UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000393 |
|---|---|
| Receipt number | R000000484 |
| Scientific Title | Entecavir for the treatment of breakthrough hepatitis caused by lamivudine and adefovir dipivoxil-resistant mutants of hepatitis B virus |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2015/08/30 10:44:16 |
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Basic information
Public title
Entecavir for the treatment of breakthrough hepatitis caused by lamivudine and adefovir dipivoxil-resistant mutants of hepatitis B virus
Acronym
GLSG, 2006, entecavir
Scientific Title
Entecavir for the treatment of breakthrough hepatitis caused by lamivudine and adefovir dipivoxil-resistant mutants of hepatitis B virus
Scientific Title:Acronym
GLSG, 2006, entecavir
Region
| Japan |
Condition
Condition
chronic hepaittis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of entecavir for the patients with chronic hepatitis B with severe acute exacerbation of hepatitis caused by lamivudine and adefovir dipivoxil-resistant mutants
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
HBV-DNA
Key secondary outcomes
Serum ALT
side effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Baraclude (entecavir) 1mg/day p.o.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic hepatitis B
Lamivudine and Adefovir dipivoxil-resistant mutants
abnormal ALT
positive test of HBV-DNA
Key exclusion criteria
Allergy to Lamivudine
complication of chronic hepatitis
coadministration of cytotoxic drugs
leucopenia
during pregnancy
severe liver dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-15 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-15 Showa, Maebashi, Gunma 371-8511
TEL
027-220-8127
Homepage URL
satoken@showa.gunma-u.ac.jp
Sponsor or person
Institute
Gunma Liver Study Group (GLSG)
Institute
Department
Personal name
Funding Source
Organization
Gunma Liver Study Group (GLSG)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000484
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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