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Une étude pour en savoir plus sur la sécurité et les effets du Rimegepant pour prévenir la migraine chez les sujets chinois.

12 août 2026 mis à jour par: Pfizer

Une étude de phase 3, randomisée, en double aveugle et contrôlée par placebo pour évaluer l'efficacité et l'innocuité du Rimegepant pour la prévention de la migraine chez les participants chinois

Le but de cette étude est d'en savoir plus sur les effets de Rimegepant pour aider à prévenir la migraine.

Cette étude recherche des participants qui :

  • Sont des hommes et des femmes de 18 ans ou plus.
  • Avoir au moins 1 an d'antécédents de migraine.
  • N'a pris aucun médicament contre la migraine avant le début de cette étude. L'étude durera environ 30 semaines, comprenant 4 phases et 11 visites. Les participants sélectionnés pour l'étude seront assignés au hasard à des groupes de traitement. Après quoi, les participants entreront dans une phase de traitement en double aveugle (DBT) de 12 semaines. Après avoir terminé la phase DBT, certains participants sélectionnés peuvent entrer dans une phase d'extension en ouvert (OLE) de 12 semaines. Les participants reviendront sur le site de l'étude à la fin de la semaine 24 pour la visite de fin de traitement (EOT). Il y aura une visite de suivi de la semaine 2 environ 14 jours après la visite EOT.

Les participants seront invités à prendre 1 comprimé du médicament à l'étude tous les deux jours calendaires. Cela doit être suivi indépendamment du fait qu'ils aient ou non une migraine ce jour-là. Pendant la phase OLE uniquement, si un participant a une migraine un jour de dosage non programmé, il peut prendre 1 comprimé de Rimegepant comprimé à désintégration orale (ODT) comme traitement aigu de sa migraine, si nécessaire, avec un maximum de 1 comprimé de Rimegepant par jour calendaire. L'équipe de l'étude examinera comment chaque participant s'en sort avec le traitement à l'étude lors des visites régulières à la clinique de l'étude.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

787

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

1.Population cible : le participant a au moins 1 an d'antécédents de migraine (avec ou sans aura) compatible avec un diagnostic selon la Classification internationale des maux de tête, 3e édition, y compris les éléments suivants :

  1. Âge de début des migraines avant 50 ans
  2. Crises de migraine, en moyenne, d'une durée de 4 à 72 heures si elles ne sont pas traitées
  3. Par rapport de participant, 4 à 18 crises de migraine d'intensité modérée ou sévère par mois au cours des 3 derniers mois précédant la visite de dépistage (le mois est défini comme 4 semaines aux fins de ce protocole)
  4. 6 jours de migraine ou plus pendant la phase d'observation
  5. Pas plus de 18 jours de maux de tête pendant la phase d'observation
  6. Capacité à distinguer les crises de migraine des céphalées de tension/en grappes.
  7. Les participants présentant des contre-indications à l'utilisation de triptans peuvent être inclus à condition qu'ils répondent à tous les autres critères d'admission à l'étude.

Critère d'exclusion:

  1. Le participant a des antécédents de migraine basilaire ou de migraine hémiplégique.
  2. Participants souffrant de maux de tête survenant 19 jours ou plus par mois (migraine ou non-migraine) au cours des 3 mois précédant la visite de sélection.
  3. Les participants sont exclus s'ils n'ont eu aucune réponse thérapeutique avec > 2 des 9 catégories de médicaments du traitement préventif de la migraine après un essai thérapeutique adéquat au cours des 3 dernières années selon le jugement de l'investigateur.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: DBT Rimegepant/OLE Rimegepant

Phase DBT (semaines 1 à 12) : les participants recevront une dose orale unique de comprimé à désintégration orale de rimegepant (ODT) EOD pendant 12 semaines.

Phase OLE (semaines 13 à 24) : les participants qui continuent de répondre aux critères d'entrée à l'étude entreront dans la phase OLE et recevront une dose orale unique de rimegepant ODT EOD pendant 12 semaines. Si les participants ont une migraine un jour où ils ne sont pas programmés pour prendre du rimegepant, ils peuvent prendre un comprimé de rimegepant ODT ce jour-là pour traiter une migraine (dosage selon les besoins [PRN]).
Médicament: Rimegepant
Rimegepant
Autres noms:
  • PF-07899801, BHV-3000
Comparateur placebo: DBT Placebo/OLE Rimegepant

Phase DBT (semaines 1 à 12) : les participants recevront une dose orale unique de placebo correspondant au rimegepant ODT EOD pendant 12 semaines.

Phase OLE (semaines 13 à 24) : les participants qui continuent de répondre aux critères d'entrée à l'étude entreront dans la phase OLE et recevront une dose orale unique de rimegepant ODT EOD pendant 12 semaines. Si les participants ont une migraine un jour où ils ne sont pas programmés pour prendre du rimegepant, ils peuvent prendre un comprimé de rimegepant ODT ce jour-là pour traiter une migraine (dosage PRN).
Médicament: Placebo
placebo correspondant
Médicament: Rimegepant
Rimegepant
Autres noms:
  • PF-07899801, BHV-3000

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Les enquêteurs

  • Directeur d'études: Pfizer CT.gov Call Center, Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 mai 2023

Achèvement primaire (Réel)

25 août 2025

Achèvement de l'étude (Réel)

10 décembre 2025

Dates d'inscription aux études

Première soumission

30 mars 2023

Première soumission répondant aux critères de contrôle qualité

30 mars 2023

Première publication (Réel)

12 avril 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • C4951019 (Alias Study Number)
  • BHV3000-319 (Autre identifiant: Alias Study Number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Pfizer fournira un accès aux données individuelles des participants anonymisés et aux documents d'étude connexes (par ex. protocole, plan d'analyse statistique (PAS), rapport d'étude clinique (CSR)) sur demande de chercheurs qualifiés, et sous réserve de certains critères, conditions et exceptions. De plus amples détails sur les critères de partage des données de Pfizer et le processus de demande d'accès sont disponibles sur : https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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