Deep Mycosis
Conditions
Keywords
deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba
Brief summary
The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).
Interventions
DRUGAK1820
Only a switch from IV infusion (vial) to oral administration (capsule) will be permitted; a switch from oral administration to IV infusion will not be possible. 372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole. Other Names: Cresemba, BAL8557
DRUGVoriconazole
Only a switch from IV infusion (vial) to oral administration (tablet) will be permitted; a switch from oral administration to IV infusion will not be possible. Other Name : VFend
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Patients must have the below proven, probable or possible deep mycosis; 1. invasive aspergillosis 2. chronic pulmonary aspergillosis 3. mucormycosis 4. cryptococcosis * Female patients must be non-lactating and at no risk for pregnancy. 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, order 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 |
|---|---|
| Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up. | From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112). |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC). | Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment. |
| Percentage of participants with clinical, radiological and mycological response assessed by the DRC. | Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment. |
| Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator. | Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment. |
| All-cause mortality. | Through 28 days after the last dose of study drug (up to approximately Day 112). |
Countries
Japan
Outcome results
None listed