UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001170 |
|---|---|
| Receipt number | R000001430 |
| Scientific Title | Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2015/08/30 10:19:26 |
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Basic information
Public title
Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road
Acronym
GLSG, 2008, Pegasys
Scientific Title
Treatment efficacy of short-term PEG-IFN alpha for chronic hepatitis C patients with genotype 2 and low viral road
Scientific Title:Acronym
GLSG, 2008, Pegasys
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 PEG-IFN alpha therapy for chronic hepatitis C patients with genotype 2 and low viral load with early dissapearance of HCV-RNA by PEG-IFN alpha.
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
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
a group of short-term PEG-IFN alpha therapy
Interventions/Control_2
a group of ordinary-term PEG-IFN alpha 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
Chronic hepatitis C
genotype 2
positive test of HCV-RNA and less than 5 LogIU/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
220
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@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 | 05 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | 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
| 2008 | Year | 06 | Month | 02 | 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=R000001430
