UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comprehensive analyses of viral factors in hepatitis C patients receiving interferon-related therapy.
Title of the study (Brief title)	Comprehensive analyses of viral factors in hepatitis C patients
Region	Japan

Condition
Condition	hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the viral factors that determine the efficacy of anti-viral therapy on patients with chronic hepatitis C
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between the efficacy of the therapy and the mutations of hepatitis C viral sequences
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis caused by hepatitis C virus infeciton
Key exclusion criteria	Patients without the indication of anti-viral therapy
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroyuki Marusawa
Organization	Graduate School of Medicine, Kyoto University
Division name	Dep.Gastroenterology and Hepatology
Address	Shogoin-Kawaracho 54, Sakyo-ku, Kyoto
TEL	075-751-4319
Email	maru@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroyuki Marusawa
Organization	Graduate School of Medicine, Kyoto University
Division name	Dep.Gastroenterology and Hepatology
Address	Shogoin-Kawaracho 54, Sakyo-ku, Kyoto
TEL	075-751-4319
Homepage URL
Email	maru@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 12 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We examine whether the certain viral mutations of hepatitis C genomes are associated with the efficacy of the anti-viral therapy in patients with chronic hepatitis C.

Management information
Registered date	2009 Year 07 Month 28 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002768