UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001471 |
|---|---|
| Receipt number | R000001679 |
| Scientific Title | Comparison of ursodeoxycholic acid 900 mg/day and 1200 mg/day for chronic hepatitis C patients |
| Date of disclosure of the study information | 2008/12/01 |
| Last modified on | 2010/01/25 14:21:32 |
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Basic information
Public title
Comparison of ursodeoxycholic acid 900 mg/day and 1200 mg/day for chronic hepatitis C patients
Acronym
Comparison of UDCA 900 mg/day and 1200 mg/day for chronic hepatitis C
Scientific Title
Comparison of ursodeoxycholic acid 900 mg/day and 1200 mg/day for chronic hepatitis C patients
Scientific Title:Acronym
Comparison of UDCA 900 mg/day and 1200 mg/day for chronic hepatitis C
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see whether decrease in serum ALT levels differs between 900 mg/day UDCA and 1200 mg/day UDCA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
decrease in serum ALT levels
Key secondary outcomes
adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
UDCA 900 mg/day
Interventions/Control_2
UDCA 1200 mg/day
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
positive for HCV-RNA
serum ALT >= 61 IU/L
Key exclusion criteria
decompensated cirrhosis
under anti-viral therapy
complete biliary obstruction
pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko YOSHIDA |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko YOSHIDA |
Organization
The University of Tokyo
Division name
Gastroenterology
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo
TEL
03-3815-5411
Homepage URL
yoshida-2im@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, the University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, the University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Oncology, Chiba University
Department of Gastroenterology and Hepatology, Nihon University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
P2008024-11X
Org. issuing International ID_1
The University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 31 | Day |
Last modified on
| 2010 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001679
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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