UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018701 |
|---|---|
| Receipt number | R000016459 |
| Scientific Title | Prediction of the emergence of HBV mutant by the antiviral treatment by using next-generation sequencer |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2015/09/17 13:41:51 |
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Basic information
Public title
Prediction of the emergence of HBV mutant by the antiviral treatment by using next-generation sequencer
Acronym
Analysis of the HBV mutant by using next-generating sequencer
Scientific Title
Prediction of the emergence of HBV mutant by the antiviral treatment by using next-generation sequencer
Scientific Title:Acronym
Analysis of the HBV mutant by using next-generating sequencer
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We attempt to detect several HBV mutant clones, which have already existed before anti-viral drug treatment by using a next-generation sequencer in order to clarify the relation between the curative effect by an anti-viral drug treatment and HBV mutant clones.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the rate of the wild and mutant strain before medical treatment, and the rate of each stock under medical treatment
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic hepatitis B
(1) Patients who obtained the document, the consent to participate in research in the description
(2)Patients who do not belong to the exclusion criteria
Key exclusion criteria
(1) the patients who are not detect HBVDNA in peripheral blood
(2) the patients who cannot consult our department periodically
(3) the patients who are not appropriate to entry for this examination by doctors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Murakami |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
81-6-6645-3811
yoshimurak@med.osaka-cu.au.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Murakami |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
81-6-6645-3811
Homepage URL
m2979633@med.osaka-cu.au.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2015 | Year | 08 | Month | 17 | Day |
Last modified on
| 2015 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016459
