Unique ID issued by UMIN | C000000228 |
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Receipt number | R000000287 |
Scientific Title | long-term low-dose Natural IFN-alpha for patients with chronic hepatits C |
Date of disclosure of the study information | 2005/09/13 |
Last modified on | 2015/08/30 10:13:14 |
long-term low-dose Natural IFN-alpha for patients with chronic hepatits C
GLSG,2005.Sumiferon
long-term low-dose Natural IFN-alpha for patients with chronic hepatits C
GLSG,2005.Sumiferon
Japan |
Chronic hepatitis C
Medicine in general | Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of long-term low-dose natural IFN alpha treatment for patients with chronic hepatitis C to prevent incidence of hepatocellular carcinoma by normalization of ALT
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
liver function-transaminase
virological response
Incidence of hepatocellular carcinoma
safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Numbered container method
2
Treatment
Medicine |
intervention:Sumiferon
control:SNMC
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1 patients who agreeed with this study
pretreatment is insufficient
2 positive test for HCV-RNA,
abnormal ALT
1 Allergy to IFN or cow-derived substances
2 Allergy to biological products such as vaccine
3 essential to administration of sho- saiko-to
4 liver diseases with other causes such as autoimmune hepatitis, alcoholic hepatitis
5 patients with previously-diagnosed HCC
6 Leucopenia(less than 2000) or thrombopenia (less than 50000)
7 central nerve sytem manifestation or psychosomatic disorders
8 severe complications
9 during pregnancy or lactation
10 inappropriate subjects judged by physicinas
11 patients hoping for certain therapeutic methods
20
1st name | |
Middle name | |
Last name | Ken Sato |
Gunma University Graduate School of Medicine
Department of Medicine and Molecular Science
3-39-22 Showa,Maebashi Gunma 371-8511, Japan
027-220-8127
satoken@gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Ken Sato |
Gunma University Graduate School of Medicine
Department of Medicine and Molecular Science
3-39-22 Showa, Maebashi Gunma 371-8511, Japan
027-220-8127
satoken@showa.gunma-u.ac.jp
Gunma Liver Study Group
Gunma Liver Study Group
Self funding
Japan
NO
2005 | Year | 09 | Month | 13 | Day |
Unpublished
Terminated
2003 | Year | 12 | Month | 01 | Day |
2004 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 13 | Day |
2015 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000287
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