Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05630976
PHASE4

Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

DRUG

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