臨床研究等提出・公開システム

Date of registration	July. 23, 2026
Last modified on	July. 23, 2026
Trial ID	jRCT2021260026

Scientific Title	Phase II study of AK1820 in Japanese pediatric patients
Public Title	Phase II study of AK1820 in Japanese pediatric patients

Contact for Scientific Queries	Name	Kishida Mitsukazu
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 01, 2026
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	[1] Pediatric patients at high risk of developing deep mycosis [2] Patients for whom written informed consent to participate in this clinical study has been obtained from a legal representative (such as a parent), and patients from whom consent or confirmation of intent to participate has been obtained, but only where the principal investigator has determined that the patient is capable of understanding the details of the study [3] Japanese patients aged 1 year or older but under 18 years of age at the time consent is obtained [4] For female patients: those with a negative pregnancy test result who are willing to use medically appropriate contraception during the study period, or those for whom pregnancy is not a possibility
	Exclusion Criteria	[1] Patients who are pregnant or breastfeeding [2] Patients with a history of allergy, hypersensitivity, or severe reactions to azole antifungal agents or any component of the investigational product [3] Patients with familial short QT syndrome. Patients receiving drugs known to shorten the QT interval, or patients with clinically significant ECG abnormalities [4] Patients whose laboratory test results, such as liver function tests, are within acceptable ranges in the most recent laboratory tests conducted prior to the start of investigational product administration [5] Patients with a history of administration of isavuconazonium sulfate [6] Patients whom the principal investigator determines are unsuitable for participation in the clinical study
	Age Minimum	1age old over
	Age Maximum	18age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Deep mycosis
Intervention(s)		Patients will receive isavuconazonium sulfate by intravenous infusion (IV) or orally. The dosage of isavuconazonium sulfate is determined based on the patient's age and weight.
Primary Outcome(s)		Safety endpoints: Treatment-emergent adverse events (TEAE), vital signs, clinical tests and ECG test
Secondary Outcome(s)		Pharmacokinetic endpoints: Plasma isavuconazole concentration and pharmacokinetic parameters

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION

Name of Certified Review Board	ACTIVATO Review Board
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Miyagi
Telephone	+81-22-346-0325
Approval Status	Not approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none