UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001120 |
|---|---|
| Receipt number | R000001361 |
| Scientific Title | A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy |
| Date of disclosure of the study information | 2008/04/16 |
| Last modified on | 2017/11/14 12:07:36 |
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Basic information
Public title
A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy
Acronym
LVD countinuous therapy vs. ETV switching therapy for CHB patients treated with LVD, randomized trial
Scientific Title
A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy
Scientific Title:Acronym
LVD countinuous therapy vs. ETV switching therapy for CHB patients treated with LVD, randomized trial
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a randomized clinical trial,
to evaluate the efficacy and safety of lamivudine continuous therapy compared with entecavir swithing therapy for chronic hepatitis B patients who have undetectable HBV DNA during lamivudine
monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the following factors after the two-year therapy by LVD or ETV.
1) An incidence of HBV-DNA negative
2) The rate of ALT normalization
3) An incidence of HBeAg seroconversion
4) An incidence of virological breakthrough
5) An incidence of breakthrough hepatitis
Key secondary outcomes
1) Existence of resistant HBV to LVD at the entry
2) An incidence of genotypic resistance
a. an incidence of resistant HBV to LVD
b. an incidence of resistant HBV to ETV
3) HBV genotype
4) HB core related antigen (HBcrAg)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LVD group:
Lamivudine 100mg is administered orally once daily. When breakthrough hepatitis is developed by resistant virus to LVD, patients are added 10mg of adefovir dipivoxil once daily on lamivudine.
Interventions/Control_2
ETV group:
ETV 0.5mg is administered orally once daily. When breakthrough hepatitis is developed by resistant virus to ETV, 100mg of lamivudine and 10mg of adefovir dipivoxil once daily are administered.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>Chronic hepatitis B patient with HBsAg positive.(include hepatitis B patients with compensated cirrhosis)
>Age; more than 20 years.
>LVD has been administered.
>In addition, following conditions ((1) or (2)) are required.
(1) Administration of LVD; less than 3 years, The levels of HBV DNA; less than 2.6log by Amplicor PCR.
(2) Administration of LVD; more than 3 years, The levels of HBV DNA; less than 2.6log by Amplicor PCR.
Key exclusion criteria
1) Concomitant medication of nucleoside analogues except for LVD at present.
2) Concomitant medication of IFN.
3) Concomitant medication of immunosuppressant.
4) HBsAb positive patients.
5) Patients with HCC or other malignancy.
6) Patients with decompensated cirrhosis.
7) Pregnant (or possible) women.
8) Patients with under breast feeding.
9) Co-infection with HIV or HCV
10) Other conditions considered inappropriate by attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Misokami |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Clinical Molecular Informative Medicine
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Tanaka |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Clinical Molecular Informative Medicine
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-851-5511
Homepage URL
ytanaka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
| 2008 | Year | 04 | Month | 16 | 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
| 2008 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | 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
| 2008 | Year | 04 | Month | 15 | Day |
Last modified on
| 2017 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001361
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| Registered date | File name |
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