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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029439
Receipt No. R000033638
Scientific Title The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Date of disclosure of the study information 2017/10/06
Last modified on 2019/03/27

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Basic information
Public title The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Acronym The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Scientific Title The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Scientific Title:Acronym The analysis of factor involved in decreased HBsAg in HBV patients treated with nucleos(t)ide analogue
Region
Japan

Condition
Condition Chronic hepatitis B virus infected patient
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To analyze the degree of HBsAg decline after administration of nucleos(t)ide analugues, and to investigate the associated factor of HBsAg decline
Basic objectives2 Others
Basic objectives -Others To analyze the degree of HBsAg decline after administration of nucleos(t)ide analugues, and to investigate the associated factor of HBsAg decline
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The degree of HBV-DNA and HBsAg decline 1 year after administration of nucleos(t)ide analugues
Key secondary outcomes 1. The degree of HBV-DNA and HBsAg decline 3, 5, 10 years after administration of nucleos(t)ide analugues
2. Relevalence between IL28B SNPs and HBsAg decline
3. Relevalence between serum IFN-lambda3 and HBsAg decline
4. Relevalence between emergence of resistant associated variant and antiviral effect
5. efficacy of improvement of hepatic fibrosis
6. efficacy of improvement of AST/ALT

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. Patients who are 20 years of age or older at the time of obtaining informed consent
2. Patients who are informed and have provided written informed consent to participate in the study prior to study initiation
3. Patients with chronic HBV who do not meet any of the following exclusion criteria
4. Patients receiving nucleos(t)ide analogues or plan to be treated with nucleos(t)ide analogues
Key exclusion criteria 1. Patients with difficult to manage cardiac disease
2. Patients who have a history of allergic reaction by nucleos(t)ide analogues
3. Patients treated with contraindicated drug together with nucleos(t)ide analogues
4. Patients by whom doctor in charge has determined to be inappropriate as a subject
5. Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Morikawa
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 060-8648
Address Kita15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL 011-716-1161
Email kenichi.morikawa@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Morikawa
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 060-8648
Address Kita15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido, Japan
TEL 011-716-1161
Homepage URL http://halo.med.hokudai.ac.jp/group/-/hepatology/
Email kenichi.morikawa@med.hokudai.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7636
Email crjimu@huhp.hokudai.ac.jp

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 06 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 15 Day
Date of IRB
2017 Year 06 Month 14 Day
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
2033 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information an observational study with CHB treated with NAs

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033638

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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