migraine hebben op een dag waarop ze geen dosis rimegepant hebben gepland, kunnen ze op die kalenderdag één tablet rimegepant ODT innemen om migraine te behandelen (PRN-dosering).
Geneesmiddel: Placebo
overeenkomende placebo
Geneesmiddel: Rimegepant
Rimegepant
Andere namen:
  • PF-07899801, BHV-3000

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

  • Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 mei 2023

Primaire voltooiing (Werkelijk)

25 augustus 2025

Studie voltooiing (Werkelijk)

10 december 2025

Studieregistratiedata

Eerst ingediend

30 maart 2023

Eerst ingediend dat voldeed aan de QC-criteria

30 maart 2023

Eerst geplaatst (Werkelijk)

12 april 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Pfizer zal toegang verlenen tot gegevens van individuele geanonimiseerde deelnemers en gerelateerde onderzoeksdocumenten (bijv. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) op verzoek van gekwalificeerde onderzoekers en onder voorbehoud van bepaalde criteria, voorwaarden en uitzonderingen. Meer details over Pfizer's criteria voor het delen van gegevens en het proces voor het aanvragen van toegang zijn te vinden op: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren