UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001627 |
|---|---|
| Receipt number | R000001934 |
| Scientific Title | Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial |
| Date of disclosure of the study information | 2013/03/31 |
| Last modified on | 2014/11/06 09:18:55 |
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Basic information
Public title
Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial
Acronym
Entecavir plus HB vaccine combination trial
Scientific Title
Efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration: a randomized controlled trial
Scientific Title:Acronym
Entecavir plus HB vaccine combination trial
Region
| Japan |
Condition
Condition
HBeAg-positive chronic hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of addition of HB vaccine in patients with chronic hepatitis B who are still HBeAg-positive after one year of entecavir administration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
negative HBeAg, undetectable HBV DNA, and normal ALT at month 12 of entecavir plus HB vaccine combination therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 | Vaccine |
Interventions/Control_1
Continue oral entecavir administration at a daily dose of 0.5 mg for 12 months
Interventions/Control_2
Add HB vaccine (to entecavir) by intramuscular injection at a monthly dose of 10 microg for 12 months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.persistent or fluctuating elevations of serum ALT for at least 6 months before the start of entecavir
2.positive HBeAg before the start of entecavir
3.detectable HBV DNA before the start of entecavir
4.still HBeAg-positive after one year of entecavir administration
Key exclusion criteria
1.use of lamivudine or any other nucleos(t)ide analogues for hepatitis B
2.use of immunosuppressive or immunomodulatory drugs
3.presence of HCV infection and other likely causes of chronic liver disease
4.clinical signs of decompensated cirrhosis or liver failure
5.severe complication (poor renal, cardiac, or respiratory function)
6.women who are possibly pregnant, expectant mothers, and lactating mothers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3435
Homepage URL
atamori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 03 | 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
The present study showed that HB vaccine therapy did not have anti-HBV effect for patients with entecavir poor response.
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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 07 | Day |
Last modified on
| 2014 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001934
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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