Unique ID issued by UMIN | UMIN000027070 |
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Receipt number | 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 | 2021/04/22 09:02:38 |
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
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
Japan |
Type 1 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate the safety and efficacy of immunomodulatoly therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes.
Safety,Efficacy
Frequency of adverse events during 52 weeks of the treatment or observation
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
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)
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Acute-onset type 1 diabetes
2. Within 12 months since diagnosis
3. Fasting serum C-peptide > 0.3 ng/mL
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
20
1st name | Daisuke |
Middle name | |
Last name | Chujo |
Toyama University Hospital
Center for Clinical Research
930-0194
2630, Sugitani, Toyama, Japan
076-434-2281
dchujo@med.u-toyama.ac.jp
1st name | Daisuke |
Middle name | |
Last name | Chujo |
Toyama University Hospital
Center for Clinical Research
930-0194
2630, Sugitani, Toyama, Japan
076-434-2281
dchujo@med.u-toyama.ac.jp
Toyama University
Japan IDDM Network
Non profit foundation
Certified Review Board of National Center for Global Health and Medicine
1-21-1, Toyama, Shinjuku, Tokyo, Japan
03-3202-7181
rinrijm@hosp.ncgm.go.jp
NO
2017 | Year | 04 | Month | 21 | Day |
Unpublished
12
No longer recruiting
2016 | Year | 12 | Month | 27 | Day |
2016 | Year | 12 | Month | 26 | Day |
2017 | Year | 03 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 31 | Day |
2017 | Year | 04 | Month | 19 | Day |
2021 | Year | 04 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031003
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