UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000175 |
|---|---|
| Receipt number | 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 17:21:17 |
* 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
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
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
kakizaki@showa.gunma-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000243
