UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013925
Receipt number R000016237
Scientific Title The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Date of disclosure of the study information 2014/05/31
Last modified on 2019/05/23 17:16:50

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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 or person

Institute

Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology

Institute

Department

Personal name



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

Value
https://center6.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