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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000022588 |
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Date of registration:
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01/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
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Scientific title:
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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. |
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Date of first enrolment:
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2016/09/01 |
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Target sample size:
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120 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026040 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Minoru Matsuura |
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Address:
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54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
Japan |
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Telephone:
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075-751-4319 |
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Email:
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minomats@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Hospital Division of Endoscopic Medicine |
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Name:
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Hiroshi Nakase |
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Address:
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South-1, West-16, Chuo-ku, Sapporo, 060-8543, JAPAN
Japan |
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Telephone:
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011-611-2111 |
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Email:
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hiropynakase@gmail.com |
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Affiliation:
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Sapporo Medical University School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
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Intervention(s)
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Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks)
Additional immunosuppressive therapies without administration of ganciclovir
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Primary Outcome(s)
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Clinical response (at week 4)
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Secondary Outcome(s)
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1) Clinical remission (at week 4) 2) Proportion of patients with positive for CMV 3) Change of viral load of CMV-DNA
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Source(s) of Monetary Support
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Ministry of Health, Labour and Welfare
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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