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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
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
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
Research site
Nagakute, Aichi-ken, Japan
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
Time frame: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 28 days after the last dose of study drug (up to approximately Day 112).
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Research site
Nagoya, Aichi-ken, Japan
Research site
Seto, Aichi-ken, Japan
Research site
Higashiku, Fukuoka, Japan
Research site
Minamiku, Fukuoka, Japan
Research site
Nagara, Gifu, Japan
Research site
Naka-Ku, Hiroshima, Japan
Research site
Asahikawa, Hokkaido, Japan
Research site
Kawasaki, Kanagawa, Japan
Research site
Yokohama, Kanagawa, Japan
...and 23 more locations