Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
1 other identifier
interventional
103
1 country
33
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2018
Typical duration for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 21, 2018
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2021
CompletedMay 14, 2021
January 1, 2021
3 years
February 26, 2018
May 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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).
Study Arms (2)
AK1820
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients must have the below proven, probable or possible deep mycosis;
- invasive aspergillosis
- chronic pulmonary aspergillosis
- mucormycosis
- cryptococcosis
- Female patients must be non-lactating and at no risk for pregnancy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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
Related Publications (2)
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.
PMID: 36307059DERIVEDShirae 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.
PMID: 35191210DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2018
First Posted
March 21, 2018
Study Start
April 16, 2018
Primary Completion
April 21, 2021
Study Completion
April 21, 2021
Last Updated
May 14, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share