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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000235
Receipt No. 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

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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
Email

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
Email takeda@med.osaka-cu.ac.jp

Sponsor
Institute Department of Hepatology, Graduate School of Medicine, Osaka City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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