臨床研究等提出・公開システム

Date of registration	Feb. 03, 2025
Last modified on	Feb. 03, 2025
Trial ID	jRCT2031240659

Scientific Title	MEGLUDASE for Intravenous Use 1000 General Drug Use-Results Survey (All-case surve ) (MEGLUDASE for Intravenous Use 1000 General Drug Use-Results Survey (All-case surve ))
Public Title	MEGLUDASE for Intravenous Use 1000 General Drug Use-Results Survey (All-case surve ) (MEGLUDASE for Intravenous Use 1000 General Drug Use-Results Survey (All-case surve ))

Contact for Scientific Queries	Name	Mitsuharu Osawa
	Affiliation	OHARA Pharmaceutical Co., Ltd.
	Address	36F St. Luke's Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan
	Telephone	+81-3-6740-7701
	E-mail	mitsuharu-osawa@ohara-ch.co.jp
Contact for Public Queries	Name	Mitsuharu Osawa
	Affiliation	OARA Pharmaceutical Co., Ltd.
	Address	36F St. Luke's Tower, 8-1, Akashi-cho, Chuo-ku, Tokyo 104-6591, Japan
	Telephone	+81-3-6740-7701
	E-mail	mitsuharu-osawa@ohara-ch.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 01, 2024
Actual date of first enrollment		Jan. 03, 2025
Target sample size		50
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who received meglutase for detoxification during delayed methotrexate excretion due to methotrexate/leucovorin rescue therapy
	Exclusion Criteria	Patients with a history of severe hypersensitivity to the components of meglutase
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Toxic effects caused by delayed methotrexate excretion due to methotrexate-leucovorin rescue therapy
Intervention(s)		none
Health Condition(s) Code		C23
Primary Outcome(s)		Safety(incidence of side effects,etc.)
Secondary Outcome(s)		Changes in blood methotrexate concentration

Primary Sponsor	OHARA Pharmaceutical Co., Ltd.

Name of Certified Review Board	none
Address	none, Tokyo

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none