UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Title of the study (Brief title)	Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Region	Japan

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

Objectives
Narrative objectives1	The non-inferiority of IFN-free therapy to IFN-based therapy on risk for hepatocellular carcinoma in patients with SVR
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rates of hepatocarcinogenesis
Key secondary outcomes	Overall survival Rates of SVR Rates of interruption of antiviral therapy due to adverse effect

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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic hepatitis C patients aged 70 years or older undergoing antiviral therapy (IFN-free or IFN-based) after 2004.
Key exclusion criteria	Present illness or past history of hepatocellular carcinoma Positive Hepatitis B viral DNA
Target sample size	516

Research contact person
Name of lead principal investigator	Shinji Katsushima
Organization	Kyoto Medical Center, National Hospital Organization
Division name	Department of Gastroenterology
Address	1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL	81-75-641-9161
Email	skatsush@kyotolan.hosp.go.jp

Public contact
Name of contact person	Shinji Katsushima
Organization	Kyoto Medical Center, National Hospital Organization
Division name	Department of Gastroenterology
Address	1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL	81-75-641-9161
Homepage URL
Email	skatsush@kyotolan.hosp.go.jp

Sponsor
Institute	R24 Liver Conference
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology and Hepatology, Kansai Electric Power Hospital Center for Digestive and Liver Diseases, Nara City Hospital Department of Gastroenterology, Tenri Hospital Center for Digestive and Liver Diseases, Japan Commnunity Health care Organization Hoshigaoka Medical Center Department of Gastroenterology and Endocrinology, Nara Hospital, Kinki University School of Medicine Department of Gastroenterology, Yamato Koriyama Hospital Department of Gastroenterology, Matsushita Memorial Hospital Department of Gastroenterology and Hepatology, Kyoto Yamashiro General Medical Center Department of Gastroenterology, Kyoto Kizugawa Hospital Department of Gastroenterology, Mitsubishi Kyoto Hospital Department of Gastroenterology and Hepatology, Uji Takeda Hospital
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	2015 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 02 Month 06 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry	2024 Year 03 Month 31 Day
Date trial data considered complete	2024 Year 06 Month 30 Day
Date analysis concluded	2024 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Comparison between IFN-free and IFN-based therapy in hepatitis C patients: risk for hepatocellular carcinoma.

Management information
Registered date	2015 Year 04 Month 29 Day
Last modified on	2016 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020105