Cresemba® v léčbě čínských pacientů s IFD způsobenou druhy Aspergillus nebo jinými vláknitými houbami
26. května 2026 aktualizováno: Pfizer
JEDNORAZOVÁ, PROSPEKTIVNÍ, MULTICENTRICKÁ STUDIE K HODNOCENÍ BEZPEČNOSTI A ÚČINNOSTI ISAVUKONAZOLE PRO PRIMÁRNÍ LÉČBU ČÍNSKÝCH PACIENTŮ S INVAZIVNÍM PLÍBOVÝM ONEMOCNĚNÍM (IFD) ZPŮSOBENÝM DRUHY ASPERGILLUS NEBO JINÝMI FUNGILA
Tato studie je závaznou studií po schválení a je navržena tak, aby dále vyhodnotila bezpečnost a účinnost isavukonazolu u relativně větší čínské populace, která bude po uvedení na trh dostávat léčbu isavukonazolem.
Jedná se o jednoramennou, prospektivní, multicentrickou studii. Tato studie hledá čínské pacienty s prokázanou, pravděpodobnou nebo možnou invazivní houbovou chorobou (IFD) způsobenou druhem Aspergillus nebo jinými vláknitými houbami. Všichni účastníci budou léčeni isavukonazolem. Nejdelší doba léčby v této studii je 84 dní (až 180 dní u účastníků s diagnózou IM).
Primárním cílem je charakterizovat bezpečnost a snášenlivost isavukonazolu prostřednictvím sledování nežádoucích účinků souvisejících s léčbou.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
70
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Beijing, Čína, 100044
- Peking University People's Hospital
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Bengbu, Čína, 233000
- The First Affiliated Hospital of Bengbu Medical College
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Shanghai, Čína, 201800
- Jiading Central Hospital
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Anhui
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Hefei, Anhui, Čína, 230001
- The First Affiliated Hospital of USTC, Anhui Province Hospital
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Guangdong
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Guangzhou, Guangdong, Čína, 510180
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, Čína, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Čína, 510280
- Zhujiang Hospital of Southern Medical University
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Jieyang, Guangdong, Čína, 522095
- Jieyang People's Hospital
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Henan
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Zhengzhou, Henan, Čína, 450003
- Henan Provincial People's Hospital
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Shandong
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Liaocheng, Shandong, Čína, 252000
- Liaocheng people's Hospital
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Zibo, Shandong, Čína, 255036
- Zibo Central Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200040
- Huashan Hospital, Fudan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Čína, 300020
- Institute of Hematology, Chinese Academy of Medical Sciences
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310003
- The First Affiliated Hospital Zhejiang University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- prokázaná, pravděpodobná nebo možná IFD způsobená druhy Aspergillus, Mucorales nebo jinými vláknitými houbami
- tělesná hmotnost > 40 kg při screeningu
Kritéria vyloučení:
- buď chronická aspergilóza, aspergilom nebo ABPA
- Pokročilá infekce HIV s počtem CD4 < 200 nebo stav definující syndrom získané imunodeficience
- lidé, kteří pravděpodobně nepřežijí 5 dní nebo účastníci na mechanické ventilaci
- těžké poškození jater (Child-Pugh třída C)
- familiární syndrom krátkého QT intervalu
- Současné užívání efavirenzu, ritonaviru, etravirinu, rifampicinu/rifampinu, rifabutinu, nafcilinu, ketokonazolu nebo třezalky tečkované během 5 dnů před prvním podáním studijní intervence
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Isavukonazol
Toto je jednoramenná studie, všichni zařazení účastníci dostanou studijní medikaci.
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Jedná se o jednoramennou studii, všichni zapsaní účastníci obdrží studijní intervenci.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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All-cause Mortality Rate Through Day 42
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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 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)
Časové okno: 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 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
Časové okno: 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 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
Časové okno: 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 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
7. února 2023
Primární dokončení (Aktuální)
11. dubna 2025
Dokončení studie (Aktuální)
11. dubna 2025
Termíny zápisu do studia
První předloženo
18. listopadu 2022
První předloženo, které splnilo kritéria kontroly kvality
18. listopadu 2022
První zveřejněno (Aktuální)
30. listopadu 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C3791001
- NCT05630976 (Identifikátor registru: ClinicalTrials.gov)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Společnost Pfizer poskytne přístup k jednotlivým neidentifikovaným údajům účastníků a souvisejícím studijním dokumentům (např.
protokol, plán statistické analýzy (SAP), zprávu o klinické studii (CSR)) na žádost kvalifikovaných výzkumných pracovníků a za určitých kritérií, podmínek a výjimek.
Další podrobnosti o kritériích sdílení dat společnosti Pfizer a procesu žádosti o přístup naleznete na adrese: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .