UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of paritaprevir and ombitasvir with a booster dose of ritonavir in genotype 1 HCV patients with hemodialysis
Title of the study (Brief title)	Viek-tory HD study
Region	Japan

Condition
Condition	hemodialysis patients chronically infected with genotype 1 hepatitis C virus
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of paritaprevir and ombitasvir with a booster dose of ritonavir in a prospective study of genotype 1 HCV patients with hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	antiviral effect (24 weeks after end of administration)
Key secondary outcomes	1) antiviral effect (4 weeks after end of administration) 2) the improvement of liver function at the end of treatment 3) adverse events

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	administration of paritaprevir and ombitasvir with a booster of ritonavir 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients with written consent of this study 2) patients infected with HCV genotype 1 with chronic hepatitis or with compensated cirrhosis 3) patients without contraindications to paritaprevir, ombitasvir, or ritonavir.
Key exclusion criteria	1) patients who are allergic to paritaprevir, ombitasvir, or ritonavir. 2) patients with decompensated cirrhosis (Child-Pugh Class B or C) 3) pregnant women and women suspected of being pregnant 4) patients ineligible for some other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	Takamasa Ohki
Organization	Mitsui Memorial Hospital
Division name	Department of Gastroenterology
Address	1, Kandaizumi-cho, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Email	anb72547@nifty.com

Public contact
Name of contact person	Takamasa Ohki
Organization	Mitsui Memorial Hospital
Division name	Department of Gastroenterology
Address	1, Kandaizumi-cho, Chiyoda-ku, Tokyo
TEL	03-3862-9111
Homepage URL
Email	anb72547@nifty.com

Sponsor
Institute	Mitsui Memorial Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
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 06 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 06 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	2016 Year 06 Month 01 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025872