UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038790 |
|---|---|
| Receipt number | R000044224 |
| Scientific Title | Usefulness of serum HBV RNA as possible marker for HBV persistent infection and reactivation |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2020/12/04 13:41:55 |
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Basic information
Public title
Usefulness of serum HBV RNA as possible marker for HBV persistent infection and reactivation
Acronym
Clinical significance of serum HBV RNA
Scientific Title
Usefulness of serum HBV RNA as possible marker for HBV persistent infection and reactivation
Scientific Title:Acronym
Clinical significance of serum HBV RNA
Region
| Japan |
Condition
Condition
Chronic hepatitis B, Acute hepatitis B, HBV cirrhosis, HBV carrier, past history of HBV infection
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing with other existing HBV viral markers, we aim to elucidate the clinical usefulness of serum HBV RNA in patients infected by HBV.
Basic objectives2
Others
Basic objectives -Others
Usefulness of a new biomarker
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation of serum HBV RNA with
1. Serum HBV DNA
2. Serum HBsAg
3. Serum HBcrAg
at inclusion, before treatment, and 1-12 months after inclusion/ treatment
Key secondary outcomes
1. Serum AST, ALT
2. Liver residual function including serum bilirubin, albumin, PT activity
3. Liver fibrosis serological markers
4. Incidence of de novo or recurrent HCC
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients of chronic hepatitis B, acute hepatitis B, HBV carrier, past history of HBV infection, especially those who are undergoing immunosuppression or chemotherapy in Keio University Hospital.
Key exclusion criteria
Patients who refuse to participate or who are deemed inappropriate to participate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University
Division name
Gastroenterology and Hepatology, Internal Medicine, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi Sinjyuku-ku Tokyo
TEL
03-5363-3790
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Po-sung |
| Middle name | |
| Last name | Chu |
Organization
Keio University
Division name
Gastroenterology and Hepatology, Internal Medicine, School of Medicine
Zip code
160-8582
Address
35 Shinanomachi Sinjyuku-ku Tokyo
TEL
03-5363-3790
Homepage URL
pschu0928@iCloud.com
Sponsor or person
Institute
Gastroenterology and Hepatology, Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
IRB of School of Medicine, Keio University
Address
35 Shinanomachi Shinjyuku-ku Tokyo
Tel
03-3353-1211
keio@esct.bvits.com
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
| 2019 | Year | 12 | Month | 05 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 14 | 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
None
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044224
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
