UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The vaccine therapy for chronic hepatitis B
Title of the study (Brief title)	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	Kazuaki Chayama
Organization	Hiroshima university
Division name	Department of Gastroenterology and Metabolism
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	Masataka Tsuge
Organization	Hiroshima university
Division name	Department of Gastroenterology and Metabolism
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 07 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007%2Fs00535-016-1189-x
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.
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