NCT03471988

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Asahi Kasei Therapeutics Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Deep Mycosis

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2018-04-16
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2018-03-21
• Last updated: 2021-05-14

Locations

33 sites across 1 country: Japan