UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000644 |
|---|---|
| Receipt number | R000000777 |
| Scientific Title | A open-label study of entecavir for chronic hepatitis B to determine the optimum duration of administration |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2015/08/30 10:25:13 |
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Basic information
Public title
A open-label study of entecavir for chronic hepatitis B to determine the optimum duration of administration
Acronym
GLSG,2006,CHB
Scientific Title
A open-label study of entecavir for chronic hepatitis B to determine the optimum duration of administration
Scientific Title:Acronym
GLSG,2006,CHB
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the optimum duration of Entecavir administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The recurrence rate after completing Entecavir administration,
the rate of loss of serum HBV-DNA,
the rate of improvement of transaminase,
the rate of HBeAg seroconversion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group of Entecavir administration up to one year after the loss of serum HBV-DNA
Interventions/Control_2
The group of Entecavir administration up to two years after the loss of serum HBV-DNA
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
1.The cases that are not given a nucleic acid analog for chronic hepatitis B.
2.The cases that were given lamivudine have no YMDD mutation and show the serum HBV-DNA-positive.
Key exclusion criteria
1. During pregnancy and the possibility of pregnancy
2. Participating in the other clinical trials
Target sample size
70
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
3-39-15 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
3-39-15 Showa, Maebashi, Gunma, 371-8511, Japan
TEL
027-220-8127
Homepage URL
satoken@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
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
| 2014 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | 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
| 2007 | Year | 03 | Month | 17 | 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=R000000777
