A Phase 3 interventional study of AK1820 and Voriconazole in Deep Mycosis, sponsored by Asahi Kasei Pharma Corporation. Completed at 33 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by Asahi Kasei Pharma Corporation · Phase 3, Interventional, and Treatment
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).
134 studies on the registry are indexed under Aspergillosis; 10 are open to participants now.
This study's enrollment of 103 is above the median of 47 across 75 interventional studies indexed under Aspergillosis.
Browse Aspergillosis studies →Asahi Kasei Pharma Corporation is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Patients must have the below proven, probable or possible deep mycosis;
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.
Drug: AK1820
Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.
Drug: Voriconazole
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
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
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
Time frame: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Time frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Percentage of participants with clinical, radiological and mycological response assessed by the DRC.
Time frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.
Time frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
All-cause mortality.
Time frame: Through 28 days after the last dose of study drug (up to approximately Day 112).
Plan to share: No
Ran from Apr 2018 to primary completion in Apr 2021, 36 months.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isavuconazole
Asahi Kasei Pharma Corporation