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
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
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
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
