Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

Deep Mycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471988
• Other study ID #: AK1820-301
• Status: Completed
• Phase: Phase 3
• Start date: April 16, 2018
• Est. completion date: April 21, 2021

Study information

• Verified date: January 2021
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Mycosis
• Mycoses

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Japan	Research site	Abeno-Ku	Osaka
Japan	Research site	Asahikawa	Hokkaido
Japan	Research site	Chiba
Japan	Research site	Chuo-Ku	Kumamoto
Japan	Research site	Hamamatsu	Shizuoka
Japan	Research site	Higashi-Ku	Fukuoka
Japan	Research site	Ibaraki
Japan	Research site	Isahaya	Nagasaki
Japan	Research site	Kawasaki	Kanagawa
Japan	Research site	Kiyose	Tokyo
Japan	Research site	Kurashiki	Okayama
Japan	Research site	Minami-Ku	Fukuoka
Japan	Research site	Minato-Ku	Tokyo
Japan	Research site	Mitaka	Tokyo
Japan	Research site	Nagakute	Aichi
Japan	Research site	Nagara	Gifu
Japan	Research site	Nagasaki
Japan	Research site	Nagoya	Aichi
Japan	Research site	Naka-Ku	Hiroshima
Japan	Research site	Nakagami	Okinawa
Japan	Research site	Omiya	Saitama
Japan	Research site	Omura	Nagasaki
Japan	Research site	Ota-Ku	Tokyo
Japan	Research site	Sakai	Osaka
Japan	Research site	Sasebo	Nagasaki
Japan	Research site	Seto	Aichi
Japan	Research site	Shimotsuke	Tochigi
Japan	Research site	Shinagawa-Ku	Tokyo
Japan	Research site	Shinjuku-Ku	Tokyo
Japan	Research site	Tenri	Nara
Japan	Research site	Tsu	Mie
Japan	Research site	Yokohama	Kanagawa
Japan	Research site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	All-cause mortality.		Through 28 days after the last dose of study drug (up to approximately Day 112).