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Uno studio per conoscere la sicurezza e gli effetti di Rimegepant per prevenire l'emicrania nei soggetti cinesi.

12 agosto 2026 aggiornato da: Pfizer

Uno studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Rimegepant per la prevenzione dell'emicrania nei partecipanti cinesi

Lo scopo di questo studio è conoscere gli effetti di Rimegepant per aiutare a prevenire l'emicrania.

Questo studio è alla ricerca di partecipanti che:

  • Sono maschi e femmine di età pari o superiore a 18 anni.
  • Avere almeno 1 anno di storia di emicrania.
  • Non ha assunto alcun farmaco per l'emicrania prima dell'inizio di questo studio. Lo studio andrà avanti per circa 30 settimane, incluse 4 Fasi e 11 Visite. I partecipanti selezionati per lo studio verranno assegnati in modo casuale ai gruppi di trattamento. Dopodiché, i partecipanti entreranno in una fase di trattamento in doppio cieco (DBT) di 12 settimane. Dopo aver terminato la fase DBT, alcuni partecipanti selezionati possono accedere a una fase di estensione in aperto (OLE) di 12 settimane. I partecipanti torneranno al sito dello studio alla fine della settimana 24 per la visita di fine trattamento (EOT). Ci sarà una visita di follow-up della Settimana 2 circa 14 giorni dopo la visita EOT.

Ai partecipanti verrà chiesto di assumere 1 compressa del medicinale oggetto dello studio a giorni alterni. Questo deve essere seguito indipendentemente dal fatto che abbiano o meno un'emicrania quel giorno. Solo durante la fase OLE, se un partecipante soffre di emicrania in un giorno di somministrazione non programmato, può assumere 1 compressa di Rimegepant compressa a disintegrazione orale (ODT) come trattamento acuto per la sua emicrania, se necessario, con un massimo di 1 compressa di Rimegepant per giorno di calendario. Il team dello studio esaminerà come ogni partecipante sta facendo con il trattamento dello studio durante le visite regolari presso la clinica dello studio.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

787

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

1. Popolazione target: il partecipante ha almeno 1 anno di storia di emicrania (con o senza aura) coerente con una diagnosi secondo la classificazione internazionale dei disturbi della cefalea, 3a edizione, incluso quanto segue:

  1. Età di insorgenza dell'emicrania prima dei 50 anni
  2. Gli attacchi di emicrania, in media, durano da 4 a 72 ore se non trattati
  3. Per report dei partecipanti, da 4 a 18 attacchi di emicrania di intensità moderata o grave al mese negli ultimi 3 mesi prima della visita di screening (il mese è definito come 4 settimane ai fini del presente protocollo)
  4. 6 o più giorni di emicrania durante la fase di osservazione
  5. Non più di 18 giorni di mal di testa durante la fase di osservazione
  6. Capacità di distinguere gli attacchi di emicrania dalla cefalea tensiva/a grappolo.
  7. I partecipanti con controindicazioni all'uso di triptani possono essere inclusi a condizione che soddisfino tutti gli altri criteri di ammissione allo studio.

Criteri di esclusione:

  1. - Il partecipante ha una storia di emicrania basilare o emicrania emiplegica.
  2. - Partecipanti con mal di testa che si verificano 19 o più giorni al mese (emicrania o non emicrania) in uno qualsiasi dei 3 mesi precedenti la visita di screening.
  3. I partecipanti sono esclusi se non hanno avuto alcuna risposta terapeutica con> 2 delle 9 categorie di farmaci per il trattamento preventivo dell'emicrania dopo un adeguato studio terapeutico negli ultimi 3 anni secondo il giudizio dello sperimentatore.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: DBT Rimegepant/OLE Rimegepant

Fase DBT (settimane da 1 a 12): i partecipanti riceveranno una singola dose orale di rimegepant compressa a disintegrazione orale (ODT) EOD per 12 settimane.

Fase OLE (settimane da 13 a 24): i partecipanti che continuano a soddisfare i criteri di ammissione allo studio, entreranno nella fase OLE e riceveranno una singola dose orale di rimegepant ODT EOD per 12 settimane. Se i partecipanti hanno un'emicrania in un giorno in cui non è prevista la somministrazione di rimegepant, possono assumere una compressa di rimegepant ODT in quel giorno di calendario per trattare un'emicrania (dosaggio secondo necessità [PRN]).
Droga: Rimegepant
Rimegepant
Altri nomi:
  • PF-07899801, BHV-3000
Comparatore placebo: DBT Placebo/OLE Rimegepant

Fase DBT (settimane da 1 a 12): i partecipanti riceveranno una singola dose orale di placebo corrispondente a rimegepant ODT EOD per 12 settimane.

Fase OLE (settimane da 13 a 24): i partecipanti che continuano a soddisfare i criteri di ammissione allo studio, entreranno nella fase OLE e riceveranno una singola dose orale di rimegepant ODT EOD per 12 settimane. Se i partecipanti hanno un'emicrania in un giorno in cui non è prevista la somministrazione di rimegepant, possono assumere una compressa di rimegepant ODT in quel giorno di calendario per trattare un'emicrania (dosaggio PRN).
Droga: Placebo
placebo corrispondente
Droga: Rimegepant
Rimegepant
Altri nomi:
  • PF-07899801, BHV-3000

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Investigatori

  • Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2023

Completamento primario (Effettivo)

25 agosto 2025

Completamento dello studio (Effettivo)

10 dicembre 2025

Date di iscrizione allo studio

Primo inviato

30 marzo 2023

Primo inviato che soddisfa i criteri di controllo qualità

30 marzo 2023

Primo Inserito (Effettivo)

12 aprile 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C4951019 (Alias Study Number)
  • BHV3000-319 (Altro identificatore: Alias Study Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Pfizer fornirà l'accesso ai dati dei singoli partecipanti anonimi e ai relativi documenti di studio (ad es. protocollo, piano di analisi statistica (SAP), rapporto di studio clinico (CSR)) su richiesta di ricercatori qualificati e soggetti a determinati criteri, condizioni ed eccezioni. Ulteriori dettagli sui criteri di condivisione dei dati di Pfizer e sul processo di richiesta di accesso sono disponibili all'indirizzo: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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