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Un estudio para conocer la seguridad y los efectos del rimegepant para prevenir la migraña en sujetos chinos.

12 de agosto de 2026 actualizado por: Pfizer

Un estudio de fase 3, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de rimegepant para la prevención de la migraña en participantes chinos

El propósito de este estudio es conocer los efectos de Rimegepant para ayudar a prevenir la migraña.

Este estudio busca participantes que:

  • Son hombres y mujeres de 18 años de edad o más.
  • Tener al menos 1 año de historia de migraña.
  • No tomó ningún medicamento para la migraña antes del inicio de este estudio. El estudio durará alrededor de 30 semanas, incluidas 4 fases y 11 visitas. Los participantes seleccionados para el estudio serán asignados aleatoriamente a grupos de tratamiento. Después de lo cual, los participantes entrarán en una fase de tratamiento doble ciego (DBT) de 12 semanas. Después de terminar la fase DBT, algunos participantes seleccionados pueden ingresar a una fase de extensión de etiqueta abierta (OLE) de 12 semanas. Los participantes regresarán al sitio de estudio al final de la semana 24 para la visita de fin de tratamiento (EOT). Habrá una visita de seguimiento de la Semana 2 alrededor de 14 días después de la visita EOT.

Se les pedirá a los participantes que tomen 1 tableta del medicamento del estudio cada dos días calendario. Esto debe seguirse independientemente de si tienen migraña ese día o no. Solo durante la Fase OLE, si un participante tiene migraña en un día de dosificación no programado, puede tomar 1 tableta de Rimegepant en tabletas de desintegración oral (ODT) como tratamiento agudo para su migraña, si es necesario, con un máximo de 1 tableta de Rimegepant por día natural. El equipo del estudio observará cómo le está yendo a cada participante con el tratamiento del estudio durante las visitas regulares a la clínica del estudio.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

787

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

1.Población objetivo: el participante tiene al menos 1 año de historia de migraña (con o sin aura) compatible con un diagnóstico según la Clasificación Internacional de Trastornos por Cefalea, 3.ª edición, que incluye lo siguiente:

  1. Edad de inicio de las migrañas antes de los 50 años
  2. Ataques de migraña, en promedio, que duran de 4 a 72 horas si no se tratan
  3. Por informe de participante, de 4 a 18 ataques de migraña de intensidad moderada o grave por mes en los últimos 3 meses antes de la visita de selección (el mes se define como 4 semanas a los fines de este protocolo)
  4. 6 o más días de migraña durante la fase de observación
  5. No más de 18 días de dolor de cabeza durante la Fase de Observación
  6. Capacidad para distinguir los ataques de migraña de las cefaleas tensionales/en racimos.
  7. Se pueden incluir participantes con contraindicaciones para el uso de triptanes siempre que cumplan con todos los demás criterios de ingreso al estudio.

Criterio de exclusión:

  1. El participante tiene antecedentes de migraña basilar o migraña hemipléjica.
  2. Participantes con dolores de cabeza que ocurren 19 o más días por mes (migraña o sin migraña) en cualquiera de los 3 meses anteriores a la visita de selección.
  3. Se excluyen los participantes si no han tenido respuesta terapéutica con > 2 de las 9 categorías de medicamentos del tratamiento preventivo de la migraña después de un ensayo terapéutico adecuado en los últimos 3 años según el criterio del investigador.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rimegepant DBT/Rimegepant OLE

Fase de DBT (semanas 1 a 12): los participantes recibirán una dosis oral única de EOD en tabletas de desintegración oral (ODT) de rimegepant durante 12 semanas.

Fase OLE (semanas 13 a 24): los participantes que continúen cumpliendo con los criterios de ingreso al estudio, ingresarán a la fase OLE y recibirán una dosis oral única de rimegepant ODT EOD durante 12 semanas. Si los participantes tienen migraña en un día en el que no tienen programada la dosis de rimegepant, pueden tomar una tableta de rimegepant ODT en ese día calendario para tratar la migraña (según la dosificación necesaria [PRN]).
Droga: Rimegepant
Rimegepant
Otros nombres:
  • PF-07899801, BHV-3000
Comparador de placebos: DBT Placebo/OLE Rimegepant

Fase DBT (semanas 1 a 12): los participantes recibirán una dosis oral única de placebo equivalente a rimegepant ODT EOD durante 12 semanas.

Fase OLE (semanas 13 a 24): los participantes que continúen cumpliendo con los criterios de ingreso al estudio, ingresarán a la fase OLE y recibirán una dosis oral única de rimegepant ODT EOD durante 12 semanas. Si los participantes tienen migraña en un día en el que no tienen programada la dosis de rimegepant, pueden tomar una tableta de rimegepant ODT en ese día calendario para tratar la migraña (dosificación PRN).
Droga: Placebo
placebo coincidente
Droga: Rimegepant
Rimegepant
Otros nombres:
  • PF-07899801, BHV-3000

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Investigadores

  • Director de estudio: Pfizer CT.gov Call Center, Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de mayo de 2023

Finalización primaria (Actual)

25 de agosto de 2025

Finalización del estudio (Actual)

10 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

30 de marzo de 2023

Primero enviado que cumplió con los criterios de control de calidad

30 de marzo de 2023

Publicado por primera vez (Actual)

12 de abril de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C4951019 (Alias Study Number)
  • BHV3000-319 (Otro identificador: Alias Study Number)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Pfizer brindará acceso a los datos individuales de los participantes anonimizados y a los documentos del estudio relacionados (p. protocolo, Plan de Análisis Estadístico (SAP), Informe de Estudio Clínico (CSR)) a solicitud de investigadores calificados, y sujeto a ciertos criterios, condiciones y excepciones. Se pueden encontrar más detalles sobre los criterios de intercambio de datos de Pfizer y el proceso para solicitar acceso en: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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