臨床研究等提出・公開システム

Date of registration	Aug. 06, 2024
Last modified on	Feb. 27, 2026
Trial ID	jRCT2031240252

Scientific Title	Ferinject Intravenous Injection 500mg General Use Result Survey
Public Title	Ferinject Intravenous Injection 500mg General Use Result Survey

Completion date	Oct. 02, 2025
Result actual enrolment	1073
Baseline Characteristics	Patients with iron deficiency anemia.
Participant flow	Survey End
Adverse events	The incidence of side effects was 5.13% (54/1,053 cases).
Outcome measures	The incidence of side effects was 5.13% (54/1,053 cases), and no new problems were observed in the side effects that occurred. Furthermore, no serious side effects were observed. Regarding factors that affect the occurrence of side effects, statistically significant differences were observed between "pregnancy status," "presence or absence of allergy history," and "average single dose," but no tendency for the occurrence of particularly problematic side effects was observed in each group.
Brief summary	The results of this general use surveillance survey indicated that there were no particular problems with the safety or efficacy of this drug.

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2031240252

Contact for Scientific Queries	Name	Contact for Pharmacovigilance
	Affiliation	ZERIA Pharmaceutical Co., Ltd.
	Address	10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo
	Telephone	+81-3-3663-2362
	E-mail	iyakujo@zeria.co.jp
Contact for Public Queries	Name	Contact for Pharmacovigilance
	Affiliation	ZERIA Pharmaceutical Co., Ltd.
	Address	10-11, Nihonbashi Kobuna-cho, Chuo-ku, Tokyo
	Telephone	+81-3-3663-2362
	E-mail	iyakujo@zeria.co.jp

Recruitment status	Complete


Anticipated date of first enrollment		Sept. 01, 2021
Actual date of first enrollment		Sept. 07, 2021
Target sample size		1000
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with iron deficiency anaemia who were treated Ferinject.
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Iron deficiency anaemia
Primary Outcome(s)		Adverse event

Primary Sponsor	Zeria pharmaceutical Co.,Ltd

Name of Certified Review Board	N/A
Address	N/A, Tokyo

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 27, 2026	(this page)	Changes
1	Aug. 06, 2024	Detail

List of change history