UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000646 |
|---|---|
| Receipt number | 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 10:23:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
satoken@showa.gunma-u.ac.jp
Sponsor or person
Institute
Gunma Liver Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000778
