Unique ID issued by UMIN | UMIN000022588 |
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Receipt number | R000026040 |
Scientific Title | Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection. |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2018/09/18 14:04:02 |
Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Japan |
Ulcerative colitis
Hepato-biliary-pancreatic medicine |
Others
NO
To evaluate the indication and efficacy of anti-viral therapy based on viral load of CMV determined by PCR assay using colonic tissues in active UC patients with CMV infection.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Clinical response (at week 4)
1) Clinical remission (at week 4)
2) Proportion of patients with positive for CMV
3) Change of viral load of CMV-DNA
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks)
Additional immunosuppressive therapies without administration of ganciclovir
20 | years-old | <= |
Not applicable |
Male and Female
1) Moderately to severely active ulcerative colitis (total Mayo score of 6 points or more)
2) Patients with Mayo endoscopic subscore of 2 points or more
3) Patients who provided written informed consent
1) Patients with proctitis
2) Patients with fulminant ulcerative colitis
3) Patients with serious infectious disease
4) Patients with severe bone marrow suppression
5) Patients with severe renal dysfunction
6) Patients with severe liver dysfunction
7) Patients with malignancy
8) Patients with total colectomy and subtotal colectomy
9) Patients who are pregnant or have the possibility of pregnancy
10) Patients whom investigators and subinvestigators considered to be inappropriate to participate in this study
120
1st name | |
Middle name | |
Last name | Hiroshi Nakase |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
South-1, West-16, Chuo-ku, Sapporo, 060-8543, JAPAN
011-611-2111
hiropynakase@gmail.com
1st name | |
Middle name | |
Last name | Minoru Matsuura |
Kyoto University Hospital
Division of Endoscopic Medicine
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
075-751-4319
minomats@kuhp.kyoto-u.ac.jp
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Ministry of Health, Labour and Welfare
Japanese Governmental office
JAPAN
NO
京都大学医学部附属病院(京都府)
札幌医科大学附属病院(北海道)
札幌厚生病院(北海道)
慶応大学義塾大学病院(東京都)
東京医科歯科大学病院(東京都)
東邦大学佐倉医療センター佐倉病院(千葉県)
関西医科大学病院(大阪府)
福岡大学筑紫病院(福岡県)
2016 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 07 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 06 | Month | 02 | Day |
2018 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026040
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