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

Invasive Fungal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630976
• Other study ID #: C3791001
• Status: Recruiting
• Phase: Phase 4
• Start date: February 7, 2023
• Est. completion date: June 27, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi

• body weight >40 kg at screening

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Invasive Fungal Disease
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Isavuconazole
This is a single arm study, all enrolled participants will receive the study intervention.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital Zhejiang University	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of USTC, Anhui Province Hospital	Hefei	Anhui
China	Jieyang People's Hospital	Jieyang	Guangdong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Liaocheng people's Hospital	Liaocheng	Shandong
China	Liaocheng people's Hospital	Liaocheng	Shandong
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Jiading Central Hospital	Shanghai
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	Institute of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Henan provincial people's hospital	Zhengzhou	Henan
China	Zibo Central Hospital	Zibo	Shandong
China	Zibo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of all-cause mortality following primary treatment with isavuconazole.		Day 42 and Day 84
Secondary	Crude rate of overall response at EOT	Responses based on the investigators' assessment at EOT	Day 42, and 84
Secondary	Crude rate of success of the clinical response at EOT	Responses based on the investigators' assessment at EOT	Day 42, and 84
Secondary	Crude rate of success of the mycological response at EOT	Responses based on the investigators' assessment at EOT	Day 42, and 84
Secondary	Crude rate success of the radiological responses at EOT	Responses based on the investigators' assessment at EOT	Day 42, and 84
Secondary	Number of Participants with TEAEs related to study intervention		Day 42, and 84
Secondary	Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention		Day 42, and 84
Secondary	Number of Participants with TEAE leading to discontinuation of study intervention		Day 42, and 84
Secondary	Number of Participants with TEAE leading to deaths		Day 42, and 84
Secondary	Number of all deaths		Day 42, and 84
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Day 42, and 84
Secondary	Number of Participants with Vital Signs Abnormalities		Day 42, and 84
Secondary	Number of Participants with Abnormal Electrocardiogram (ECG)		Day 42, and 84
Secondary	Number of Participants with Abnormal Eye Examination.		Day 42, and 84
Secondary	Isavuconazole plasma concentration		Day 3, 7, 14, and EOT visit

External Links

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