UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014271 |
|---|---|
| Receipt number | R000016612 |
| Scientific Title | Efficacy of PEG-IFN alpha-2a in the treatment of chronic Hepatitis B |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2014/06/16 07:02:16 |
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Basic information
Public title
Efficacy of PEG-IFN alpha-2a in the treatment of chronic Hepatitis B
Acronym
Treatment with Peg-interferon alpha-2a for chronic hepatitis B
Scientific Title
Efficacy of PEG-IFN alpha-2a in the treatment of chronic Hepatitis B
Scientific Title:Acronym
Treatment with Peg-interferon alpha-2a for chronic hepatitis B
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy of PEG-IFN alfa 2a with chronic Hepatitis B
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical stability rate after the treatment
Key secondary outcomes
Factors associated with clinical stabilization
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG-IFN alfa2a
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Hepatitis B
Key exclusion criteria
1.History of IFN or Nucleic acid analog use within 6 months
2.autoimmune hepatitis, alcoholic hepatitis, cirrhosis, hepatic failure
3.pregnacy, nursing mom
4.interstitial pneumonia
5.severe bone-marrow dysfunction, severe renal dysfunction, severe cardiac dysfunction, severe respiratory failure
6.HCC or other cancer
7.total bilirubin>2.0mg/dL,prothrombin activity<60%, Albumin<3.6 g/dL(more than 2 points)
8.Allergy for sitagliptin, nateglinide, liraglutide and exenatide
9.depression
10.Patients judged by the investigator to be ineligible for some other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Yasuhito |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Virology unit
Zip code
Address
Kawasumi, Mizuho, Nagoya 467-8601, Japan
TEL
052-842-8191
ytanaka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsui Takeshi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Virology unit
Zip code
Address
Kawasumi, Mizuho, Nagoya 467-8601, Japan
TEL
052-842-8191
Homepage URL
mtake0402@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
MHLW(JAPAN)
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 16 | Day |
Last modified on
| 2014 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016612
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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