Status:
COMPLETED
Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
Lead Sponsor:
Asahi Kasei Pharma Corporation
Conditions:
Deep Mycosis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2021
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03471988
Start Date
April 16 2018
End Date
April 21 2021
Last Update
May 14 2021
Active Locations (33)
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1
Research site
Nagakute, Aichi-ken, Japan
2
Research site
Nagoya, Aichi-ken, Japan
3
Research site
Seto, Aichi-ken, Japan
4
Research site
Higashiku, Fukuoka, Japan