UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013811 |
|---|---|
| Receipt number | R000016121 |
| Scientific Title | Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2014/04/25 14:05:01 |
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Basic information
Public title
Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B
Acronym
Sequential therapy with chronic hepatitis B
Scientific Title
Effect of nucleosid analog and peginterferon alfa 2a sequential therapy on patients with chronic hepatitis B
Scientific Title:Acronym
Sequential therapy with chronic hepatitis B
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination about the ability of drug free to be attained by performing 48 weeks of interferon medication, and a (sequential treatment) for B type chronic hepatitis patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
drug free
ALT<40 HBV-DNA<5.0Log/ml
Key secondary outcomes
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
peginterferon-alpha2a
entecavir
adefovir dipivoxil
lamivudine
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who the nucleic acid analog tablet for 48 or more weeks (entecavir
Adefovir dipivoxil,Lamivudinele) is having medication continued, and presents HBV DNA negativity(less than 2.6 log copy/mL) to B type chronic hepatitis
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
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miwa Kawanaka |
Organization
Kawasaki Medical school
Division name
General Internal Medicine2
Zip code
Address
2-1-80,Nakasange,Okayamacity Okayama,JAPAN
TEL
086-225-2111
m.kawanaka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Kawanaka |
Organization
Kawasaki Medical school
Division name
General Internal Medicine2
Zip code
Address
2-1-80,Nakasange,Okayamacity Okayama,JAPAN
TEL
086-225-2111
Homepage URL
m.kawanaka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
General Internal Medicine2
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 27 | 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
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2014 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016121
