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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000204
Receipt No. R000000267
Scientific Title Treatment efficacy of short-term consensus IFN for chronic hepatitis C
Date of disclosure of the study information 2009/09/12
Last modified on 2015/08/30

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Basic information
Public title Treatment efficacy of short-term consensus IFN for chronic hepatitis C
Acronym GLSG,2005,CIFN
Scientific Title Treatment efficacy of short-term consensus IFN for chronic hepatitis C
Scientific Title:Acronym GLSG,2005,CIFN
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of short-term consensus IFN therapy for patients with chronic hepatitis C with early dissapearance of HCV-RNA by consensus IFN.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes HCV-RNA
Key secondary outcomes transaminase

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 Consensus IFN
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 Chronic hepatitis C
positive test of HCV-RNA and less than 100KIU/ml of HCV-RNA viral load
abnormal transaminase
negative test of HBsAg
Key exclusion criteria liver dysfunction with other causes
Allergy to Interferon (IFN)
during pregnancy
Severe comlication-especially,
poor hematopoiesis, renal, cardiac or respiratory function
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa, Maebashi, Gunma, 371-8511, Japan
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-22 Showa, Maebashi, Gunma, 371-8511, Japan
TEL 027-220-8127
Homepage URL
Email satoken@showa.gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group
Institute
Department

Funding Source
Organization Gunma Liver Study Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2009 Year 09 Month 12 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 Completed
Date of protocol fixation
2005 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2010 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2015 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000267

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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