UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015633 |
|---|---|
| Receipt number | R000018171 |
| Scientific Title | Assessment of efficacy and safety of PEG-IFN alpha-2a administration into patients with chronic hepatitis B on nuleoside analogue |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2025/02/15 15:17:33 |
* 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
Assessment of efficacy and safety of PEG-IFN alpha-2a administration into patients with chronic hepatitis B on nuleoside analogue
Acronym
Usefulness of PEG-IFN alpha-2a treatment in combination with nucleoside analogue
Scientific Title
Assessment of efficacy and safety of PEG-IFN alpha-2a administration into patients with chronic hepatitis B on nuleoside analogue
Scientific Title:Acronym
Usefulness of PEG-IFN alpha-2a treatment in combination with nucleoside analogue
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify usefulness of PEG-IFN alpha-2a administration into into patients with chronic hepatitis B on nucleoside analogue
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Amount of HBs antigen at 12, 24, and 48 weeks after starting PEG-IFN alpha-2a administration
2. HBs antigen status for five years after stopping PEG-IFN alpha-2a administration
Key secondary outcomes
1. ALT and AFP levels after after starting PEG-IFN alpha-2a administration
2. Incidence of hepatocellular carcinoma
3. Pharmacoeconomics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
48-week PEG-IFN alpha-2a treatment for patients with chronic hepatitis B on nucleoside analogue
Interventions/Control_2
Pursue nucleoside analogue treatment for patients with chronic hepatitis B, without PEG-IFN alpha-2a administration
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 with chronic hepatitis B who have been treated with nucleoside analogue
2. Patients whose informed consent was obtained
Key exclusion criteria
1. Patients with advance liver fibrosis
2. Patients with other serious diseases
3. Women who are pregnant or those who have a possibility to be pregnant.
4. Patients who have a contra-indication for receiving PEG-IFN alpha-2a treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KENGO TOMITA |
Organization
National Defense Medical College
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Namiki 3-2, Tokorozawa-shi, Saitama
TEL
04-2995-1609
kengo@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KENGO TOMITA |
Organization
National Defense Medical College
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Namiki 3-2, Tokorozawa-shi, Saitama
TEL
04-2995-1609
Homepage URL
kengo@ndmc.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
None
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
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
防衛医科大学校病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018171
