Cresemba® nel trattamento di pazienti cinesi con IFD causata da specie di Aspergillus o altri funghi filamentosi
26 maggio 2026 aggiornato da: Pfizer
UNO STUDIO A BRACCIO SINGOLO, PROSPETTIVO, MULTICENTRICO PER VALUTARE LA SICUREZZA E L'EFFICACIA DI ISAVUCONAZOLO PER IL TRATTAMENTO PRIMARIO DI PAZIENTI CINESI CON MALATTIA FUNGINA INVASIVA (IFD) CAUSATA DA SPECIE DI ASPERGILLUS O ALTRI FUNGHI FILAMENTOSI
Questo studio è uno studio sull'impegno post-approvazione ed è progettato per valutare ulteriormente la sicurezza e l'efficacia di isavuconazolo in una popolazione cinese relativamente più ampia che riceverà un trattamento con isavuconazolo in un contesto post-marketing.
Questo è uno studio multicentrico, prospettico, a braccio singolo. Questo studio sta cercando pazienti cinesi con malattia fungina invasiva (IFD) provata, probabile o possibile causata da specie di Aspergillus o altri funghi filamentosi. Tutti i partecipanti riceveranno un trattamento con isavuconazolo. La durata del trattamento più lunga in questo studio è di 84 giorni (fino a 180 giorni per i partecipanti con diagnosi di IM).
L'obiettivo primario è quello di caratterizzare la sicurezza e la tollerabilità di isavuconazolo attraverso l'osservazione degli eventi avversi emergenti dal trattamento.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
70
Fase
- Fase 4
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
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Beijing, Cina, 100044
- Peking University People's Hospital
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Bengbu, Cina, 233000
- The First Affiliated Hospital of Bengbu Medical College
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Shanghai, Cina, 201800
- Jiading Central Hospital
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Anhui
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Hefei, Anhui, Cina, 230001
- The First Affiliated Hospital of USTC, Anhui Province Hospital
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Guangdong
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Guangzhou, Guangdong, Cina, 510180
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, Cina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Cina, 510280
- Zhujiang Hospital of Southern Medical University
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Jieyang, Guangdong, Cina, 522095
- Jieyang People's Hospital
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Henan
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Zhengzhou, Henan, Cina, 450003
- Henan Provincial People's Hospital
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Shandong
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Liaocheng, Shandong, Cina, 252000
- Liaocheng people's Hospital
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Zibo, Shandong, Cina, 255036
- Zibo Central Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200040
- Huashan Hospital, Fudan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300020
- Institute of Hematology, Chinese Academy of Medical Sciences
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310003
- The First Affiliated Hospital Zhejiang University
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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
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- provata, probabile o possibile IFD causata da specie Aspergillus, specie Mucorales o altri funghi filamentosi
- peso corporeo >40 kg allo screening
Criteri di esclusione:
- aspergillosi cronica, aspergilloma o ABPA
- Infezione avanzata da HIV con conta dei CD4 < 200 o condizione che definisce la sindrome da immunodeficienza acquisita
- persone che difficilmente sopravviveranno 5 giorni o partecipanti alla ventilazione meccanica
- compromissione epatica grave (Classe C di Child-Pugh)
- sindrome familiare del QT corto
- Uso concomitante di efavirenz, ritonavir, etravirina, rifampicina/rifampicina, rifabutina, nafcillina, ketoconazolo o erba di San Giovanni nei 5 giorni precedenti la prima somministrazione dell'intervento in studio
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: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Isavuconazolo
Questo è uno studio a braccio singolo, tutti i partecipanti iscritti riceveranno il farmaco in studio.
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Questo è uno studio a braccio singolo, tutti i partecipanti iscritti riceveranno l'intervento dello studio.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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All-cause Mortality Rate Through Day 42
Lasso di tempo: After first dose of study intervention (Day 1) through Day 42
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All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42.
All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
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After first dose of study intervention (Day 1) through Day 42
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All-cause Mortality Rate Through Day 84
Lasso di tempo: After first dose of study intervention (Day 1) through Day 84
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All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84.
