Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
Sponsor: Pfizer
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-02-07
Completion Date
2025-04-11
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.
Locations (14)
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