UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000235 |
|---|---|
| Receipt number | R000000213 |
| Scientific Title | Efficacy of long term combination therapy of PEG-IFN-alpha-2b and Ribavirin for patients with chronic hepatitis C |
| Date of disclosure of the study information | 2009/12/31 |
| Last modified on | 2006/04/20 13:47:12 |
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Basic information
Public title
Efficacy of long term combination therapy of PEG-IFN-alpha-2b and Ribavirin for patients with chronic hepatitis C
Acronym
Long term thrapy of PEG-IFN-alpha-2b and Ribavirin
Scientific Title
Efficacy of long term combination therapy of PEG-IFN-alpha-2b and Ribavirin for patients with chronic hepatitis C
Scientific Title:Acronym
Long term thrapy of PEG-IFN-alpha-2b and Ribavirin
Region
| Japan |
Condition
Condition
Patients with chronic 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+Ribavirin for patients with genotype 1b and high titer of HCV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sustained viral response rate at 24 weeks after the end of therapy
Key secondary outcomes
Nomalization of ALT at 24 weeks after the end of therapy
safty of therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
48weeks treatment with PEG-IFN=alpha-2b plus ribavirin.
Interventions/Control_2
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24weeks treatment with IFN-alpha-2b.
Interventions/Control_3
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24w treatment with IFN-alpha -2b plus ribavirin.
Interventions/Control_4
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin.
Interventions/Control_5
48weeks treatment with PEG-IFN=alpha-2b plus Ribavirin, and 24w treatment with IFN-alpha -2b plus ribavirin.
Interventions/Control_6
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
patients with genotype 1b and high titer og HCV
Key exclusion criteria
(1) Pregnant or lactating women and women who may be pregnant
(2) Female patients or male patients with partners who may become pregnant who cannot practice contraception during treatment and 6 months after end of treatment
(3) Male patients with pregnant partners who cannot comply with condom use during treatment and 6 months after end of treatment
(4) History of hypersensitivity to ribavirin or other nucleoside analogs
(5) Inadequately controlled cardiac disease
(6) Hemoglobinopathy
(7) Chronic renal failure or renal function disorder with creatinine clearance of 50 ml/min or less
(8) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc.
(9) Serious hepatic function disorder
(10) Autoimmune hepatitis
(11) History of hypersensitivity to PEG-IFN alfa-2b or other interferons
(12) History of hypersensitivity to biological products such as vaccine
(13) Patients receiving shosaikoto
(14) Judged by investigator to be not appropriate for inclusion in study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Takeda |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku Osaka
TEL
06-6645-3811
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Takeda |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku Osaka
TEL
Homepage URL
takeda@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
non
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
| 2009 | 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
Date of protocol fixation
| 2004 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | 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
| 2005 | Year | 09 | Month | 14 | Day |
Last modified on
| 2006 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000213
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