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

Study Overview
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Brief Summary
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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
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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

Conditions
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Invasive Fungal Disease

Intervention / Treatment
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* Drug: Isavuconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isavuconazole<br>This is a single arm study, all enrolled participants will receive the study medication. | Drug: Isavuconazole<br>* This is a single arm study, all enrolled participants will receive the study intervention.<br>* Other names: Cresemba®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Isavuconazole, Invasive Aspergillus, Invasive mold