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

C3791001

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.

2023-02-07

2025-05-23

2025-06-27

Recruiting

Early phase I

56

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

2024-04-03