UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029439 |
|---|---|
| Receipt number | 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 | 2022/03/10 14:55:01 |
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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 | Goki |
| Middle name | |
| Last name | Suda |
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
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Goki |
| Middle name | |
| Last name | Suda |
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/
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Institute
Department
Personal name
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
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
| 2022 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033638
