Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI
2 other identifiers
interventional
70
1 country
14
Brief Summary
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2023
Typical duration for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2022
CompletedFirst Posted
Study publicly available on registry
November 30, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2025
CompletedJuly 10, 2025
July 1, 2025
2.2 years
November 18, 2022
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
From Baseline to End of Study (EOS) and Prothrombin Time (PT)
Secondary Outcomes (15)
Percentage of all-cause mortality following primary treatment with isavuconazole.
Day 42 and Day 84
Crude rate of overall response at EOT
Day 42, and 84
Crude rate of success of the clinical response at EOT
Day 42, and 84
Crude rate of success of the mycological response at EOT
Day 42, and 84
Crude rate success of the radiological responses at EOT
Day 42, and 84
- +10 more secondary outcomes
Study Arms (1)
Isavuconazole
EXPERIMENTALThis is a single arm study, all enrolled participants will receive the study medication.
Interventions
This is a single arm study, all enrolled participants will receive the study intervention.
Eligibility Criteria
You may qualify if:
- proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
- body weight \>40 kg at screening
You may not qualify if:
- either chronic aspergillosis, aspergilloma, or ABPA
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (14)
The First Affiliated Hospital of USTC, Anhui Province Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Jieyang People's Hospital
Jieyang, Guangdong, 522095, China
Henan provincial people's hospital
Zhengzhou, Henan, 450003, China
Liaocheng people's Hospital
Liaocheng, Shandong, 252000, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, 310003, China
Peking University People's Hospital
Beijing, 100044, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000, China
Jiading Central Hospital
Shanghai, 201800, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2022
First Posted
November 30, 2022
Study Start
February 7, 2023
Primary Completion
April 11, 2025
Study Completion
April 11, 2025
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.