UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004906
Receipt No. R000005842
Scientific Title Open trial of the interferon therapy for withdrawal of entecavir for patient with chronic hepatitis B
Date of disclosure of the study information 2011/01/19
Last modified on 2012/01/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
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
2012 Year 01 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.