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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027070
Receipt No. R000031003
Scientific Title Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Date of disclosure of the study information 2017/04/21
Last modified on 2019/04/22

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Basic information
Public title Clinical trial of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim for recently onset type 1 diabetes
Acronym Immunomodulatory therapy using ATG/PeG-CSF 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
Scientific Title:Acronym Immunomodulatory therapy using ATG/PeG-CSF for recently onset type 1 diabetes
Region
Japan

Condition
Condition Type 1 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of immunomodulatoly therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of adverse events during 52 weeks of the treatment or observation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Anti-thymocyte globulin: 0.5 mg/kg (Day 1), 1.5
mg/kg (Day 2)
Interventions/Control_2 Pegfilgrastim: 3.6 mg x 6 times every 2 weeks (starting at Day 3)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Acute-onset type 1 diabetes
2. Within 12 months since diagnosis
3. Fasting serum C-peptide > 0.3 ng/mL
Key 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
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Chujo
Organization National Center for Global Health and Medicine
Division name Department of Diabetes, Endocrinology, and Metabolism
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3201-7181
Email dchujo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Chujo
Organization National Center for Global Health and Medicine
Division name Department of Diabetes, Endocrinology, and Metabolism
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3201-7181
Homepage URL
Email dchujo@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board of National Center for Global Health and Medicine
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 12 Month 27 Day
Date of IRB
2016 Year 12 Month 26 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 19 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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