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Japanese

June. 13, 2018

Dec. 17, 2020

jRCT2080223943

An Open-label Study to Assess the Effect of JTT-751 as Iron Replacement Therapy in Patients with Iron Deficiency Anemia

An open-label study in patients with iron deficiency anemia

Dec. 25, 2019

73

Baseline characteristcs did not differ significantly between groups.

Total of 73 patients were enrolled.

JTT-751 showed a favorable tolerability profile.

Serum ferritin levels increased after the start of treatment with JTT-751.

The time profiles of iron-related test values showed an improvement in the iron-deficient state associated with JTT-751 treatment.

The efficacy and safety of JTT-751 were confirmed in patients with iron deficiency anemia.

Undecided

version:
date:

Japan Tobacco Inc.

clinicaltrials-info-j@jt.com

Japan Tobacco Inc.

clinicaltrials-info-j@jt.com

completed

July. 25, 2018

70

Interventional

Multi-center, Uncontrolled, Open-label study

treatment purpose

3

Iron deficiency anemia
Hemoglobin level of >= 8.0 g/dL and < 11.0 g/dL

* 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

20age old over
No limit

Both

Iron Deficiency Anemia

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 : -

efficacy
Changes in serum ferritin level

efficacy
Changes in iron-related test values

Japan Tobacco Inc.
-
Torii Pharmaceutical Co.,Ltd.
-
Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
13-2 Ichibancho, Chiyoda-ku, Tokyo

approved

July. 20, 2018

JapicCTI-184000
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