UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061074 |
|---|---|
| Receipt number | R000069404 |
| Scientific Title | Multicenter Study on Quality Of Life and Treatment Compliance in Patients with Chronic Hepatitis B |
| Date of disclosure of the study information | 2026/03/27 |
| Last modified on | 2026/03/27 11:19:47 |
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Basic information
Public title
Multicenter Study on Quality Of Life and Treatment Compliance in Patients with Chronic Hepatitis B
Acronym
INSIGHT-HBV Study
Scientific Title
Multicenter Study on Quality Of Life and Treatment Compliance in Patients with Chronic Hepatitis B
Scientific Title:Acronym
INSIGHT-HBV Study
Region
| Japan |
Condition
Condition
Hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate differences in health-related quality of life (HRQOL) based on the use and type of nucleoside/nucleotide analog agents among patients with chronic hepatitis B virus (HBV) infection.
Basic objectives2
Others
Basic objectives -Others
Identify factors associated with medication adherence in chronic HBV patients, barriers and facilitators to long-term adherence, and the relationship between communication between patients and healthcare providers and treatment satisfaction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chronic Liver Disease Questionnaire (CLDQ)-HBV
Key secondary outcomes
Patient-Reported Treatment Experience Questionnaire
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Disease Name: Hepatitis B virus carrier, chronic hepatitis B, hepatitis B cirrhosis
(2) Regardless of disease stage
(3) Individuals who have provided appropriate consent for study participation
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Inoue |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7171
jun.inoue.d8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Hospital
Division name
Department of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7171
Homepage URL
kousuke.satou.e5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院（宮城県）
旭川医科大学病院（北海道）
北海道大学病院（北海道）
岩手医科大学附属病院（岩手県）
秋田大学医学部附属病院（秋田県）
山形大学医学部附属病院（山形県）
福島県立医科大学附属病院（福島県）
石巻赤十字病院（宮城県）
東北労災病院（宮城県）
仙台医療センター（宮城県）
仙台市立病院（宮城県）
みやぎ県南中核病院（宮城県）
いわき市医療センター（福島県）
JR仙台病院（宮城県）
仙台赤十字病院（宮城県）
JCHO仙台南病院（宮城県）
栗原中央病院（宮城県）
JCHO仙台病院（宮城県）
気仙沼市立病院（宮城県）
岩手県立胆沢病院（岩手県）
塩竈市立病院（宮城県）
青森県立中央病院（青森県）
十和田市立中央病院（青森県）
岩手県立中部病院（岩手県）
坂総合病院（宮城県）
八戸市立市民病院（青森県）
総合南東北病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adult patients who are HBs antigen positive are eligible, regardless of whether they are currently receiving NA therapy. Participants will access the online questionnaire via QR code using their own smartphones or other devices. For patients who have difficulty accessing it independently, they will access the online questionnaire from within the facility using tablet devices loaned to each facility. Paper responses will be permitted only when online response is difficult.
The survey includes the Chronic Liver Disease Questionnaire (CLDQ)-HBV and a patient-reported treatment experience questionnaire. The CLDQ-HBV is used to quantitatively assess the impact of chronic hepatitis B on patients' daily lives, while the patient-reported treatment experience questionnaire aims to understand patients' subjective treatment experiences and medication adherence challenges in real-world clinical settings. Questions also cover concomitant medication use, medication adherence, communication with healthcare providers, and sociodemographic factors. Medication adherence is assessed using the Morisky Medication Adherence Scale (MMAS)-8 questionnaire and the Medication Possession Ratio (MPR) method based on prescriptions. In addition to survey responses, clinical data such as liver disease stage, alanine aminotransferase (ALT) levels, HBV DNA levels, and presence of hepatocellular carcinoma (HCC) will be obtained from medical records.
All data will be anonymized, and statistical analyses will be performed to identify factors related to QOL and medication adherence, including the effects of treatment regimens and disease progression.
Management information
Registered date
| 2026 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069404
