JPRN-jRCT2080223864
Completed
Phase 3
A phase 3, multi-center, open label study to evaluate safety and efficacy of AK1820 for treatment of adult Japanese patients with deep mycosis.
ASAHI KASEI PHARMA CORPORATIO0 sites103 target enrollmentApril 9, 2018
ConditionsDeep mycosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Deep mycosis
- Sponsor
- ASAHI KASEI PHARMA CORPORATIO
- Enrollment
- 103
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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