Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
NCT ID: NCT05630976
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2023-02-07
2025-04-11
Brief Summary
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This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM).
The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Isavuconazole
This is a single arm study, all enrolled participants will receive the study medication.
Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.
Interventions
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Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* body weight \>40 kg at screening
Exclusion Criteria
* Advanced HIV infection with CD4 count \< 200 or acquired immunodeficiency syndrome-defining condition
* people who are unlikely to survive 5 days or participants on mechanical ventilation
* severe hepatic impairment (Child-Pugh Class C)
* familial short QT syndrome
* Concomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or St. John's Wort in the 5 days prior to first administration of study intervention
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The First Affiliated Hospital of USTC, Anhui Province Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Henan provincial people's hospital
Zhengzhou, Henan, China
Liaocheng people's Hospital
Liaocheng, Shandong, China
Zibo Central Hospital
Zibo, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
Peking University People's Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Jiading Central Hospital
Shanghai, , China
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05630976
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3791001
Identifier Type: -
Identifier Source: org_study_id
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