UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy
Acronym	Compare the value of increased dose to combination therapy with nucleoside analogues
Scientific Title	Randomized control trial of increased dose therapy with Entecavir vursus combination therapy with Entecavir and Adefovir in CHB patients with inadequate nucleoside analogue therapy
Scientific Title:Acronym	Compare the value of increased dose to combination therapy with nucleoside analogues
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the antiviral efficacy of increased dose therapy with Entecavir and combination therapy with Entecavir and Adefovir on inadequate nucleoside analogue therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of HBcrAg, HBsAg
Key secondary outcomes	safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Entecavir 0.5mg/day + Adefovir 10mg/day
Interventions/Control_2	Entecavir 1.0mg/day
Interventions/Control_3	Entecavir 0.5mg/day
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	37 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic hepatitis B Entecavir 0.5mg/day HBV DNA positive HBcrAg >=4.0 Log IU/ml HBsAg >=1000IU/ml
Key exclusion criteria	1. Resistant to Entecavir 2. Intolerance to Entecavir 3. Pregnant, lactating women 4. Possibly pregnant women 5. Chronic kidney failure 6. Creatinine clearance of <=50 mL/ min 7. Severe heart diseases 8. Decompensated liver cirrhosis 9. Liver transplant patient 10. HIV/HBV superinfection
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuhei Nishiguchi
Organization	Hyogo College Of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL	0798-45-6472
Email

Public contact
Name of contact person	1st name Middle name Last name Masaki Saito
Organization	Hyogo College Of Medicine
Division name	Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL	0798-45-6472
Homepage URL
Email	he-jishu@hyo-med.ac.jp

Sponsor
Institute	Hyogo College Of Medicine
Institute
Department

Funding Source
Organization	Hyogo College Of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Wakakoukai clinic
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	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 03 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	Terminated
Date of protocol fixation	2010 Year 05 Month 18 Day
Date of IRB	2010 Year 06 Month 04 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2014 Year 05 Month 01 Day
Date of closure to data entry	2014 Year 08 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 08 Month 02 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004798