Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
NCT ID: NCT03471988
Last Updated: 2021-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2018-04-16
2021-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AK1820
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.
AK1820
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
Voriconazole
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.
Voriconazole
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
Interventions
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AK1820
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
Voriconazole
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
Eligibility Criteria
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Inclusion Criteria
1. invasive aspergillosis
2. chronic pulmonary aspergillosis
3. mucormycosis
4. cryptococcosis
* Female patients must be non-lactating and at no risk for pregnancy.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Asahi Kasei Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Research site
Nagakute, Aichi-ken, Japan
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
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
Countries
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References
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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.
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.
Other Identifiers
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AK1820-301
Identifier Type: -
Identifier Source: org_study_id
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