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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000175
Receipt No. R000000243
Scientific Title Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.
Date of disclosure of the study information 2005/09/12
Last modified on 2015/09/04

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Basic information
Public title Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.
Acronym GLSG PEG/Rib 2005
Scientific Title Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.
Scientific Title:Acronym GLSG PEG/Rib 2005
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will evaluate the optimal treatment period of combination therapy with peginterferon alpha-2b and ribavirin for chronic hepatitis C.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained virological response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Negative for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48weeks)
Interventions/Control_2 Positive for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48 weeks)
Interventions/Control_3 Positive for HCVRNA at 4 weeks of therapy.
PEG-IFN alpha-2b/ribavirin (48 weeks) plus IFN alpha-2b (24weeks)
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 (1)Chronic hepatitis C with genotype Ia/Ib and high titer (more than 100KIU/ml)
(2)Chronic hepatitis confirmed with liver biopsy.
(3)Abnormal ALT
Key exclusion criteria (1)Complicated with other liver diseases such as autoimmune hepatitis and alcoholic liver injury.
(2)Liver cirrhosis, hepatic failure.
(3)Drug allergy for IFN or ribavirin.
(4)Drug allergy for vaccine.
(5)Administration of other anti-viral or immunomodulatory treatment.
(6)Pregnancy.
(7)Depression.
(8)Complicated with autoimmune disorders.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Takagi
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8127
Email htakagi@med.gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Kakizaki
Organization Gunma University Graduate School of Medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL 027-220-8127
Homepage URL
Email kakizaki@showa.gunma-u.ac.jp

Sponsor
Institute Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
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
2005 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
Not significant change
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
2004 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
2009 Year 01 Month 01 Day
Date trial data considered complete
2009 Year 01 Month 31 Day
Date analysis concluded
2009 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2015 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000243

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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