UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002568 |
|---|---|
| Receipt number | R000002674 |
| Scientific Title | The vaccine therapy for chronic hepatitis B |
| Date of disclosure of the study information | 2009/09/30 |
| Last modified on | 2018/01/17 08:51:24 |
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Basic information
Public title
The vaccine therapy for chronic hepatitis B
Acronym
The vaccine therapy for chronic hepatitis B
Scientific Title
The vaccine therapy for chronic hepatitis B
Scientific Title:Acronym
The vaccine therapy for chronic hepatitis B
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To induce the HBs seroconversion and the suppression of hepatitis by the combination therapy with nucleotide analogues, HBIG and HB vaccine in chronic hepatitis B patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Drug withdrawal rate
Key secondary outcomes
1)Virological effects
2)Virological CR rate(Sustainment of negative status of HBV markers, such as HBs antigen, HBe antigen, HBV DNA, and positive status of anti-HBs antibody)
3)The conditions of the treatment
4)The relation between HBV drug resitants and virological responses
5)Serological responses
6)Quality of patients' life
7)Side effects of this study
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Nucleotide analogue daily, HBIG 1,000IU/month, HB vaccine 10-20ug/month
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Chronic hepatitis B patients treated with nucleotide analogues.
2. The titers of HBs antigen was reduced less than 500 C.O.I. with the nucleotide analogue therapy.
3. Without liver cirrhosis and hepatocellular carcinoma.
Key exclusion criteria
1. Hypersensitivity to nucleotide analogues, HBIG, HB vaccine or any other vaccines
2. Pregnant or nursing
3. Heart disease with uncontrolled status
4. Severe acute disease
5. Fever more than 37.5C
6. Renal dysfunction
7. IgA deficiency
8. Anemia caused by hemolysis or the loss of blood
9. Immunocompromised of immunosuppressive status
10. Chronic liver dysfunction except for HBV infection
11. The others who were disqualified to entry this trial by attending physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima university
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, 734-8551, Japan
TEL
082-257-5190
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Tsuge |
Organization
Hiroshima university
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-shi, 734-8551, Japan
TEL
082-257-5555(6814)
Homepage URL
masataka-tsuge@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabolism, Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Metabolism, Hiroshima university
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
| 2009 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00535-016-1189-x
Number of participants that the trial has enrolled
Results
Eight chronic hepatitis B patients, who had received long-term nucleotide analogue treatment, were treated with monthly HBIG injections as an additional treatment. After 1 year of treatment, an HBsAg level reduction of more than 1 log IU/mL was observed in four patients, and three patients became anti-HBs positive. No adverse events occurred during HBIG therapy.
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
| 2009 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002674
