UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.
Title of the study (Brief title)	Antiviral therapy for HCV after treatment of hepatocelluler carcinoma.
Region	Japan

Condition
Condition	Hepatitis C after treatment for hepatocelluler carcinoma.
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify the antiviral therapy for inhibition of recurrence after treatment for hepatocelluler carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of recurrence survival rate
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	1) HCV genotype 1b 2) Neutrophil >=1,500 /mm3 PLT >= 75,000 /mm3 3) >=3 months post HCC treatment 4) CH or LC(Child-Pugh A) 5) within HCC stage 3 6) including post PSE/splenectomy cases
Key exclusion criteria	Patients judged by doctor that participation in the study is improper
Target sample size	100

Research contact person
Name of lead principal investigator	Kouji Joko
Organization	Matsuyama Red Cross Hospital
Division name	Center for liver-Biliary-Pancreatic Diseases
Address	1 Bunkyo-cho, Matsuyama-shi, EHIME
TEL	089-924-1111
Email	Koujijoko@matsuyama.jrc.or.jp

Public contact
Name of contact person	Toshie Mashiba
Organization	Matsuyama Red Cross Hospital
Division name	Center for liver-Biliary-Pancreatic Diseases
Address	1 Bunkyo-cho, Matsuyama-shi, EHIME
TEL	089-924-1111
Homepage URL
Email	matoshi@matsuyama.jrc.or.jp

Sponsor
Institute	Musashino Red Cross Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 25 Day
Anticipated trial start date	2014 Year 09 Month 01 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	Partially published
URL releasing results
Results
Other related information	Comparison of DAAs(daclatasvir and asunaprevir) and interferon-based triple therapy for hepatitis C after treatment for hepatocelluler carcinoma in Red Cross Hospital in Japan.

Management information
Registered date	2014 Year 08 Month 27 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017401