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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05630976
Other study ID # C3791001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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