UMIN-CTR Clinical Trial

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