UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000313 |
|---|---|
| Receipt number | R000000405 |
| Scientific Title | A dose comparing study of peginterferon alfa-2b plus ribavirin in chronic hepatitis type C except genotype 1 and high pretreatment viremia.: A randomized open-label pilot study. |
| Date of disclosure of the study information | 2006/01/27 |
| Last modified on | 2012/06/13 16:27:00 |
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Basic information
Public title
A dose comparing study of peginterferon alfa-2b plus ribavirin in chronic hepatitis type C except genotype 1 and high pretreatment viremia.: A randomized open-label pilot study.
Acronym
peginterferon alfa-2b plus ribavirin combination therapy for chronic hepatitis C except genotype 1 and high pretreatment viremia.
Scientific Title
A dose comparing study of peginterferon alfa-2b plus ribavirin in chronic hepatitis type C except genotype 1 and high pretreatment viremia.: A randomized open-label pilot study.
Scientific Title:Acronym
peginterferon alfa-2b plus ribavirin combination therapy for chronic hepatitis C except genotype 1 and high pretreatment viremia.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of initial dose of peginterferon alfa-2b (1.5microg/kg or 1.0microg/kg ) in two groups of patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virologic response
Key secondary outcomes
Safety ( moniterd clinical and laboratory evaluation)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
initial dose of PegIFN 1.5microg/kg
Interventions/Control_2
initial dose of PegIFN 1.0microg/kg
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
Naive case: genotype 2 and high pretreatment viremia Re treatment: except genotype 1 and high pretreatment viremia.
Key exclusion criteria
1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b or other interferons 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Chayama |
Organization
graduate school of biomedical science, Hiroshima university.
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiiku Kawakami |
Organization
graduate school of biomedical science, Hiroshima university
Division name
Department and medicine and molecular science
Zip code
Address
1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL
082-257-5190
Homepage URL
Sponsor or person
Institute
Hiroshima liver study group
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2006 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 01 | Month | 27 | Day |
Last modified on
| 2012 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000405
