UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000808 |
|---|---|
| Receipt number | R000000862 |
| Scientific Title | Efficacy of entecavir/IFN alpha sequential therapy for HBeAg-positive chronic active hepatitis B |
| Date of disclosure of the study information | 2011/09/30 |
| Last modified on | 2012/08/24 12:29:45 |
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Basic information
Public title
Efficacy of entecavir/IFN alpha sequential therapy for HBeAg-positive chronic active hepatitis B
Acronym
Entecavir/IFN sequential therapy for chronic hepatitis B (B-SHOT study)
Scientific Title
Efficacy of entecavir/IFN alpha sequential therapy for HBeAg-positive chronic active hepatitis B
Scientific Title:Acronym
Entecavir/IFN sequential therapy for chronic hepatitis B (B-SHOT study)
Region
| Japan |
Condition
Condition
HBeAg-positive chronic active hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of entecavir/IFN alpha sequential therapy in patients with HBeAg-positive chronic active hepatitis B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
negative HBeAg, undetectable HBV DNA and normal ALT at month 6 after the end of therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
When HBeAg is negative at month 11 of 0.5mg entecavir therapy, patients will be randomly assigned to receive one of two regimens; in Group A, patients will receive entecavir alone for 7 more months
Interventions/Control_2
When HBeAg is negative at month 11 of 0.5mg entecavir therapy, patients will be randomly assigned to receive one of two regimens; in Group B, patients will receive entecavir alone for one more month, then both IFN alpha 5MU (trice weekly) and entecavir for one month, and lastly IFN alpha alone for 5 months.
Interventions/Control_3
When HBeAg is positive at month 11 of 0.5mg entecavir therapy (Group C), patients will receive entecavir alone for one more month, then both IFN alpha 5MU (trice weekly) and entecavir for one month, and lastly IFN alpha alone for 5 months.
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
1. persistent or fluctuating elevations of serum ALT for at least 6 months
2. positive HBeAg
3. detectable HBV DNA
Key exclusion criteria
1. use of lamivudine or any other antiviral agents for hepatitis B within 3 months before the start of therapy
2. presence of lamivudine-resistant YMDD variants
3. clinical signs of decompensated cirrhosis or liver failure
4. other likely causes of chronic liver disease
5. severe complication (poor renal, cardiac, or respiratory function)
6. women who are possibly pregnant, expectant mothers, and lactating mothers
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Enomoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 24 | Day |
Last modified on
| 2012 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000862
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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