臨床研究等提出・公開システム

Date of registration	June. 13, 2018
Last modified on	Dec. 17, 2020
Trial ID	jRCT2080223943

Scientific Title	An Open-label Study to Assess the Effect of JTT-751 as Iron Replacement Therapy in Patients with Iron Deficiency Anemia
Public Title	An open-label study in patients with iron deficiency anemia

Completion Date or Terminated date	Dec. 25, 2019
Actual Enrolled Number	73
Baseline Characteristics	Baseline characteristcs did not differ significantly between groups.
Participant flow	Total of 73 patients were enrolled.
Adverse events	JTT-751 showed a favorable tolerability profile.
Primary Outcome Measures	Serum ferritin levels increased after the start of treatment with JTT-751.
Secondary Outcome Measures	The time profiles of iron-related test values showed an improvement in the iron-deficient state associated with JTT-751 treatment.
Brief summary	The efficacy and safety of JTT-751 were confirmed in patients with iron deficiency anemia.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Undecided
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Shionogi & Co.,Ltd.
	Address
	Phone Number
	E-mail Address	clinicaltrials-info@shionogi.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Shionogi & Co.,Ltd.
	Address
	Phone Number
	E-mail Address	clinicaltrials-info@shionogi.co.jp

Recruitment Status	completed

Date of First Enrolment		July. 25, 2018
Target Sample Size		70
Study Type		Interventional
Study Design	Study Design	Multi-center, Uncontrolled, Open-label study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Iron deficiency anemia Hemoglobin level of >= 8.0 g/dL and < 11.0 g/dL
	Exclusion Criteria	* Anemia caused by other than iron deficiency * Serum phosphate < 2.5 mg/dL or >= 4.5 mg/dL * Patients scheduled surgical treatment for gynecological diseases with hypermenorrhea during participation
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Iron Deficiency Anemia
Intervention(s)		investigational material(s) Generic name etc : Ferric Citrate Hydrate INN of investigational material : - Therapeutic category code : 322 Mineral preparations Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Changes in serum ferritin level
Secondary Outcome		efficacy Changes in iron-related test values

Primary Sponsor	Japan Tobacco Inc.
Secondary Sponsor	-

Name of Funding Organization	Torii Pharmaceutical Co.,Ltd.
Name of Research Funding	-

Name of IRB	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address of IRB	13-2 Ichibancho, Chiyoda-ku, Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	July. 20, 2018

Secondary ID No.	JapicCTI-184000
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Dec. 17, 2020	(this page)	Changes
6	May. 13, 2020	Detail	Changes
5	May. 13, 2019	Detail	Changes
4	Jan. 29, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	June. 13, 2018	Detail	Changes
1	June. 13, 2018	Detail

List of change history