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

Email

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/

Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name