Phase 4
N=70
Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
Invasive Fungal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05630976 ↗Enrolled (actual)
70
Serious AEs
31.4%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 55; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isavuconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
55; 9 | — |
| SECONDARY All-cause Mortality Rate Through Day 42 |
14.3 | — |
| SECONDARY All-cause Mortality Rate Through Day 84 |
28.6 | — |
| SECONDARY Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population |
62.7; 56.9; 60.8 | — |
| SECONDARY Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population |
61.9; 57.1; 61.9 | — |
| SECONDARY Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population |
73.5; 66; 69.4 | — |
| SECONDARY Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population |
72.5; 65.9; 72.5 | — |
| SECONDARY Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population |
72; 64.7; 68 | — |
| SECONDARY Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population |
70.7; 64.3; 70.7 | — |
| SECONDARY Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population |
66; 60; 64 | — |
| SECONDARY Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population |
66.7; 61.9; 66.7 | — |
| SECONDARY Number of Participants With Treatment Related TEAEs |
23; 9 | — |
| SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) |
19; 3 | — |
| SECONDARY Number of Participants With TEAEs Leading to Study Intervention Discontinuation |
4; 0 | — |
| SECONDARY Number of Participants With TEAEs Leading to Death |
9; 2 | — |
| SECONDARY Number of Participants With Death |
11; 2 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
60; 8 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria |
2; 0; 5; 0; 2; 0 | — |
| SECONDARY Number of Participants With Abnormal Eye Examination |
3; 1 | — |
| SECONDARY Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit |
3920; 5076; 4715; 5394; 5824; 5357 | — |
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
Data sourced from ClinicalTrials.gov (NCT05630976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.