UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007045 |
|---|---|
| Receipt number | R000008285 |
| Scientific Title | Study on usefulness of PEG-IFN alpha-2a administration to discontinue nucleos(t)ide analogue treatment in patients with chronic hepatitis B |
| Date of disclosure of the study information | 2012/01/10 |
| Last modified on | 2017/07/15 09:57:29 |
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Basic information
Public title
Study on usefulness of PEG-IFN alpha-2a administration to discontinue nucleos(t)ide analogue treatment in patients with chronic hepatitis B
Acronym
Usefulness of PEG-IFN alpha-2a to discontinue NA treatment
Scientific Title
Study on usefulness of PEG-IFN alpha-2a administration to discontinue nucleos(t)ide analogue treatment in patients with chronic hepatitis B
Scientific Title:Acronym
Usefulness of PEG-IFN alpha-2a to discontinue NA treatment
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify usefulness of PEG-IFN alpha-2a administration to discontinue NA treatment in patients with chronic hepatitis B
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HBe antigen status, amount of HBV DNA, and ALT level at 24 and 48 weeks after stopping PEG-IFN administration.
Key secondary outcomes
1. HBe antigen status, amount of HBV DNA, and ALT level at 24 weeks after stopping PEG-IFN administration.
2. Changes in amount of viral antigens including HBs antigen during and after PEG-IFN administration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Start PEG-IFN alpha 2a administration just after stopping NA.
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 with chronic hepatitis B who have been treated with NA for more than one years.
2. Patients who understand a risk of hepatitis relapse after stopping NA.
3. Patients who can be followed properly after stopping NA.
4. Patients whose informed consent was obtained.
Key exclusion criteria
1. Patients with impaired liver function.
2. Patients with advance liver fibrosis.
3. Patients with other serious diseases.
4. Women who are pregnant or those who have a possibility to be pregnant.
5. 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 | EIJI TANAKA |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano-ken
TEL
0263-37-2634
etanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | EIJI TANAKA |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano-ken
TEL
0263-37-2634
Homepage URL
etanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Medicine, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Division of Hepatobiliary and Pancreatic Medicine, Hyogo College of Medicine
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
信州大学医学部附属病院（長野県）、兵庫医科大学病院（兵庫県）、千葉大学医学部附属病院（千葉県）、聖マリアンナ医科大学病院（神奈川県）、名古屋市立大学病院（愛知県）、長崎医療センター（長崎県）、大阪市立大学医学部附属病院（大阪府）、大阪医科大学附属病院（大阪府）、東海大学医学部附属病院（神奈川県）、岡山大学病院（岡山県）、
川崎医科大学附属病院（岡山県）、広島大学病院（広島県）、手稲渓仁会病院（北海道）、武蔵野赤十字病院（東京都）、山形大学医学部附属病院（山形県）、横浜市立大学附属病院（神奈川県）、くまもと森都総合病院（熊本県）、熊本大学医学部附属病院（熊本県）、福岡大学病院（福岡県）、虎の門病院（東京都）、山梨大学医学部附属病院（山梨県）、香川県立中央病院（香川県）、大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28634723
Number of participants that the trial has enrolled
Results
BACKGROUND: This prospective cohort study searched for factors associated with a response to nucleos(t)ide analogue/peg-interferon (NUC/peg-IFN) sequential therapy. METHODS: A total of 95 patients with chronic hepatitis B being treated with NUCs were enrolled. Immediately following NUC cessation, peg-IFN was administered at 180 microg/dose weekly for 48 weeks. RESULTS: Twenty-six patients (27%) were judged to be responders at 48 weeks after the completion of peg-IFN. Analysis of baseline factors revealed that hepatitis B surface antigen (HBsAg) <3.1 log IU/ml and HB core-related antigen (HBcrAg) <3.9 log U/ml were significant indicators of a treatment response. The levels of the markers decreased in both responders and non-responders during peg-IFN therapy but continued falling in responders only after halting peg-IFN. Lower HBsAg (<2.0 log IU/ml) and HBcrAg (<3.8 log U/ml) levels at the time of response judgment were also significantly associated with a favorable response. While lower HBcrAg at baseline was the sole predictor of decreased HBcrAg levels at judgment, lower HBsAg, lower HBcrAg, and the use of adefovir dipivoxil at baseline predicted decreased HBsAg levels at the study endpoint. The use of adefovir dipivoxil was also associated with higher serum IFN-lambda3, which might have contributed to the reduction in patient HBsAg levels. CONCLUSIONS: The combinational use of HBsAg and HBcrAg levels at baseline and their changes throughout sequential therapy may be useful for predicting a response to NUC/peg-IFN sequential therapy.
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
| 2012 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 10 | Day |
Last modified on
| 2017 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008285
