UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized trial of lamivudine continuous therapy and entecavir switching therapy for chronic hepatitis B patients treated with lamivudine monotherapy
Title of the study (Brief title)	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	Masashi Misokami
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Clinical Molecular Informative Medicine
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL	052-851-5511
Email

Public contact
Name of contact person	Yasuhito Tanaka
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Clinical Molecular Informative Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 03 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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