UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy of elbasvir and glazopurevir for Japanese hepatitis C patients: a prospective study in real life settings.
Title of the study (Brief title)	The efficacy of elbasvir and glazopurevir for Japanese hepatitis C patients.
Region	Japan

Condition
Condition	cirrhotic and noncirrhotic patients with chronic hepatitis C virus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Identifying the predictive factors of virological response in elbasvir and glazoprevir treatment.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	sustained virological response (SVR) at 12 week and 24 week after the end of treatment
Key secondary outcomes	incidence rate of adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	elbasvir 50mg and glazoprevir 100mg once daily for 12 weeks
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	chronic hepatitis C and compensated cirrhotic patients with HCV genotype 1b
Key exclusion criteria	decompensated cirrhosis
Target sample size	100

Research contact person
Name of lead principal investigator	Fumitaka Suzuki
Organization	Toranomon Hospital
Division name	hepatology
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Email	hitomis@mx1.harmonix.ne.jp

Public contact
Name of contact person	Hitomi Sezaki
Organization	Toranomon Hospital
Division name	hepatology
Address	2-2-2, Toranomon, Minato-ku, Tokyo
TEL	03-3588-1111
Homepage URL
Email	hitomis@mx1.harmonix.ne.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 10 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 21 Day
Anticipated trial start date	2017 Year 12 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	2017 Year 04 Month 08 Day
Last modified on	2017 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030867