UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003982 |
|---|---|
| Receipt number | R000004798 |
| 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 |
| Date of disclosure of the study information | 2010/08/03 |
| Last modified on | 2020/03/31 17:43:05 |
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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
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
he-jishu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College Of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004798
