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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000027070
Date of registration:	21/04/2017
Prospective Registration:	No
Primary sponsor:	Toyama University
Public title:	Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Scientific title:	Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes - Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Date of first enrolment:	2017/03/01
Target sample size:	20
Recruitment status:	Complete: follow-up continuing
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031003
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Daisuke Chujo
Address:	2630, Sugitani, Toyama, Japan Japan
Telephone:	076-434-2281
Email:	dchujo@med.u-toyama.ac.jp
Affiliation:	Toyama University Hospital Center for Clinical Research

Name:	Daisuke Chujo
Address:	2630, Sugitani, Toyama, Japan 930-0194 Japan
Telephone:	076-434-2281
Email:	dchujo@med.u-toyama.ac.jp
Affiliation:	Toyama University Hospital Center for Clinical Research

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Active infection 2. Pregnancy/breast-feeding 3. Past history of malignant tumor 4. Interstitial pneumonia 5. Severe liver or/and kidney dysfunction 6. Past history of ATG administration 7. Under systemic steroid therapy

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Type 1 diabetes

Intervention(s)

Anti-thymocyte globulin: 0.5 mg/kg (Day 1), 1.5 mg/kg (Day 2)
Pegfilgrastim: 3.6 mg x 6 times every 2 weeks (starting at Day 3)

Primary Outcome(s)

Frequency of adverse events during 52 weeks of the treatment or observation

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Japan IDDM Network

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 26/12/2016
Contact:

rinrijm@hosp.ncgm.go.jp

Certified Review Board of National Center for Global Health and Medicine

03-3202-7181

rinrijm@hosp.ncgm.go.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2022
URL:

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