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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000646
Receipt No. R000000778
Scientific Title Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load
Date of disclosure of the study information 2014/03/01
Last modified on 2015/08/30

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Basic information
Public title Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load
Acronym GLSG,2007,PEG-Riba
Scientific Title Randomized controlled trial of 72-week Peg-IFN alpha-2b/ribavirin therapy with or without EPL (polyenephosphatidylcholine) for chronic hepatitis C patients with genotype 1b and high viral load
Scientific Title:Acronym GLSG,2007,PEG-Riba
Region
Japan

Condition
Condition Chronic hepatitis C with serotype 1 and high viral load
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 EPL add-on Peg-IFN alpha-2b/ribavirin therapy in comparison to Peg-IFN alpha-2b/ribavirin without EPL therapy for chronic hepatitis C
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1.The improvement of sustained viral response
2.The frequency of dose reduction of ribavirin due to anemia
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group of Peg-IFN alpha/rivavirin with EPL therapy
Interventions/Control_2 The group of Peg-IFN alpha/rivavirin without EPL therapy
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. The cases of HCV-RNA-positive with serogroup 1 and high viral load
2. The cases without regard to the history of IFN therapy
3. The cases diagnosed as chronic hepatitis by liver biopsy within 12 months
Key exclusion criteria 1.The complication of the other liver diseases
2.Liver cirrhosis
3.Prick test-positive
4.IFN,rivavirin or EPL sensitivity
5.During pregnancy, the possibility of pregnancy or during lactation
6.Depression
7.The possibility of autoimmune diseases
8.Uncontrolled diabetes
9.Uncontrolled hypertension
10.While taking Sho-saiko-to
11.Febrile condition
12.Hematopenia
13.Poor function of bone marrow, kidney, heart or lung


Target sample size 200

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 3-39-15 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 3-39-15 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

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
2014 Year 03 Month 01 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
2007 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2014 Year 03 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
2007 Year 03 Month 17 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=R000000778

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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