UMIN-CTR Clinical Trial

Basic information
Public title	Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients
Acronym	Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy
Scientific Title	Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients
Scientific Title:Acronym	Examination of virological response and predictive factors in Elbasvir/Grazoprevir combination therapy
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the predictive factors associated with virological response and efficacy in Elbasvir/Grazoprevir combination therapy for genotype1 infected chronic hepatitis C patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sustained virological response 12 rate
Key secondary outcomes	1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.

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	Treat with Elbasvir/Grazoprevir combination therapy ERELSA 50mg:one tablet once a day for 12 weeks GRAZYNA 50mg:two tablets once a day 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	18 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who treated with Elbasvir/Grazoprevir combination therapy. Patients with chronic hepatits C, genotype 1
Key exclusion criteria	1.History of allergy to Elbasvir/Grazoprevir 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Receiving contraindicated drugs for Elbasvir/Grazoprevir combined therapy
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Tomomi Middle name Last name Okubo
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1196
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476991111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Okubo
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1196
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476991111
Homepage URL
Email	ma6-0154@nms.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Nippon Medical School Hospital Nippon Medical School Musashi Kosugi Hospital The Jikei University Hospital Otakanomori Hospital Hakujikai Healthcare foundation Tokyo Metropolitan Bokutoh Hospital Tokyo Medical University Ibaraki Medical Center Shinmatsudo Central General Hospital Japanese Red Cross Narita Hospital Nagoya City University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nipon medical Chiba hokuso Hospital
Address	1715 Kamagari Inzai Chiba
Tel	0476991111
Email	araraki@nms.ac.jp

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	2017 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 06 Month 21 Day
Date of IRB	2017 Year 06 Month 05 Day
Anticipated trial start date	2017 Year 07 Month 05 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 24 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033447