UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004906 |
|---|---|
| Receipt number | R000005842 |
| Scientific Title | Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B |
| Date of disclosure of the study information | 2011/01/19 |
| Last modified on | 2021/04/23 07:30:46 |
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Basic information
Public title
Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Acronym
Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Scientific Title
Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Scientific Title:Acronym
Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety, antiviral effect, clinical benefit of the entecavir and interferon sequencial therapy for withdrawal of entecavir with patients of chronic hepatitis B.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
maintenance of ALT
Key secondary outcomes
HBe antigen, anti-HBe
HBV DNA less than 4 log copies/mL
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
6 months of interferon or 6-12 months of peg-interferon treatment
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
patient with chronic hepatitis B treated with entecavir for more than 6 months.
Just before the trial, HBV DNA less than 2.1 log copies/mL, HBs antigen positive, HBe antigen negative, ALT 30 IU/L or less, platelet count 150,000/µL or more
Non-cirrhosis
Without hepatocellular carcinoma
Key exclusion criteria
1,allergy with entecavir, interferon or vaccination
2,interferon treatment before 6 months of the trial
3,pregnancy or lactation period
4,severe heart disease, chronic renal failure, depression, severe psychotic disease, liver cirrhosis, brain hemorrhage or infarction, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, HCV infection, autoimmune disease
5,treated with shosaiko-to
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Yasunaka |
Organization
Okayama university hosipital
Division name
Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7219
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
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
| 2011 | Year | 01 | Month | 19 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
