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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK1820 | Experimental | Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days. |
|
| Voriconazole | Active Comparator | Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK1820 | Drug | 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 |
| Measure | Description | 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). |
| Measure | Description | 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. |
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Main Inclusion Criteria:
Patients must have the below proven, probable or possible deep mycosis;
Female patients must be non-lactating and at no risk for pregnancy.
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Nagakute | Aichi-ken | Japan | |||
| Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36307059 | Derived | Kohno S, Izumikawa K, Takazono T, Miyazaki T, Yoshida M, Kamei K, Ogawa K, Taniguchi S, Akashi K, Tateda K, Mukae H, Miyazaki Y, Okada F, Kanda Y, Kakeya H, Suzuki J, Kimura SI, Kishida M, Matsuda M, Niki Y. Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan. J Infect Chemother. 2023 Feb;29(2):163-170. doi: 10.1016/j.jiac.2022.10.010. Epub 2022 Oct 25. | |
| 35191210 |
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|
| Voriconazole | Drug | 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 |
|
| 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). |
| 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 |
| Research site | Chuo-Ku | Kumamoto | Japan |
| Research site | Tsu | Mie-ken | Japan |
| Research site | Isahaya | Nagasaki | Japan |
| Research site | Ōmura | Nagasaki | Japan |
| Research site | Sasebo | Nagasaki | Japan |
| Research site | Tenri | Nara | Japan |
| Research site | Yufu | Oita Prefecture | Japan |
| Research site | Kurashiki | Okayama-ken | Japan |
| Research site | Nakagami | Okinawa | Japan |
| Research site | Abeno-Ku | Osaka | Japan |
| Research site | Sakai | Osaka | Japan |
| Research site | Ōmiya | Saitama | Japan |
| Research site | Hamamatsu | Shizuoka | Japan |
| Research site | Shimotsuke | Tochigi | Japan |
| Research site | Kiyose | Tokyo | Japan |
| Research site | Minato-Ku | Tokyo | Japan |
| Research site | Mitaka | Tokyo | Japan |
| Research site | Ōta-ku | Tokyo | Japan |
| Research site | Shinagawa-Ku | Tokyo | Japan |
| Research site | Shinjuku-Ku | Tokyo | Japan |
| Research site | Chiba | Japan |
| Research site | Ibaraki | Japan |
| Research site | Nagasaki | Japan |
| Derived |
| Shirae S, Ose A, Kumagai Y. Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects. Clin Pharmacol Drug Dev. 2022 Jun;11(6):744-753. doi: 10.1002/cpdd.1079. Epub 2022 Feb 21. |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D009091 | Mucormycosis |
| D003453 | Cryptococcosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D020096 | Zygomycosis |
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| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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