UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030845
Receipt No. 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

* 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 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
Email 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
Email tsuge@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university hospital
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


Contact us.