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Cresemba® til behandling af kinesiske patienter med IFD forårsaget af Aspergillus-arter eller andre filamentøse svampe

26. maj 2026 opdateret af: Pfizer

EN ENEARMET, PROSPEKTIV, MULTI-CENTER STUDIE TIL EVALUERING AF SIKKERHED OG EFFEKTIVITET AF ISAVUCONAZOL TIL PRIMÆR BEHANDLING AF KINESISKE PATIENTER MED INVASIV SVAMPESYGDOM (IFD) FORÅRSAGET AF ASPERGILLUS ANDRE ARTER.

Dette studie er et forpligtelsesstudie efter godkendelse og er designet til yderligere at evaluere sikkerheden og effektiviteten af ​​isavuconazol i en relativt større kinesisk befolkning, som vil modtage isavuconazolbehandling efter markedsføring.

Dette er en enarms, prospektiv, multi-center undersøgelse. Denne undersøgelse søger kinesiske patienter med påvist, sandsynlig eller mulig invasiv svampesygdom (IFD) forårsaget af Aspergillus-arter eller andre filamentøse svampe. Alle deltagere vil modtage isavuconazolbehandling. Den længste behandlingsvarighed i denne undersøgelse er 84 dage (op til 180 dage for deltagere diagnosticeret med IM).

Det primære formål er at karakterisere sikkerheden og tolerabiliteten af ​​isavuconazol gennem observation af behandlingens opståede bivirkninger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100044
        • Peking University People's Hospital
      • Bengbu, Kina, 233000
        • The First Affiliated Hospital of Bengbu Medical College
      • Shanghai, Kina, 201800
        • Jiading Central Hospital
    • Anhui
      • Hefei, Anhui, Kina, 230001
        • The First Affiliated Hospital of USTC, Anhui Province Hospital
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, Kina, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, Kina, 510280
        • Zhujiang Hospital of Southern Medical University
      • Jieyang, Guangdong, Kina, 522095
        • Jieyang People's Hospital
    • Henan
      • Zhengzhou, Henan, Kina, 450003
        • Henan Provincial People's Hospital
    • Shandong
      • Liaocheng, Shandong, Kina, 252000
        • Liaocheng people's Hospital
      • Zibo, Shandong, Kina, 255036
        • Zibo Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Huashan Hospital, Fudan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300020
        • Institute of Hematology, Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • The First Affiliated Hospital Zhejiang University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • bevist, sandsynlig eller mulig IFD forårsaget af Aspergillus-arter, Mucorales-arter eller andre filamentøse svampe
  • kropsvægt >40 kg ved screening

Ekskluderingskriterier:

  • enten kronisk aspergillose, aspergilloma eller ABPA
  • Avanceret HIV-infektion med CD4-tal < 200 eller erhvervet immundefektsyndrom-definerende tilstand
  • personer, der sandsynligvis ikke overlever 5 dage eller deltagere på mekanisk ventilation
  • alvorligt nedsat leverfunktion (Child-Pugh klasse C)
  • familiært kort QT-syndrom
  • Samtidig brug af efavirenz, ritonavir, etravirin, rifampicin/rifampin, rifabutin, nafcillin, ketoconazol eller perikon i de 5 dage før første administration af undersøgelsesintervention

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Isavuconazol
Dette er en enkeltarmsundersøgelse, alle tilmeldte deltagere vil modtage undersøgelsesmedicinen.
Medicin: Isavuconazol
Dette er en enkeltarmsundersøgelse, alle tilmeldte deltagere vil modtage undersøgelsesinterventionen.
Andre navne:
  • Cresemba®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: 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 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).
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause Mortality Rate Through Day 42
Tidsramme: After first dose of study intervention (Day 1) through Day 42
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.
After first dose of study intervention (Day 1) through Day 42
All-cause Mortality Rate Through Day 84
Tidsramme: After first dose of study intervention (Day 1) through Day 84
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.
After first dose of study intervention (Day 1) through Day 84
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 180)
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.
Day 42, Day 84 and EOT (any day before or at Day 180)
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 84)
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.
Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 180)
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.
Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 84)
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.
Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 180)
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.
Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Tidsramme: Day 42, Day 84 and EOT (any day before or at Day 84)
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.
Day 42, Day 84 and EOT (any day before or at Day 84)
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
Tidsramme: Day 42, Day 84 and EOT (any day or at before Day 180)
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.
Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
Tidsramme: Day 42, Day 84 and EOT (any day before Day 84)
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.
Day 42, Day 84 and EOT (any day before Day 84)
Number of Participants With Treatment Related TEAEs
Tidsramme: 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.
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)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Tidsramme: 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.
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)
Number of Participants With TEAEs Leading to Study Intervention Discontinuation
Tidsramme: 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.
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)
Number of Participants With TEAEs Leading to Death
Tidsramme: 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.
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)
Number of Participants With Death
Tidsramme: 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)
Number of participants with death due to any cause were reported in this outcome measure.
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)
Number of Participants With Laboratory Test Abnormalities
Tidsramme: 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)
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.
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)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Tidsramme: 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)
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
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)
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
Tidsramme: 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)
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.
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)
Number of Participants With Abnormal Eye Examination
Tidsramme: 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)
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
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)
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
Tidsramme: 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)
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. februar 2023

Primær færdiggørelse (Faktiske)

11. april 2025

Studieafslutning (Faktiske)

11. april 2025

Datoer for studieregistrering

Først indsendt

18. november 2022

Først indsendt, der opfyldte QC-kriterier

18. november 2022

Først opslået (Faktiske)

30. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C3791001
  • NCT05630976 (Registry Identifier: ClinicalTrials.gov)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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