UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Title of the study (Brief title)	Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical response (at week 4)
Key secondary outcomes	1) Clinical remission (at week 4) 2) Proportion of patients with positive for CMV 3) Change of viral load of CMV-DNA

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks)
Interventions/Control_2	Additional immunosuppressive therapies without administration of ganciclovir
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	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key 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
Target sample size	120

Research contact person
Name of lead principal investigator	Hiroshi Nakase
Organization	Sapporo Medical University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	South-1, West-16, Chuo-ku, Sapporo, 060-8543, JAPAN
TEL	011-611-2111
Email	hiropynakase@gmail.com

Public contact
Name of contact person	Minoru Matsuura
Organization	Kyoto University Hospital
Division name	Division of Endoscopic Medicine
Address	54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	075-751-4319
Homepage URL
Email	minomats@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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

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	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）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 02 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026040