UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000225 |
|---|---|
| Receipt number | R000000280 |
| Scientific Title | Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis |
| Date of disclosure of the study information | 2008/09/13 |
| Last modified on | 2015/08/30 09:49:48 |
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Basic information
Public title
Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis
Acronym
GLSG,2004,PBC
Scientific Title
Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis
Scientific Title:Acronym
GLSG,2004,PBC
Region
| Japan |
Condition
Condition
Primary biliary cirrhosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of bezafibrate as add-on therapy for Primary biliary cirrhosis (PBC)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ALP, gamma-GTP
Key secondary outcomes
cytokines
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:UDCA+Bezafibrate
Bezafibrate: 400mg/day for 12 months
Dose of pretreatment UDCA is not changed after entry.
Interventions/Control_2
control:UDCA only
Dose of pretreatment UDCA is not changed after entry.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PBC (Primary Biliary Cirrhosis) with elevated ALP (more than 350IU/ml) in spite of more than 6 months administration of UDCA (ursodeoxycholic acid) and hyperlipidemia (TG>150mg/dl or T-Chol>220mg/dl)
Key exclusion criteria
liver diseases with other causes, such as chronic hepatitis B or C, or autoimmune hepatitis
Severe renal diseases
administration of steroids or glycyrrhizin
within three months before entry
administration of other fibrates
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8127
Homepage URL
satoken@showa.gunma-u.ac.jp
Sponsor or person
Institute
Gunma Liver Study Group
Institute
Department
Personal name
Funding Source
Organization
Gunma Liver Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2003 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000280
