UMIN-CTR Clinical Trial

Basic information
Public title	Predictive factors associated with virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Acronym	Virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Scientific Title	Predictive factors associated with virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Scientific Title:Acronym	Virological response in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a infected chronic hepatitis C patients
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Inspection of the curative effect and to confirm the predictive factors associated with virological response and in Ombitasvir/Paritaprevir/Ritonavir/Ribavirin combination therapy for genotype2a 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 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 Ombitasvir/Paritaprevir /Ritonavir/Ribavirin combination therapy.
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	Case of introducing ombitasvir/paritaprevir/ritonavir/ribavirin combination therapy for Genotype 2 type C chronic liver disease
Key exclusion criteria	1History of allergy to Ombitasvir/Paritaprevir /Ritonavir/Ribavirin 2Liver cirrhosis 3Patients with creatinine clearance less than 50 ml / min 4Pregnant woman or lactating mother 5Hepatocellular carcinoma, or other malignant tumor 6Judged by investigator not to be appropriate for inclusion in this study
Target sample size	300

Research contact person
Last name of lead principal investigator	1st name Masanori Middle name Last name Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code	270-1694
Address	1715 Kamagari Inzai Chiba
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
1st 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	2701694
Address	1715 Kamagari Inzai Chiba
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nipppon 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Chiba Hokusoh Hospital institutional review board
Address	1715, Kamakari, Inzai, Chiba, Japan
Tel	0476-99-1111
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 03 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	98
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	Completed
Date of protocol fixation	2017 Year 01 Month 12 Day
Date of IRB	2017 Year 01 Month 12 Day
Anticipated trial start date	2017 Year 01 Month 16 Day
Last follow-up date	2018 Year 12 Month 28 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 03 Month 22 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030595