A phase 3, multi-center, open label study to evaluate safety and efficacy of AK1820 for treatment of adult Japanese patients with deep mycosis.
- Conditions
- Deep mycosis
- Registration Number
- JPRN-jRCT2080223864
- Lead Sponsor
- ASAHI KASEI PHARMA CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 103
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.
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
- Primary Outcome Measures
Name Time Method safety<br>Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
- Secondary Outcome Measures
Name Time Method efficacy<br>Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC) at Day 42, Day 84 and End of Treatment.<br>Percentage of participants with clinical, radiological and mycological response assessed by the DRC at Day 42, Day 84 and End of Treatment.<br>Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator at Day 42, Day 84 and End of Treatment.<br>All-cause mortality through 28 days after the last dose of study drug.