UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030845 |
|---|---|
| Receipt number | R000035205 |
| Scientific Title | Analysis of clinical effects and safety of entecavir treatment to chronic hepatitis B patients; multicenter pilot study |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2018/06/22 17:35:58 |
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Basic information
Public title
Analysis of clinical effects and safety of entecavir treatment to chronic hepatitis B patients; multicenter pilot study
Acronym
Entecavir treatment to chronic hepatitis B patients; multicenter pilot study
Scientific Title
Analysis of clinical effects and safety of entecavir treatment to chronic hepatitis B patients; multicenter pilot study
Scientific Title:Acronym
Entecavir treatment to chronic hepatitis B patients; multicenter pilot study
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 antiviral effects and safety by entecavir treatment for chronic hepatitis B patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hepatocellular carcinoma, Progression of liver fibrosis, Reduction of serum markers (HBsAG, HBcrAg, M2BPGi), Safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
entecavir 0.5mg/day
Interventions/Control_2
no treatment
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
1. Chronic hepatitis B patients who had never been treated with any nucleot(s)ide analogues
2. Patients whose HBV DNA levels were less than 5 Log copies/ml at the baseline
3. Patients whose ALT levels were more than 31 U/L
4. Age: more than 20 y.o., Gender: unmentioned
5. Patients who can give written informed consent to participate in this study
Key exclusion criteria
1. Patients who have hypersensitivity to entecavir
2. Patients who have a renal dysfunction (eGFR<50mL/min/1.73m2) or who need hemodialysis due to chronic renal failure
3. Patients who have malignacies
4. Patients who were infected with both hepatitis B virus and the other viruses, such as human immunodeficiency virus or hepatitis C virus
5. Pregnant or lactating women or women who may be pregnant
6. Female patients who want pregnancy, Male patients who may be pregnant by pregnant women
7. Patients who was judged unreasonable to carry out this study by the research doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
Hiroshima university hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan.
TEL
082-257-5190
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Tsuge |
Organization
Hiroshima university hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan.
TEL
082-257-1728
Homepage URL
tsuge@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2018 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
