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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001120
Receipt No. 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

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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
Email

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
Email ytanaka@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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