Deep mycosis
Conditions
Interventions
investigational material(s)
Generic name etc : AK1820
INN of investigational material : Isavuconazonium sulfate
Therapeutic category code : 617 Antibiotic preparations acting mainly on mold
Dosage and
a switch from oral administration to IV infusion will not be possible.
control material(s)
Generic name etc : Voriconazole
INN of investigational material : Voriconazole
Therapeutic category code : 6
a switch from oral administration to IV infusion will not be possible.
Sponsors
ASAHI KASEI THERAPEUTICS CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria Patients fulfilling one of the below definitions; (1) invasive aspergillosis (2) chronic pulmonary aspergillosis (3) mucormycosis (4) cryptococcosis Women with negative pregnancy tests who intend to properly use contraception during the study, or women with no possibility of becoming pregnant.
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria Women who are pregnant or breastfeeding. Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product. Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval. Patients with a history of short QT syndrome. Patients with liver dysfunction at enrollment. Patients with moderate to severe kidney dysfunction at enrollment. Patients who receive prohibited concomitant drugs. Patients with any other fungal infection other than Aspergillus species, Mucorales, or Cryptococcus species. Patients who are not expected to survive study duration. Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations. Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment. Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC) at Day 42, Day 84 and End of Treatment. Percentage of participants with clinical, radiological and mycological response assessed by the DRC at Day 42, Day 84 and End of Treatment. Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator at Day 42, Day 84 and End of Treatment. All-cause mortality through 28 days after the last dose of study drug. | — |
Countries
Japan
Contacts
Public ContactContact for Clinical Trial Information
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed