UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012454 |
|---|---|
| Receipt number | R000014573 |
| Scientific Title | PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir |
| Date of disclosure of the study information | 2013/12/05 |
| Last modified on | 2017/09/11 23:33:16 |
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Basic information
Public title
PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir
Acronym
PegIFNalpha-2a treatment added-on entecavir
Scientific Title
PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir
Scientific Title:Acronym
PegIFNalpha-2a treatment added-on entecavir
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The reduction of HBsAg levels during peg interferon added on entecavir
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The reduction of HBsAg and the number of patients who achieve >0.5 log U/mL at 48 weeks after randomization
Key secondary outcomes
1) The change of HBsAg levels at 1Y, 2Y and 3Y after peg interferon add-on treatment
2) Clearance rates of HBsAg and rates of < 100 U/mL or <1000 U/mL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peg interferon therapy added-on entecavir
Interventions/Control_2
Entecavir mono therapy
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
Entecavir-treated (more than 1 year) CHB patients met the following criteria,
1) HBsAg-positive
2) HBeAg-negative
3) HBV DNA-undetectable (continuous undetection for more than 1 year)
Key exclusion criteria
1) Patients receiving Chinese herb (sho-sai-ko-to)
2) Patients with history of interstitial pneumonia
3) Patients with auto immune hepatitis
4) Patients with hypersensitivity to interferon
5) Patients with hypersensitivity to biological agents
6) Patients with neutropenia (<1500/mm3), thrombocytopenia (<90000/mm3), or anemia (Hb<12g/dL)
7) Cirrhotic patients
8) Patients with history of HCC
9) Doctors consider inadequate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Kumada |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL
044-877-5111
kumahiro@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Hosaka |
Organization
Toranomon Hospital
Division name
Hepatology
Zip code
Address
1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL
044-877-5111
Homepage URL
hosa-p@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
札幌厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 05 | 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 | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
