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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000392
Receipt No. R000000483
Scientific Title Treatment efficacy of pegintron alpha-2b and rivavirin for chronic hepatitis C patients with genotype 2 and high viral loads based on the dissapearance speed of serum HCV-RNA
Date of disclosure of the study information 2012/12/31
Last modified on 2015/08/30

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Basic information
Public title Treatment efficacy of pegintron alpha-2b and rivavirin for chronic hepatitis C patients with genotype 2 and high viral loads based on the dissapearance speed of serum HCV-RNA
Acronym GLSG,2006,Pegintron
Scientific Title Treatment efficacy of pegintron alpha-2b and rivavirin for chronic hepatitis C patients with genotype 2 and high viral loads based on the dissapearance speed of serum HCV-RNA
Scientific Title:Acronym GLSG,2006,Pegintron
Region
Japan

Condition
Condition chronic hepatitis C with genotype 2 and high viral loads
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of peginterferon alpha-2b and ribavirin therapy for chronic hepatitis C with genotype 2 and high viral loads based on the dissapearance speed of HCV-RNA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes virological responses and
predictive factors associated each virological responses
Key secondary outcomes safety, dose reduction and discontinuation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pegintron alpha-2b/rivavirin for 12 weeks for SRVR group
Interventions/Control_2 pegintron alpha-2b/rivavirin for 24 weeks for RVR group
Interventions/Control_3 pegintron alpha-2b/rivavirin for 48 weeks for LVR group
Interventions/Control_4 pegintron alpha-2b/rivavirin for 24 weeks for LVR group
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
75 years-old >
Gender Male and Female
Key inclusion criteria chronic hepatitis C with genotype 2
positive test of HCV-RNA and pretreatment viral load
is more than 100 KIU/mL
negative test of HBsAg
Key exclusion criteria chronic liver disease arising from other etiology
allergy to interferon (IFN)
during pregnancy
severe complications-especially bone marrow, renal,cardiac, or respiratory dysfunction
Target sample size 150

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, Japan
TEL 0272-20-8127
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, Japan
TEL 0272-20-8127
Homepage URL
Email satoken@showa.gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group (GLSG)
Institute
Department

Funding Source
Organization Gunma Liver Study Group (GLSG)
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
2012 Year 12 Month 31 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
2005 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 02 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=R000000483

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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