UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005978 |
|---|---|
| Receipt number | R000007072 |
| Scientific Title | Hepatitis B vaccination for patients with chronic hepatitis B |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2013/11/05 21:52:07 |
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Basic information
Public title
Hepatitis B vaccination for patients with chronic hepatitis B
Acronym
HBV vaccination for chronic hepatitis B
Scientific Title
Hepatitis B vaccination for patients with chronic hepatitis B
Scientific Title:Acronym
HBV vaccination for chronic hepatitis B
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To induce the production of aniti-HBs antibody by hepatitis B vaccination in patients with chronic hepatitis B treated with nucleoside analogues
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of patients who are positive for anti-HBs antibody at 24 months after the initiation of hepatitis B vaccination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Hepatitis B vaccination
Interventions/Control_2
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) Chronic hepatitis B
2) Treatment with nucleoside analogues more than 3 months
3) Serum HBV-DNA<3 logIU/mL by Taqman PCR method
4) 20 years old or more
5) Possible to treat in Kyoto University Hospital
6) With written informed consent
Key exclusion criteria
1) fever
2) severe acute disease
3) past history of anaphylactic reaction to hepatitis B vaccine
4) pregnancy
5) inappropriate cases judged by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihide Ueda |
Organization
Kyoto University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2011 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 14 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007072
