Cresemba® kiinalaisten potilaiden hoidossa, joilla on Aspergillus-lajin tai muiden rihmasienten aiheuttama IFD
tiistai 26. toukokuuta 2026 päivittänyt: Pfizer
YHDEN KÄSIN, ULKOINEN, MONEN KESKUKSEN TUTKIMUS ISAVUKONATSOLIN TURVALLISUUDEN JA TEHOKKUUDEN ARVIOIMISEKSI ASPERGILLUS FILAO SPEKTIUN AIHEUTTAMAAN KIINALAISILLE POTILAILILLE, SAADAAN INVASIIVISTA SIENITAUTIA (IFD)
Tämä tutkimus on hyväksynnän jälkeinen sitoutumistutkimus, ja sen tarkoituksena on arvioida edelleen isavukonatsolin turvallisuutta ja tehoa suhteellisen suuremmassa kiinalaisessa väestössä, joka saa isavukonatsolihoitoa markkinoille tulon jälkeen.
Tämä on yksihaarainen, tulevaisuuden monikeskustutkimus. Tähän tutkimukseen etsitään kiinalaisia potilaita, joilla on todistetusti, todennäköinen tai mahdollinen Aspergillus-lajin tai muiden rihmasienten aiheuttama invasiivinen sienitauti (IFD). Kaikki osallistujat saavat isavukonatsolihoitoa. Pisin hoidon kesto tässä tutkimuksessa on 84 päivää (jopa 180 päivää osallistujille, joilla on diagnosoitu IM).
Ensisijainen tavoite on karakterisoida isavukonatsolin turvallisuutta ja siedettävyyttä tarkkailemalla hoidosta aiheutuvia haittavaikutuksia.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
70
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Beijing, Kiina, 100044
- Peking University People's Hospital
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Bengbu, Kiina, 233000
- the First Affiliated Hospital of Bengbu Medical College
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Shanghai, Kiina, 201800
- Jiading Central Hospital
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Anhui
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Hefei, Anhui, Kiina, 230001
- The First Affiliated Hospital of USTC, Anhui Province Hospital
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Guangdong
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Guangzhou, Guangdong, Kiina, 510180
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, Kiina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, Kiina, 510280
- ZhuJiang Hospital of Southern Medical University
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Jieyang, Guangdong, Kiina, 522095
- Jieyang People's Hospital
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Henan
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Zhengzhou, Henan, Kiina, 450003
- Henan Provincial People's Hospital
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Shandong
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Liaocheng, Shandong, Kiina, 252000
- Liaocheng People's Hospital
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Zibo, Shandong, Kiina, 255036
- Zibo Central Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 200040
- Huashan Hospital, Fudan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kiina, 300020
- Institute of Hematology, Chinese Academy of Medical Sciences
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Zhejiang
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Hangzhou, Zhejiang, Kiina, 310003
- The First Affiliated Hospital Zhejiang University
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- todistettu, todennäköinen tai mahdollinen Aspergillus-, Mucorales- tai muiden rihmasienten aiheuttama IFD
- ruumiinpaino yli 40 kg seulonnassa
Poissulkemiskriteerit:
- joko krooninen aspergilloosi, aspergillooma tai ABPA
- Pitkälle edennyt HIV-infektio, jonka CD4-määrä on < 200, tai hankinnainen immuunikatooireyhtymä määrittelevä tila
- ihmiset, jotka eivät todennäköisesti selviä hengissä 5 päivää tai osallistujat koneelliseen ventilaatioon
- vaikea maksan vajaatoiminta (Child-Pugh-luokka C)
- familiaalinen lyhyt QT-oireyhtymä
- Efavirentsin, ritonaviirin, etraviriinin, rifampisiinin/rifampiinin, rifabutiinin, nafsilliinin, ketokonatsolin tai mäkikuisman samanaikainen käyttö 5 päivän aikana ennen ensimmäistä tutkimustoimenpidettä
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Isavukonatsoli
Tämä on yhden käden tutkimus, kaikki osallistujat saavat tutkimuslääkkeen.
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Tämä on yhden käden tutkimus, kaikki osallistujat saavat tutkimusintervention.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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All-cause Mortality Rate Through Day 42
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
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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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
|
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Number of Participants With TEAEs Leading to Death
Aikaikkuna: 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)
|
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Number of Participants With Death
Aikaikkuna: 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.
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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
Aikaikkuna: 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
Aikaikkuna: 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.
|
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Pfizer CT.gov Call Center, Pfizer
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
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Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 30. marraskuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C3791001
- NCT05630976 (Rekisterin tunniste: ClinicalTrials.gov)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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JOO
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protokolla, tilastollinen analyysisuunnitelma (SAP), kliininen tutkimusraportti (CSR)) pätevien tutkijoiden pyynnöstä ja tietyin kriteerein, ehdoin ja poikkeuksin.
Lisätietoja Pfizerin tietojen jakamiskriteereistä ja käyttöoikeuden pyytämisprosessista on osoitteessa https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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