UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007045
Receipt No. 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

* 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 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
Email 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
Email etanaka@shinshu-u.ac.jp

Sponsor
Institute Department of Medicine, Shinshu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.