UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042288 |
|---|---|
| Receipt number | R000044149 |
| Scientific Title | The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study) |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2022/05/06 07:38:31 |
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Basic information
Public title
The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study)
Acronym
Hepatitis B Virus Vaccination to Prevent HBV Reactivation
Scientific Title
The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study)
Scientific Title:Acronym
Hepatitis B Virus Vaccination to Prevent HBV Reactivation
Region
| Japan |
Condition
Condition
Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of HBV vaccination as a prophylactic procedure for HBV reactivation in patients with previously resolved HBV infection receiving immunosuppressive therapies, serum levels of anti-HBs were evaluated in relation to serum HBV-DNA levels during the therapies after the vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentages of patients showing anti-HBs titer rises above the baseline and 10 mIU / ml or more at 4-8 weeks after vaccination among the patients received the vaccination during immunosuppressive therapy.
Key secondary outcomes
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
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
HBV vaccines at a volume of 0.5 mL are administrated by intramuscular injection for 3 times at baseline and 4 and 20 weeks later. If anti-HBs titer is less than 10 mIU /mL after vaccinations, HBV vaccines are administrated for 3 times additionally in the same way.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients tested positive for serum anti-HBs and/or anti-HBc despite of a negative serum HBs-antigen status.
Patients receiving immunosuppressive therapy.
Key exclusion criteria
Patients after HB vaccination.
Patients who have had allergic symptoms due to vaccination.
Patients with serious infections.
Pregnant and lactating women.
Patients judged by the attending physician to be ineligible.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-0495
Address
Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-0495
Address
Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL
049-276-1198
Homepage URL
smochida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Saitama Medical University
Address
Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
Tel
049-276-1354
hirb@saitama-med.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
| 2020 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
Results
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044149
