UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection.
Title of the study (Brief title)	New algorithm for antiviral therapies in patients with chronic hepatitis C.
Region	Japan

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

Objectives
Narrative objectives1	Establish a new algorithm for antiviral therapies based on HCV NS5A mutation status in patients with chronic hepatitis C infection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SVR
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	asunaprevir, daclatasvir
Interventions/Control_2	Simeprevir, peginterferon, ribavirin
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) naive, null responder, patial responder 2) over 20 years old 3) HCV RNA level >100,000 IU/mL for naive patient 4) Dropout patients. 5) ban for pregancy 6) get informed concent
Key exclusion criteria	1) liver failure 2) liver chrosis for SMV group 3) liver disease other than CHC 4) HCC 5) coinfection with HIV and/or HBV 6) other than genotype 1b 7) allegry for drugs i this study 8) contraindication for drugs in this study 9) pregnacy
Target sample size	230

Research contact person
Name of lead principal investigator	Hidemi Goto
Organization	Nagoya University
Division name	Gastroenterology and hepatology
Address	65 tsuruma showa Nagoya Aichi
TEL	052-741-2111
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	Kazuhiko Hayashi
Organization	Nagoya University
Division name	Gastroenterology and hepatology
Address	65 tsuruma showa Nagoya Aichi
TEL	052-741-2111
Homepage URL
Email	kazuh@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Janssen
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 05 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2016 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019469