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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001627
Receipt No. 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

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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
Email 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
Email atamori@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001934

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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