UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022588
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

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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 or person

Institute

Department of Gastroenterology and Hepatology, Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.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