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

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 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


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

Value
https://center6.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