UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004982 |
|---|---|
| Receipt number | R000005844 |
| Scientific Title | Investigation of intrahepatic hepatitis B virus (HBV) covalently closed circular (ccc) DNA of chronic hepatitis B patients whom neither serum hepatitis B e antigen nor HBV DNA has been detected for more than 6 months during oral antiviral therapy |
| Date of disclosure of the study information | 2011/01/31 |
| Last modified on | 2021/09/04 01:02:43 |
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Basic information
Public title
Investigation of intrahepatic hepatitis B virus (HBV) covalently closed circular (ccc) DNA of chronic hepatitis B patients whom neither serum hepatitis B e antigen nor HBV DNA has been detected for more than 6 months during oral antiviral therapy
Acronym
Investigation of intrahepatic HBV ccc DNA of chronic hepatitis B patients during oral antiviral therapy
Scientific Title
Investigation of intrahepatic hepatitis B virus (HBV) covalently closed circular (ccc) DNA of chronic hepatitis B patients whom neither serum hepatitis B e antigen nor HBV DNA has been detected for more than 6 months during oral antiviral therapy
Scientific Title:Acronym
Investigation of intrahepatic HBV ccc DNA of chronic hepatitis B patients during oral antiviral therapy
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 evaluate eradication of intrahepatic HBV ccc DNA as a predictor of sustained cirological response after cessation of oral antiviral dosing in patients whose serum HBeAg and HBV DNA are seronegative for more than 6 months.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Involvement of intrahepatic HBV ccc DNA eradication or remaining with viral reactivation after cessation of antiviral dosing
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronically HBV infected patients in whom neither serum hepatitis Be antigen nor HBV DNA has been detected for more than 6 month during oral antiviral therapy (lamivudine, entecavir, adefovir or both of thme).
Key exclusion criteria
liver cirrhosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshimichi |
| Middle name | |
| Last name | Haruna |
Organization
Osaka Prefectural General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Osaka
TEL
06-6692-1201
saito_yoshinobu@hotmail.com
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Saito |
Organization
Osaka Prefectual General Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
558-8558
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Osaka
TEL
06-6692-1201
Homepage URL
saito_yoshinobu@hotmail.com
Sponsor or person
Institute
Osaka Prefectual General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectual General Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Prefectual General Medical Center
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka, Osaka
Tel
06-6692-1201
apple-123-grape@ab.auone-net.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
| 2011 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
No protocol released
Publication of results
Unpublished
Result
URL related to results and publications
No results and publications
Number of participants that the trial has enrolled
0
Results
No patient enrolled
Results date posted
| 2021 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No patient enrolled
Participant flow
No patient enrolled
Adverse events
No patient enrolled
Outcome measures
No patient enrolled
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-sutained virological respnse
-intrahepatic HBV ccc DNA and total HBV DNA
-serum HBV DNA, hepatitis B e antigen and antibody, hepatits B c antibody(IgG, IgG)
-relationship between HBV ccc DNA and intrahepatic core-related antigen
Management information
Registered date
| 2011 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005844
