UMIN-CTR Clinical Trial

Basic information
Public title	Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Acronym	Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Scientific Title	Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Scientific Title:Acronym	Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
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 the safety, antiviral effect, clinical benefit of the entecavir and interferon sequencial therapy for withdrawal of entecavir with patients of chronic hepatitis B.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	maintenance of ALT
Key secondary outcomes	HBe antigen, anti-HBe HBV DNA less than 4 log copies/mL

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	6 months of interferon or 6-12 months of peg-interferon treatment
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patient with chronic hepatitis B treated with entecavir for more than 6 months. Just before the trial, HBV DNA less than 2.1 log copies/mL, HBs antigen positive, HBe antigen negative, ALT 30 IU/L or less, platelet count 150,000/&#181;L or more Non-cirrhosis Without hepatocellular carcinoma
Key exclusion criteria	1,allergy with entecavir, interferon or vaccination 2,interferon treatment before 6 months of the trial 3,pregnancy or lactation period 4,severe heart disease, chronic renal failure, depression, severe psychotic disease, liver cirrhosis, brain hemorrhage or infarction, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, HCV infection, autoimmune disease 5,treated with shosaiko-to
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuya Yasunaka
Organization	Okayama university hosipital
Division name	Gastroenterology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7219
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
Homepage URL
Email

Sponsor
Institute	Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 01 Month 19 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	Completed
Date of protocol fixation	2011 Year 01 Month 01 Day
Date of IRB	2011 Year 01 Month 01 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 01 Day
Date trial data considered complete	2014 Year 12 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2011 Year 01 Month 19 Day
Last modified on	2021 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005842