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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022588
Receipt No. 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

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Basic information
Public title Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Acronym Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Scientific Title Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Nakase
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Minoru Matsuura
Organization Kyoto University Hospital
Division name Division of Endoscopic Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 05 Month 07 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000026040

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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