UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027442 |
|---|---|
| Receipt number | R000031442 |
| Scientific Title | Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2022/11/24 10:03:54 |
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Basic information
Public title
Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg
Acronym
Clinical trial for therapeutic HB vaccine
Scientific Title
Phase I/II clinical trial for therapeutic HB vaccine containing HBsAg and HBcAg
Scientific Title:Acronym
Clinical trial for therapeutic HB vaccine
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 ensure the safety and efficacy of therapetutic vaccine in Japanese patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: frequency and degree of adverse events
Key secondary outcomes
Efficacy: HBV-DNA reduction
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 |
Interventions/Control_1
HBV patients with inactive carrier or under nucleotide analogues treatment will receive therapeutic vaccine 10 times every two weeks intranasally.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
HBV inactive carrier
chronic hepatitis B patients treating with nucleotide analogue
Key exclusion criteria
severe complication
malignancy
taking immunosuppresive agents
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Yoshida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
454 Shitsukawa, Toon, Ehime
TEL
089-960-5308
Homepage URL
yoshidao@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ehime University Graduate School of Medicine
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
Certified Review Board,Ehime University
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.jp
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
| 2017 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/hepr.13851
Number of participants that the trial has enrolled
71
Results
The safety of HBsAg/HBcAg containing nasal administrative therapeutic vaccine. Anti-HBs induction and HBsAg reduction were confirmed after administration of the therapeutic vaccine.
Results date posted
| 2022 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Positive for either HBsAg or HBV-DNA
Participant flow
N=72 participants provided written consent. N=1 excluded due to mismatch with the criteria. N=71 completed 6 months follow-up
Adverse events
Mild AEs were temporally observed in some participants. All the AEs were cured without any medications.
Outcome measures
HBsAg reduction, anti-HBs induction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031442
