UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of DAAs therapy for patients with HCV infection on prognosis and incidence of HCC
Title of the study (Brief title)	Effect of DAAs on incidence of HCC and prognosis
Region	Japan

Condition
Condition	Patients with HCV infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To analyze the effect of DAAs therapy for HCV infected patients on HCC incidence,risk maker of incidence of HCC and prognosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate incidence of HCC and prognosis after HCV eradication. To analyze risk factor of those
Key secondary outcomes	1 HCC incidence and prognosis in HD patients with HCV infection. To compare HCC incidence and prognosis between patient with or without IFN-therapy 2 To investigate change in ALT and AFP 3 To investigate the change in liver fibrosis and steatosis after SVR 4 To investigate the change in lipid/glucose/Fe metabolismafter SVR 5 To investigate the rate of Hospitalization due to liver disease

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	Not applicable
Gender	Male and Female
Key inclusion criteria	HCV infected patients who were treated and achieved SVR between 2011 and 2026
Key exclusion criteria	1) Patients with difficult-to-control heart disease 2) Other patients judged to be inappropriate to participate in the study by the primary physician
Target sample size	400

Research contact person
Name of lead principal investigator	Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	Goki Suda
Organization	Graduate School of Medicine, Hokkaido University
Division name	Department of Gastroenterology and Hepatology
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-716-2111
Homepage URL
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Graduate School of Medicine, Hokkaido University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Hokkaido University
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 01 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 05 Month 28 Day
Last follow-up date
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	1) patients background 2) blood count 3) biochemical examination 4) tumor maker 5) HCV RNA, RAV 6) glucose, lipid metabolism 7) fibrosis maker 8) radiological exmamination 9) concomitant drug 10) admission due to liver disease 11) micro RNA 12) microbiota

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035510