UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir in chronic hepatitis C patients
Title of the study (Brief title)	Efficacy of Ombitasvir/Paritaprevir/Ritonavir in 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	To assessment of efficacy and safety of Ombitasvir/Paritaprevir/Ritonavir in chronic hepatits C patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Sustained virologic response rate at 12 weeks post-treatment
Key secondary outcomes	Safety The factor associated with sustained virologic response Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma

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	Ombitasvir/Paritaprevir/Ritonavir 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	(1) Chronic hepatitis or cirrhosis patients with HCV genotype 1 (2) Patients with 20 years of age and olde
Key exclusion criteria	(1) Decompensated cirrhosis, Liver failure (2)patients with hepatic cell carcinoma (3) Co-infection with hepatitis B virus Co-infection with anti- humanimmunodeficiency virus
Target sample size	100

Research contact person
Name of lead principal investigator	Kinbara Takeshi
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 okamoto,kamakura, kanagawa, japan
TEL	0467-46-1717
Email	t_kinbara@shonankamakura.or.jp

Public contact
Name of contact person	Uojima haruki
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 okamoto,kamakura, kanagawa, japan
TEL	0467-46-1717
Homepage URL
Email	kiruha555@yahoo.co.jp

Sponsor
Institute	shonan kamakura general hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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 02 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 12 Day
Last follow-up date	2017 Year 10 Month 31 Day
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	2016 Year 02 Month 21 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024372