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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000196
Receipt No. R000000270
Scientific Title Efficacy of combination therapy IFN-alpha-2b and ribavirin for patients with Serogroup2 and high titer HCV / without Serogroup1 and high titer HCV.
Date of disclosure of the study information 2008/12/31
Last modified on 2019/08/02

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Basic information
Public title Efficacy of combination therapy IFN-alpha-2b and ribavirin for patients with Serogroup2 and high titer HCV / without Serogroup1 and high titer HCV.
Acronym Combination therapy of IFN-alpha-2b and ribavirin.
(Serogoup2 and high titer)
(Not serogoup1 and high titer)
Scientific Title Efficacy of combination therapy IFN-alpha-2b and ribavirin for patients with Serogroup2 and high titer HCV / without Serogroup1 and high titer HCV.
Scientific Title:Acronym Combination therapy of IFN-alpha-2b and ribavirin.
(Serogoup2 and high titer)
(Not 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 IFN-alpha-2b and ribavirin for patients with Serogroup2 and high titer of HCV / without 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 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
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 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 24weeks treatment with IFN-alpha-2b plus ribavirin
Interventions/Control_2 24weeks treatment with IFN-alpha-2b plus ribavirin and 24weeks tretment with IFN-alpha-2b
Interventions/Control_3 24weeks treatment with IFN-alpha-2b plus ribavirin
Interventions/Control_4 24weeks treatment with IFN-alpha-2b plus ribavirin
Interventions/Control_5 Treatment with low-dose IFN after 24weeks 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 CHC(Serogroup2 and high titer)
CHC(Not serogroup1 and high titer)
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 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 200

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
Email 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 Yamadaoka2-2 Suita City
TEL 81-6-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Institute
Department

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
Email 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
2008 Year 06 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 13 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000270

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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