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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002568
Receipt No. 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

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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
Email 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
Email masataka-tsuge@umin.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabolism, Hiroshima university
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002674

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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