All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
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After first dose of study intervention (Day 1) through Day 84
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Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 180)
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Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following.
Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(>=) 90 percent (%)improvement from screening,2)>= 50% to less than(<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication.
Overall success rate: percentage of participants with overall success at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 180)
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Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 84)
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Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following.
Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) >= 90 percent (%)improvement from screening, 2)>= 50% to < 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication.
Overall success rate: percentage of participants with overall success at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 84)
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Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 180)
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Clinical response was categorized into: success, failure, and not applicable.
Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings.
Assessment was based on investigator's assessment.
Clinical success rate: percentage of participants with clinical success at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 180)
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Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 84)
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Clinical response was categorized into: success, failure, and not applicable.
Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings.
Assessment was based on investigator's assessment.
Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points.
Clinical success rate: percentage of participants with clinical success at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 84)
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Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 180)
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Mycological response was categorized into: success, failure, and not applicable.
Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit.
Success rate: percentage of participants with successful mycological response at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 180)
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Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before or at Day 84)
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Mycological response was categorized into: success, failure, and not applicable.
Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit.
Success rate: percentage of participants with successful mycological response at specified time points.
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Day 42, Day 84 and EOT (any day before or at Day 84)
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Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Lasso di tempo: Day 42, Day 84 and EOT (any day or at before Day 180)
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Radiological response was categorized into: success, failure, and not applicable.
A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 180).
Success rate: percentage of participants with successful radiological response at specified time points.
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Day 42, Day 84 and EOT (any day or at before Day 180)
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Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Lasso di tempo: Day 42, Day 84 and EOT (any day before Day 84)
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Radiological response was categorized into: success, failure, and not applicable.
A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 84).
Success rate: percentage of participants with successful radiological response at specified time points.
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Day 42, Day 84 and EOT (any day before Day 84)
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Number of Participants With Treatment Related TEAEs
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
Treatment related TEAEs were TEAEs related to study intervention.
AEs included both serious and all non-SAEs.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect.
A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With TEAEs Leading to Study Intervention Discontinuation
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
|
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Number of Participants With TEAEs Leading to Death
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug.
In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Death
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of participants with death due to any cause were reported in this outcome measure.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Laboratory Test Abnormalities
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of <0.8* lower limit of normal (LLN), erythrocytes <0.8* LLN, platelets <0.5* LLN >1.75* upper limit of normal (ULN), leukocytes < 0.6* LLN and > 1.5* ULN, lymphocytes and neutrophils < 0.8* LLN and > 1.2* ULN.
b) Chemistry: bilirubin and direct bilirubin >1.5* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase >3.0* ULN, urea nitrogen, urea and creatinine >1.3* ULN, sodium <0.95* LLN and potassium<0.9*
LLN.
c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase >= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Clinically Significant Abnormalities in Vital Signs
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Vital signs included systolic and diastolic blood pressures and pulse rate.
Clinical significance of vital signs was judged by the investigator.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Predefined ECG criteria of clinical significance: a) heart rate (beats per minute [bpm]): value <40 and value >120; b) PR interval (millisecond [(msec)]: value>280; c) QRS interval (msec): value>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value >500 and new prolongation value >480 or increase >= 60.
Only those pre-defined ECG categories for which non-zero data were available have been reported below.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Number of Participants With Abnormal Eye Examination
Lasso di tempo: From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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The eye examination included visual acuity, confrontational visual field testing and color perception testing.
Any abnormality was assessed by a qualified ophthalmologist.
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From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
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Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Lasso di tempo: Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)
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Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
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Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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)
7 febbraio 2023
Completamento primario (Effettivo)
11 aprile 2025
Completamento dello studio (Effettivo)
11 aprile 2025
Date di iscrizione allo studio
Primo inviato
18 novembre 2022
Primo inviato che soddisfa i criteri di controllo qualità
18 novembre 2022
Primo Inserito (Effettivo)
30 novembre 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C3791001
- NCT05630976 (Identificatore di registro: ClinicalTrials.gov)
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
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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 .