Clinical trial NCT05630976: Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Invasive Fungal Disease
Keywords: Isavuconazole
Invasive Aspergillus
Invasive mold
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
timeFrame: From Baseline to End of Study (EOS) and Prothrombin Time (PT)
Secondary outcomes:
measure: Percentage of all-cause mortality following primary treatment with isavuconazole.
timeFrame: Day 42 and Day 84
measure: Crude rate of overall response at EOT
timeFrame: Day 42, and 84
measure: Crude rate of success of the clinical response at EOT
timeFrame: Day 42, and 84
measure: Crude rate of success of the mycological response at EOT
timeFrame: Day 42, and 84
measure: Crude rate success of the radiological responses at EOT
timeFrame: Day 42, and 84
measure: Number of Participants with TEAEs related to study intervention
timeFrame: Day 42, and 84
measure: Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention
timeFrame: Day 42, and 84
measure: Number of Participants with TEAE leading to discontinuation of study intervention
timeFrame: Day 42, and 84
measure: Number of Participants with TEAE leading to deaths
timeFrame: Day 42, and 84
measure: Number of all deaths
timeFrame: Day 42, and 84
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Day 42, and 84
measure: Number of Participants with Vital Signs Abnormalities
timeFrame: Day 42, and 84
measure: Number of Participants with Abnormal Electrocardiogram (ECG)
timeFrame: Day 42, and 84
measure: Number of Participants with Abnormal Eye Examination.
timeFrame: Day 42, and 84
measure: Isavuconazole plasma concentration
timeFrame: Day 3, 7, 14, and EOT visit
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC, Anhui Province Hospital
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan provincial people's hospital
state: Henan
city: Liaocheng
country: China
facility: Liaocheng people's Hospital
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Tianjin
country: China
facility: Institute of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Shanghai
country: China
facility: Jiading Central Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: