UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000197 |
|---|---|
| Receipt number | R000000266 |
| Scientific Title | Efficasy of combination therapy PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer HCV. |
| Date of disclosure of the study information | 2008/12/31 |
| Last modified on | 2020/03/25 22:13:07 |
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Basic information
Public title
Efficasy of combination therapy PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer HCV.
Acronym
Combination therapy of PEG-IFN-alpha-2b and Ribavirin.(Serogoup1 and high titer)
Scientific Title
Efficasy of combination therapy PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer HCV.
Scientific Title:Acronym
Combination therapy of PEG-IFN-alpha-2b and Ribavirin.(Serogoup1 and high titer)
Region
| Japan |
Condition
Condition
Hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We estimate the efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for patients with Serogroup1 and high titer of HCV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC
Efficacy of additional IFN therapy for intractable CHC
Efficacy of combination therapy of 48 weeks PEG-IFN-alpha-2b and Ribavirin for ASC
Efficacy of combination therapy of PEG-IFN-alpha-2b and Ribavirin for CHC with advanced fibrosis
Efficacy of low-dose IFN therapy for intractable CHC
Efficacy of ribavirin early dose down reguration for CHC
Analysis of DC function and HCV specific CTL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
48weeks treatment with PEG-IFN-alpha-2b plus ribavirin
Interventions/Control_2
48 or 72weeks treatment with PEG-IFN-alpha-2b plus ribavirin
Interventions/Control_3
48weeks treatment with PEG-IFN-alpha-2b plus ribavirin
Interventions/Control_4
24weeks treatment with PEG-IFN-alpha-2b plus ribavirin
Interventions/Control_5
Retreatment with IFN-alpha-2b after 24weeks treatment with PEG-IFN-alpha-2 plus ribavirin
Interventions/Control_6
Treatment with continual low-dose IFN after 24weeks treatment with PEG-IFN-alpha-2 plus ribavirin
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CHC(Serogroup1 and high titer)
Initial or retreatment with interferon
Key exclusion criteria
Pregnant or lactating women and women who may be pregnant
Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment
Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment
History of hypersensitivity to ribavirin or other nucleoside analogs
Inadequately controlled cardiac disease
Hemoglobinopathy
Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less
With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
Serious hepatic function disorder
Autoimmune hepatitis
History of hypersensitivity to PEG-IFN alfa-2b or other interferons
History of hypersensitivity to biological products such as vaccine
Patients receiving shosaikoto
Judged by investigator to be not appropriate for inclusion in study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka university graduate school of medicine
Division name
Gastroenterology and hepatology
Zip code
565-0871
Address
Yamadaoka2-2 Suita City
TEL
81-6-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryotaro |
| Middle name | |
| Last name | Sakamori |
Organization
Osaka university graduate school of medicine
Division name
Gastroenterology and hepatology
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
81-6-6879-3621
Homepage URL
sakamori@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2008 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2004 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000266
