A phase 3, multi-center, open label study to evaluate safety and efficacy of AK1820 for treatment of adult Japanese patients with deep mycosis.

Phase 3

Completed

• Conditions: Deep mycosis

• Registration Number: JPRN-jRCT2080223864
• Lead Sponsor: ASAHI KASEI PHARMA CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Study Completion: 2021-04-21
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Main Inclusion Criteria
Patients fulfilling one of the below definitions;
(1) invasive aspergillosis
(2) chronic pulmonary aspergillosis
(3) mucormycosis
(4) cryptococcosis
Women with negative pregnancy tests who intend to properly use contraception during the study, or women with no possibility of becoming pregnant.

Exclusion Criteria

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, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified