UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Acronym	KIBDG-Protocol 1
Scientific Title	The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Scientific Title:Acronym	KIBDG-Protocol 1
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Medicine in general Gastroenterology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of treatment with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Induction remission rate
Key secondary outcomes	Response rate Negativity of cytomegalovirus infection

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	A Group: Ganciclovir monotherapy
Interventions/Control_2	B Group: Ganciclovir and GMAA combination therapy
Interventions/Control_3	C Group: GMAA monotherapy
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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis refractory to corticosteroids or immunomodulators
Key exclusion criteria	1: white blood cell counts<2000/mm3, Hb<8g/dl 2: severe cardiovascular disease, hepatic failure, Renal failure, Respiratory faiure, Nervous disease 3: Pregnancy 4: Inadequate patients for study
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Tsutomu Middle name Last name Chiba
Organization	Graduate School of Medicine, Kyoto University
Division name	Gastroenterology and Hepatology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL	075-75-4319
Email	chiba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Nakase
Organization	Graduate School of Medicine, Kyoto University
Division name	Gastroenterology and Hepatology
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL	075-75-4319
Homepage URL
Email	hiropy_n@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	JIMRO
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board of Kyoto university
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	京都大学病院（京都府）、京都桂病院（京都府）、京都第一赤十字病院（京都府）、京都第二赤十字病院（京都府）、三菱京都病院（京都府）、滋賀医科大学（滋賀県）、大津赤十字病院（滋賀県）、兵庫医科大学（兵庫県）、神戸市立中央市民病院（兵庫県）、西神戸医療センター（兵庫県）、神戸市立西市民病院（兵庫県）、関西医科大学附属枚方病院（大阪府）、大阪市立大学附属病院（大阪府）、近畿大学附属病院（大阪府）、北野病院（大阪府）、大阪赤十字病院（大阪府）、高槻病院（大阪府）、西下胃腸病院（大阪府）、ＪＲ大阪鉄道病院（大阪府）、青山内科胃腸科クリニック（兵庫県）、天理よろづ相談所病院（奈良県）、生駒消化器科クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 31 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	Open public recruiting
Date of protocol fixation	2006 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date	2007 Year 03 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	2014 Year 05 Month 11 Day
Last modified on	2019 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016237

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name
2019/05/23	data2015.2.26 - コピー.xlsx

Research case data
Registered date	File name

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