Clinical trial NCT03471988: Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
Official title: A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Mycosis
Keywords: deep mycosis
aspergillosis
mucormycosis
cryptococcosis
isavuconazonium sulfate
isavuconazole
AK1820
Cresemba
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
timeFrame: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
Secondary outcomes:
measure: Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
timeFrame: 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.
measure: Percentage of participants with clinical, radiological and mycological response assessed by the DRC.
timeFrame: 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.
measure: Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.
timeFrame: 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.
measure: All-cause mortality.
timeFrame: Through 28 days after the last dose of study drug (up to approximately Day 112).
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Research site
state: Aichi
city: Nagoya
country: Japan
facility: Research site
state: Aichi
city: Seto
country: Japan
facility: Research site
state: Aichi
city: Higashi-Ku
country: Japan
facility: Research site
state: Fukuoka
city: Minami-Ku
country: Japan
facility: Research site
state: Fukuoka
city: Nagara
country: Japan
facility: Research site
state: Gifu
city: Naka-Ku
country: Japan
facility: Research site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Research site
state: Hokkaido
city: Kawasaki
country: Japan
facility: Research site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research site
state: Kanagawa
city: Chuo-Ku
country: Japan
facility: Research site
state: Kumamoto
city: Tsu
country: Japan
facility: Research site
state: Mie
city: Isahaya
country: Japan
facility: Research site
state: Nagasaki
city: Sasebo
country: Japan
facility: Research site
state: Nagasaki
city: Ōmura
country: Japan
facility: Research site
state: Nagasaki
city: Tenri
country: Japan
facility: Research site
state: Nara
city: Yufu
country: Japan
facility: Research site
state: Oita
city: Kurashiki
country: Japan
facility: Research site
state: Okayama
city: Nakagami
country: Japan
facility: Research site
state: Okinawa
city: Abeno-Ku
country: Japan
facility: Research site
state: Osaka
city: Sakai
country: Japan
facility: Research site
state: Osaka
city: Ōmiya
country: Japan
facility: Research site
state: Saitama
city: Hamamatsu
country: Japan
facility: Research site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Research site
state: Tochigi
city: Kiyose
country: Japan
facility: Research site
state: Tokyo
city: Minato-Ku
country: Japan
facility: Research site
state: Tokyo
city: Mitaka
country: Japan
facility: Research site
state: Tokyo
city: Ota-Ku
country: Japan
facility: Research site
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Research site
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Research site
state: Tokyo
city: Chiba
country: Japan
facility: Research site
city: Ibaraki
country: Japan
facility: Research site
city: Nagasaki
country: Japan
facility: Research site
Study officials:
References:
citation: 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.
citation: 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.