UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of clinical effects and safety of entecavir treatment to chronic hepatitis B patients; multicenter pilot study
Title of the study (Brief title)	Entecavir treatment to chronic hepatitis B patients; multicenter pilot study
Region	Japan

Condition
Condition	Chronic hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of antiviral effects and safety by entecavir treatment for chronic hepatitis B patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of hepatocellular carcinoma, Progression of liver fibrosis, Reduction of serum markers (HBsAG, HBcrAg, M2BPGi), Safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	entecavir 0.5mg/day
Interventions/Control_2	no treatment
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	1. Chronic hepatitis B patients who had never been treated with any nucleot(s)ide analogues 2. Patients whose HBV DNA levels were less than 5 Log copies/ml at the baseline 3. Patients whose ALT levels were more than 31 U/L 4. Age: more than 20 y.o., Gender: unmentioned 5. Patients who can give written informed consent to participate in this study
Key exclusion criteria	1. Patients who have hypersensitivity to entecavir 2. Patients who have a renal dysfunction (eGFR<50mL/min/1.73m2) or who need hemodialysis due to chronic renal failure 3. Patients who have malignacies 4. Patients who were infected with both hepatitis B virus and the other viruses, such as human immunodeficiency virus or hepatitis C virus 5. Pregnant or lactating women or women who may be pregnant 6. Female patients who want pregnancy, Male patients who may be pregnant by pregnant women 7. Patients who was judged unreasonable to carry out this study by the research doctors
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuaki Chayama
Organization	Hiroshima university hospital
Division name	Department of Gastroenterology and Metabolism
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan.
TEL	082-257-5190
Email	chayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Masataka Tsuge
Organization	Hiroshima university hospital
Division name	Department of Gastroenterology and Metabolism
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan.
TEL	082-257-1728
Homepage URL
Email	tsuge@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 01 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 12 Day
Anticipated trial start date	2018 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 17 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035205