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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000313
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima liver study group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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