UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000898 |
|---|---|
| Receipt number | R000000923 |
| Scientific Title | A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients whose HBV DNA levels are below the level of detection by PCR |
| Date of disclosure of the study information | 2007/11/17 |
| Last modified on | 2013/12/21 18:56:42 |
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Basic information
Public title
A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients whose HBV DNA levels are below the level of detection by PCR
Acronym
LAM plus ADV vs ETV for HBV patients treated with LAM, randomized trial
Scientific Title
A comparison of lamivudine plus adefovir and entecavir for chronic hepatitis B patients whose HBV DNA levels are below the level of detection by PCR
Scientific Title:Acronym
LAM plus ADV vs ETV for HBV patients treated with LAM, randomized trial
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 efficacy and safety of adding adefovir dipivoxil on lamivudine or entecavir monotherapy in patients with chronic hepatitis B whose HBV DNA levels are below the level of detection by PCR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
an incidence of resistant hepatitis B virus to both LAM and ADV, or ETV at 2 and 5 years
Key secondary outcomes
normalization of the alanine aminotransferase level
a reduction in the serum HBV DNA level
HBeAg loss and seroconversion
an incidence of hepatocellular carcinoma
five-year survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lamivudine/Adefovir group
Lamivudine 100mg is administered orally once daily. When resistant virus is appearance or lamivudine is not insufficient, patients are added 10mg of adefovir dipivoxil once daily on lamivudine.
Interventions/Control_2
Entecavir group
Entecavir 0.5mg is administered orally once daily.
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
The study is designed to enroll patients with HBsAg positive.
Other eligibility criteria includes: Eastern Chemotherapy Oncology Group(ECOG)performance status of 0-2,
administered lamivudine and no prior adefovir dipivoxil therapy,
HBV DNA levels less than the detection level by PCR.
Written informed consent is required from all patients.
Key exclusion criteria
The exclusion criteria are as follows:
a previous history of a severe drug hypersensitivity against nucleoside analogues,
malignancy within 5 years,
severe renal disease (BUN more than 40 mg/dl or creatinine more than 2.0 mg/dl)
the presence of other forms of
liver disease such as auto immune hepatitis, coinfection with hepatitis C,
history of liver transplantation,
participation in another clinical trial,
receiving prohibition medication for combination, and
doctors' stop not to register to the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Yoshida |
Organization
University of Tokyo
Division name
Department of Gastroenterology, Faculty of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
yoshida-2im@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Goto |
Organization
University of Tokyo
Division name
Department of Gastroenterology, Faculty of Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
tadagotou-gi@umin.ac.jp
Sponsor or person
Institute
University of Tokyo
Department of Gastroenterology, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2007 | Year | 11 | Month | 17 | 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
| 2007 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 16 | Day |
Last modified on
| 2013 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000923
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| Registered date | File name |
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