UMIN-CTR Clinical Trial

Basic information
Public title	peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study
Acronym	peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C
Scientific Title	peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C : A pilot study
Scientific Title:Acronym	peginterferon alfa-2b and ribavirin plus pitavastatin for chronic hepatitis type C
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of peginterferon alfa-2b and ribavirin plus pitavastatin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Sustained virologic response
Key secondary outcomes	1) virologic response at 4,8,12,16,20,24weeks and end of therapyt 2) Safety ( moniterd clinical and laboratory evaluation)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	peginterferon alfa 2b and ribavirin plus pitavastatin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	genotype 1 and high virus load
Key exclusion criteria	1) Patients receiving shosaiko-to 2) Autoimmune hepatitis 3) History of hypersensitivity to PEG-IFN alpha-2b 4) History of hypersensitivity to biological products such as vaccine 5) Decompenstated liver cirrhosis 6) HCC, malignat tumor 7) With or with a history of severe psychosis such as severe depression, suicidal ideation or attempt, etc. 8) Pregnant or lactating women and women who may be pregnant 9) Judged by investigator not to be appropriate for inclusion in this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuaki Chayama
Organization	graduate school of biomedical science, Hiroshima university.
Division name	Department and medicine and molecular science
Zip code
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshiiku Kawakami
Organization	graduate school of biomedical science, Hiroshima university
Division name	Department and medicine and molecular science
Zip code
Address	1-2-3 kasumi, minami-ku, Hiroshima 734-8551
TEL	082-257-5190
Homepage URL
Email

Sponsor
Institute	Hiroshima liver study group
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
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	2008 Year 12 Month 26 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	Completed
Date of protocol fixation	2008 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2012 Year 01 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	2008 Year 12 Month 26 Day
Last modified on	2012 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001926

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.