UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009159 |
|---|---|
| Receipt number | R000010742 |
| Scientific Title | Randomised clinical trial of interferon rebound therapy for chronic hepatitisB patients |
| Date of disclosure of the study information | 2012/10/21 |
| Last modified on | 2012/10/21 16:55:11 |
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Basic information
Public title
Randomised clinical trial of interferon rebound therapy for chronic hepatitisB patients
Acronym
Interferon rebound therapy for chronic hepatitisB patients
Scientific Title
Randomised clinical trial of interferon rebound therapy for chronic hepatitisB patients
Scientific Title:Acronym
Interferon rebound therapy for chronic hepatitisB patients
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safty of interferon rebound therapy for chronic hepatitisB patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HBe seroconversion and the suppression of HBV DNA levels to below 5.0Log copies/ml and the normalization of alanine aminotransferase levels at 24 weeks treatment of interferon therapy or Nucleoside analogue therapy
Key secondary outcomes
HBe seroconversion and undetectable HBV DNA and normalization of alanine aminotransferase levels and negative HBeAg and negative HBsAg and HBs seroconversion and HBsAg and HBcrAg
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Patient who obtains agreement for participation in present study
(2) Aminotransferase level >=31IU/L
(3)HBeAg-positive and HBV DNA levels >= 5 log IU/mL
Key exclusion criteria
(1)Cirrhosis or hepatic failure such as chronic liver diseases, e.g. autoimmune hepatitis and alcoholic hepatitis
(2)History of pneumonitis
(3) Severe other diseases
(4)Severe mental disorders
(5)Pregnant woman or woman who has possibility of pregnancy or woman while suckling
(6)Doctor judged patient as inappropriate person in this trial
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
Department of Hepatology
Zip code
Address
1-3-1, Kajigaya, Takatsu-ku, Kawasaki 213-8587, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Suzuki |
Organization
Toranomon Hospital
Division name
Department of Hepatology
Zip code
Address
1-3-1, Kajigaya, Takatsu-ku, Kawasaki 213-8587, Japan
TEL
044-877-5111
Homepage URL
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
| 2012 | Year | 10 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Parallel
Randomized
Open -no one is blinded
Management information
Registered date
| 2012 | Year | 10 | Month | 21 | Day |
Last modified on
| 2012 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010742
